[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-myelomonocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-myelomonocytic-leukemia":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,47,75,98,127,152,173,202,238,277,299,335,358,399,434,461,485,515,540,565,586,605,623,642,666],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100578723","phase-2-vedolizumab-plus-post-transplant-cyclophosphamide-and-short-course-tacrolimus-for-the-prevention-of-graft-versus-host-disease-in-patients-undergoing-allogeneic-hematopoietic-cell-transplantation-after-reduced-intensity-conditioning-100578723",false,"NCT06815003","Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation After Reduced Intensity Conditioning","Phase-2 Study of Vedolizumab Plus Post-Transplant Cyclophosphamide and Short Course Tacrolimus for Graft-versus-Host Disease Prevention After Reduced Intensity Conditioning Peripheral Blood Stem Cell Allogeneic Hematopoietic Cell Transplantation","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 and ≤ 80 years old\n\n  * Note: Patients \\> 70 years of age must have Karnofsky performance status ≥ 80 and hematopoietic cell transplantation-comorbidity index (HCT-CI) ≤ 2\n* Karnofsky performance status ≥ 70%\n* Patients with the following diagnosis, eligible to undergo allogeneic HCT from an 8\u002F8 match related\u002Funrelated donor (A, B, C, DR by high resolution typing)\n\n  * Acute Leukemias (acute myeloid leukemia \\[AML\\] or acute lymphoblastic leukemia \\[ALL\\]) in complete remission with bone marrow (BM) blast of \\\u003C 5%\n  * Myelodysplastic syndrome (blast \\\u003C 10%)\n  * Myeloproliferative neoplasm (MPN) other than myelofibrosis (MF) needing HCT\n  * Chronic myelomonocytic leukemia (CMML)\n* Hemoglobin ≥ 9g\u002FdL (within 30 days prior to day 1 of protocol therapy)\n\n  * NOTE: Red blood cell transfusions are not permitted within 14 days of hemoglobin assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 2.0 mg\u002FdL (unless has Gilbert's disease) AND serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) \\\u003C 5 times the upper limit of normal (ULN) (within 30 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) =\\\u003C 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) =\\\u003C 3.0 x ULN (within 30 days prior to day 1 of protocol therapy)\n* Creatinine clearance of ≤ 1.5 mg\u002FdL or ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 30 days prior to day 1 of protocol therapy)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* IF ABLE TO PERFORM PULMONARY FUNCTION TESTS: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note To be performed within 28 days prior to day 1 of protocol therapy\n* IF UNABLE TO PERFORM PULMONARY FUNCTION TESTS: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note To be performed within 28 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen\u002Fantibody (Ag\u002FAb) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 30 days prior to day 1 of protocol therapy)\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Tuberculosis test (within 30 days prior to day 1 of protocol therapy)\n\n  * Patients with positive tuberculosis (TB) test results will have infectious disease (ID) evaluation and post HCT therapy with isoniazid (INH) for 6 months with ID follow up. Vaccinated patients will need negative chest X-ray results\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 30 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior allogeneic HCT\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy\n\n  * Note: Conditioning regimen within 14 days prior to day 1 of protocol therapy is not considered as an exclusion criterion. Patients on maintenance chemotherapy with agents listed are not excluded\n* Other investigational drugs for GVHD prophylaxis\n* Herbal medications\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection not responding to antibiotics\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Patients not expected to be available for follow-up in our institution for at least 100 days after the transplant\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)","ALL","18 Years","80 Years",{"count":21,"type":22},35,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This phase II trial studies how well vedolizumab plus post-transplant cyclophosphamide (PTCy) and short course tacrolimus work for the prevention of graft versus host disease (GVHD) in patients undergoing allogeneic hematopoietic cell transplantation (HCT) after reduced intensity conditioning. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a donor. Giving reduced conditioning chemotherapy before an allogeneic HCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new stem cells to grow using less than standard doses of chemotherapy. Sometimes, the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Vedolizumab is a monoclonal antibody, which is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). It may reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus suppresses the immune system by preventing the activation of certain types of immune cells. Giving vedolizumab plus PTCy and short course tacrolimus may be effective at preventing GVHD after allogeneic HCT.",[28,29,30,31,32,33],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Graft Versus Host Disease","Myelodysplastic Syndrome","Myeloproliferative Neoplasm","RECRUITING","2026-06-25",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":38},"2025-04-18",{"date":42,"type":22},"2028-10-15",{"name":44,"class":45},"City of Hope Medical Center","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100521594","phase-1-chimeric-antigen-receptor-t-cell-therapy-redirected-to-cd4-cd4caras-a-second-line-treatment-for-chronic-myelomonocytic-leukemia-cmml-100521594","NCT06071624","Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.","CD4CAR T Cell Therapy for CMML","Inclusion Criteria:\n\n1. ≥ 18 years old at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Diagnosis of CMML that is CD4+ and is recurrent or refractory to first line standard of care treatment.\n4. Creatinine clearance of ≥ 60 ml\u002Fmin (or otherwise non clinically significant, per study investigator)\n5. ALT\u002FAST \\\u003C 3 x ULN\n6. Bilirubin \\\u003C 2 x ULN\n7. No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion.\n8. Adequate cardiac function with EF of ≥50%. This will not have to be repeated if within 45 days of initial assessment\n9. Adequate venous access for apheresis and no other contraindications for leukapheresis\n\nExclusion Criteria:\n\n1. CD4 negative CMML\n2. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see definition below) must have a negative serum or urine pregnancy test prior to initiation of conditioning chemotherapy, per research sites' clinical policy\n3. Uncontrolled active infection necessitating systemic therapy\n4. Active hepatitis B or hepatitis C infection. Active hepatitis C is defined as the hepatitis C antibody is positive while quantitative HCV RNA results exceed the lower detection limit\n\n   Note the following subjects will be eligible:\n   * Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable viral DNA for 6 months prior to enrollment are eligible\n   * Subjects seropositive for HBS antibodies due to hepatitis B virus vaccine with no signs or active infection (Negative HBs Ag, HBc and HBe Ags) are eligible\n   * Subjects who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA for 6 months are eligible\n   * If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative\n5. Concurrent use of systemic glucocorticoids in greater than replacement doses or steroid dependency defined in rheumatological and pulmonary diseases as uninterrupted corticosteroid intake for more than a year at a dosage of 0.3 mg\u002Fkg\u002Fday or greater, and where the underlying disease worsens on temporary stoppage of steroid therapy, with symptoms of steroids withdrawal (eg, lethargy, headache, weakness, pseudo rheumatism, emotional disturbances, etc) precipitated by the temporary stoppage unless tapering can occur safely without compromising the underlying disease, the withdrawal tolerance and can happen in a timeframe appropriate to enroll in this trial without safety concerns\n\n   Subjects who receive daily corticosteroids in replacement doses can be included in the study. The replacement doses are defined as following:\n   1. Hydrocortisone 25mg\u002Fday or less\n   2. Prednisone 10mg\u002Fday or less\n   3. Dexamethasone 4mg or less - Note: Recent or current use of inhaled glucocorticoids is not exclusionary, as this route pertains extremely minimal systemic penetration\n6. Any uncontrolled active medical disorder that would preclude participation as outlined in the opinion of the treating investigator and\u002For Principal Investigator\n7. HIV infection\n8. Subjects who have received or will receive live vaccines within 30 days before the first experimental cell treatment. Inactivated seasonal flu vaccination is allowed\n9. Subjects with active autoimmune diseases who need systematic treatments (such as disease modifying agents, corticosteroids and immunosuppressive drugs) during the last year Note: Replacement therapy (thyroxine, insulin or physiological corticosteroid replacement therapy (up to10 mg of oral daily prednisone or equivalent in hydrocortisone and dexamethasone) to treat adrenal dysfunction or pituitary dysfunction) is not considered as systematic therapy. Subjects who need inhalation corticosteroid therapy can be included in this trial. Subjects with vitiligo or in long-term remission of pediatric asthma or allergic diseases can be included in this trial\n10. Subjects with a history of mental disorders or drug abuse that may influence treatment compliance\n11. Active malignancy not related to CMML that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the Principal Investigator CMML patients who transformed into AML and who were treated back into CMML status are eligible. CMML patients who transformed into AML and appropriate AML treatment was unsuccessful in reverting their disease back to CMML status will be treated as AML patients and are not eligible for the CMML study.\n12. Treatment with any investigational cell\u002Fgene therapy within the past 6 months\n13. Treatment with any investigational anticancer agent within the last 14 days of study entry or 5 half-lives (whichever is shorter)\n\nEligibility for Conditioning Chemotherapy:\n\n1. Specific organ function criteria for cardiac, renal, and liver function must be similar to initial inclusion values\n2. Review of co-morbidities to confirm no major changes in health status (examples of major changes include heart attack, stroke, and any major trauma)\n3. Planned infusion dose was successfully manufactured and met release criteria\n4. Negative pregnancy testing (if applicable)\n\nEligibility for cd4CAR Infusion Inclusion\n\n1. Afebrile and not receiving antipyretics, and no evidence of active infection. If fever is attributed to underlying disease, it will not disqualify.\n2. Specific organ function criteria for cardiac, renal, and liver function must be similar to initial inclusion values. The following test does not need repeated: EF if within 6 weeks of initial assessment.\n3. If previous history of corticosteroid chemotherapy, subject must be off all but adrenal replacement doses 3 days before the CD4CAR infusion\n\nExclusion\n\nNote: A subject may still receive the CD4CAR infusion up to 10 days post conditioning chemotherapy as long as they do not meet any of the following at time of infusion:\n\n1. Requirement for supplemental oxygen to keep saturation greater than 95% or presence of radiographic abnormalities on a clinically indicated chest x-ray that are progressive.\n2. New cardiac arrhythmia not controlled with medical management.\n3. Hypotension requiring pressor support.\n4. Positive blood cultures for bacteria, fungus, or virus within 48-hours of T cell infusion.\n\nContraception and Reproductive Potential Guidelines\n\nFemale subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test prior to conditioning chemotherapy.\n\nDue to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception from time of consent through at least 90 days after CD4CAR infusion.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide\n* Intrauterine device (IUD)\n* Hormonal-based contraception\n\nSubjects who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception. Acceptable documentation of sterilization, azoospermia, and menopause is specified next:\n\nWritten or oral documentation communicated by clinician or clinician's staff of one of the following:\n\n* Physician report\u002Fletter\n* Operative report or other source documentation in the subject record (a laboratory report of azoospermia is required to document successful vasectomy)\n* Discharge summary\n* Laboratory report of azoospermia\n* Follicle stimulating hormone measurement elevated into the menopausal range",{"count":55,"type":22},30,[57],"PHASE1","This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory CMML. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells.",[30],[30,61,62,63,64],"T Cell","Cell Therapy","CAR-T","chimeric antigen","2026-06-22",{"date":67,"type":38},"2026-06-24",{"date":69,"type":38},"2024-02-21",{"date":71,"type":22},"2043-12",{"name":73,"class":45},"Huda Salman",4,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100407137","phase-1-study-to-evaluate-the-safety-and-tolerability-of-ep0042-100407137","NCT04581512","Study to Evaluate the Safety and Tolerability of EP0042","A Modular, Multipart, Multi-arm, Open-label, Phase I\u002FIIa Study to Evaluate the Safety and Tolerability of EP0042 Alone and in Combination With Anti-cancer Treatments in Patients With Advanced Malignancies","General\n\n1. Male or female patients aged ≥ 18 years of age, at the time of informed consent, with histological or cytological confirmation of AML\n2. Ability to understand and provide written informed consent before any study-specific procedures, sampling, or analyses, including access to archival tumor tissue\n3. Ability to swallow and retain oral medication\n4. Sufficient life expectancy to allow the patient to complete at least 1 cycle (28 days) of the treatment period.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at screening\n6. In the opinion of the investigator, all other relevant medical conditions must be well-managed and stable for at least 28 days prior to first administration of study drug\n7. Patients with pathologically confirmed\u002Fdocumented AML or MDS, as defined by the 2022 European LeukaemiaNet (ELN) recommendations, or CMML, as defined by World Health Organization (WHO) criteria, who have relapsed from or are refractory to previous therapy and have failed all (or are not eligible for\u002Fintolerant to) available approved therapies for their disease.\n8. Patients with relapsed\u002Frefractory FLT3 WT AML.\n9. Previous exposure to venetoclax, hypomethylating agent and\u002For FLT3 inhibitors (gilteritinib, midostaurin, quizartinib, sorafenib) is allowed for relapsed\u002Frefractory AML patients.\n10. Mutation status of patients must be known at trial entry.\n11. Female patients should either be of non-child-bearing potential or must agree to use highly effective methods of contraception from Screening until 6 months following administration of the last dose of study drug\n12. Male patients must use double barrier contraception from enrolment through treatment and for 6 months following administration of the last dose of study drug\n\n5.2 Core Exclusion Criteria\n\nPatients with any of the following will not be included in the study:\n\nDisease Under Study and Prior Anticancer Treatment\n\n1. Suspected brain and\u002For leptomeningeal metastases that are symptomatic or untreated or that require current therapy\n2. Acute promyelocytic leukemia (FAB:M3)\n3. Systemic anti-cancer therapy for the disease under study within 2 weeks of the first dose of study treatment. If the previous anti-cancer therapy has a very long half-life and may interact with EP0042, e.g. a strong CYP3A4 inhibitor, the washout period may need to be increased for safety reasons but will be no longer than 3 weeks (Concomitant hydroxyurea is acceptable and will be permitted throughout the screening period and during first 6 cycles of study treatment)\n4. Ongoing toxic manifestations of previous treatments that have not reduced to at least CTCAE Grade 1. Exceptions to this are alopecia or certain Grade 2 treatment related toxicities, which in the opinion of the Investigator should not exclude the patient.\n5. Transplantation (allogeneic or autologous) within last 90 days, or on active immunosuppressive therapy for graft versus host disease in last 2 weeks\n\n   Laboratory Parameters\n6. Patient with any out-of-range laboratory values defined as shown below.\n\n   • Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) \\\u003C 50 mL\u002F min\n7. Inadequate liver function as demonstrated by\n\n   * total serum bilirubin ≥ 1.5 times the upper limits of normal range (ULN) or\n   * ALT ≥3 times the ULN or\n   * AST ≥3 times the ULN or\n   * AST or ALT ≥5 times the ULN in the presence of liver involvement by leukemia",{"count":83,"type":22},70,[57,25],"A research study looking at a new treatment for patients with advanced cancer, to investigate different doses of the experimental study drug, EP0042, in order to determine a dose, which is safe, well-tolerated and likely to be effective in treating AML (acute myeloid leukaemia).",[29,30,87],"Myelodysplastic Syndromes","2026-06-18",{"date":65,"type":38},{"date":91,"type":38},"2020-11-02",{"date":93,"type":22},"2027-12",{"name":95,"class":96},"Ellipses Pharma","INDUSTRY",6,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":46},"100295600","phase-1-211at-bc8-b10-before-donor-stem-cell-transplant-in-treating-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-myelodysplastic-syndrome-or-mixed-phenotype-acute-leukemia-100295600","NCT03128034","211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia","A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)\n  * AML evolved from myelodysplastic or myeloproliferative syndromes\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow)\n* Patients must be \\>= 18 and =\\\u003C 75 years of age\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed)\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault); serum creatinine value must be within 28 days prior to registration\n* Patients must have normal hepatic function (bilirubin within normal limits, aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\] \\\u003C 2 times the upper limit of normal) within 2 months prior to the astatine-211 infusion date (with the exception of patients that are known to have Gilbert's disease, for whom total bilirubin is allowed up to 3 x upper limit of normal \\[ULN\\])\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70\n* Patients must be free of uncontrolled infection\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-hematopoietic cell transplant (HCT) must have no evidence of ongoing GVHD and be off GVHD treatment immunosuppression for at least 6 weeks at time of enrollment\n* Patients must have normal elastography\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2\\* MRI\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation\n* Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Fred Hutch and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:\n\n  * Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\n  * Unrelated donor:\n\n    * Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n  * Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects\n* Left ventricular ejection fraction \\\u003C 35%\n* Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen; when pulmonary function test (PFT)s cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV)\n* Perceived inability to tolerate diagnostic or therapeutic procedures\n* Active central nervous system (CNS) leukemia at time of treatment\n* Patients with prior myeloablative allogeneic-HCT\n* Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive \\[beta-HCG+\\] or breast feeding\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant\n* Inability to understand or give an informed consent\n* Allergy to murine-based monoclonal antibodies\n* Known contraindications to radiotherapy","75 Years",{"count":107,"type":22},75,[57,25],"This phase I\u002FII trial studies the side effects and best dose of 211\\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.",[28,111,29,30,112,113,114,115,116,117,118,119],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","Myelodysplastic Syndrome With Excess Blasts","Recurrent Acute Myeloid Leukemia","Refractory Acute Lymphoblastic Leukemia","Recurrent Acute Lymphoblastic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Refractory Acute Myeloid Leukemia","Refractory Mixed Phenotype Acute Leukemia","Mixed Phenotype Acute Leukemia",{"date":65,"type":38},{"date":122,"type":38},"2017-10-24",{"date":124,"type":22},"2029-03-31",{"name":126,"class":45},"Fred Hutchinson Cancer Center",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":135,"briefSummary":136,"conditions":137,"keywords":141,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":46},"100337247","phase-1-211at-bc8-b10-followed-by-donor-stem-cell-transplant-in-treating-patients-with-relapsed-or-refractory-high-risk-acute-leukemia-or-myelodysplastic-syndrome-100337247","NCT03670966","211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome","A Phase I\u002FII Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry;\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen);\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens);\n  * AML evolved from myelodysplastic or myeloproliferative syndromes;\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria.\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow).\n* Patients must be \\>= 18 and =\\\u003C 75 years of age.\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed).\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration.\n* Total bilirubin within normal limits\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2 times the upper limit of normal.\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70.\n* Patients must be free of uncontrolled infection.\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-HCT must have no evidence of ongoing GVHD and be off all immunosuppression for at least 6 weeks at time of enrollment.\n* Patients must have normal elastography.\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2 magnetic resonance imaging (MRI).\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation.\n* Patients must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches.\n* DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) criteria for PBSC or bone marrow donation. Preference should be given to donors who are mismatched at the HLA-A, -B and -DRB1 loci.\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects.\n* Left ventricular ejection fraction \\\u003C 45%.\n* Corrected diffusion capacity of the lung for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV).\n* Perceived inability to tolerate diagnostic or therapeutic procedures.\n* Active central nervous system (CNS) leukemia at time of treatment.\n* Patients with prior myeloablative allogeneic-HCT.\n* Women of childbearing potential who are pregnant (beta human chorionic gonadotropin \\[B-HCG\\]+) or breast feeding.\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.\n* Inability to understand or give an informed consent.\n* Allergy to murine-based monoclonal antibodies.\n* Known contraindications to radiotherapy.",{"count":55,"type":22},[57,25],"This phase I\u002FII trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.",[138,111,139,30,112,115,113,114,117,116,118,140],"Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia in Remission","Hematopoietic and Lymphoid Cell Neoplasm",[142,143,144],"Lymphoid Leukemia","Myeloid and Monocytic Leukemia","Other Hematopoietic","2026-06-17",{"date":65,"type":38},{"date":148,"type":38},"2019-07-10",{"date":150,"type":22},"2029-10-20",{"name":126,"class":45},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":158,"targetDuration":160,"studyType":161,"phases":4,"briefSummary":162,"conditions":163,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":46},"100307332","relevance-of-peripheral-cells-in-the-pathophysiology-of-chronic-myelomonocytic-leukemia-cmml-100307332","NCT03280888","Relevance of Peripheral Cells in the Pathophysiology of Chronic Myelomonocytic Leukemia (CMML)","Inclusion Criteria:\n\n* Patients newly diagnosed or undergoing treatment in the Clinical Hematology department of the participating establishments\n\nExclusion Criteria:\n\n* NA",{"count":159,"type":22},50,"1 Day","OBSERVATIONAL","Chronic Myelomonocytic Leukemia (CMML) is the most frequent of myelodysplastic\u002Fmyeloproliferative syndromes, as defined by the WHO classification of myeloid malignancies. The median age at diagnosis is around 70 years with a strong male predominance. CMML is a clonal disease of the bone marrow hematopoietic stem cell mainly characterized by persistent monocytosis (\\>1x109\u002FL) and the presence of immature dysplastic granulocytes in the peripheral blood of CMML patients. Allogeneic stem cell transplantation (ASCT) remains the only curative option in CMML. However, CMML patients are rarely eligible for this kind of therapy, mainly due to their advanced age. The gold standard treatment of CMML thus remains hydroxyurea, which is usually initiated when the disease becomes proliferative, and demethylating agents, which could be efficient in the most aggressive forms of CMML. Nevertheless, the pathogenesis of CMML remains poorly understood and new therapies are urgently needed for patients in treatment failure.\n\nIn recent years, a large numbers of gene mutations have been discovered in CMML, none of which are specific of this entity, as they can be encountered with different frequencies in other myeloid neoplasms. These mutated genes encode signaling molecules (NRAS, KRAS, CBL, JAK2, FLT3 and several members of the Notch pathway), epigenetic regulators (TET2, ASXL1, EZH2, IDH1, IDH2,.) and splicing factors (SF3B1, SRSF2, ZRSF2). Mutations in the transcription regulators RUNX1, NPM1 and TP53 have also been reported in CMML. However, the role of these mutations in leukemogenesis is still unclear. CMML is also characterized by defects in monocyte to macrophage differentiation. These defects in monocyte differentiation can be attributed to the presence of immature dysplastic granulocytes that secrete high levels of alpha-defensins HNP1-3 that antagonize the purinergic receptor P2RY6 in CMML patients. These CD14-\u002FCD15+\u002FCD24+ immature granulocytes that belong to the same clone than the leukemic monocytes seem to have immunosuppressive properties ressembling those of the myeloid-derived suppressor cells (MDCS) described in solid tumours. Whether these immature granulocytes contribute to autoimmune manifestations or immunoescape and progression of CMML is a conendrum and remains to be determined.\n\nIn this context, the proposed project aims at identifying news insights into the pathophysiology of CMML through a better definition of the phenotype and function of monocytes and immature granulocytes that characterize this pathology.",[30],"2026-06-15",{"date":166,"type":38},"2026-06-16",{"date":168,"type":38},"2014-11-05",{"date":170,"type":22},"2028-11-05",{"name":172,"class":45},"Centre Hospitalier Universitaire de Nice",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":180,"targetDuration":4,"studyType":23,"phases":182,"briefSummary":184,"conditions":185,"keywords":190,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":46},"100359777","early-phase-1-hyperbaric-oxygen-therapy-and-allogeneic-peripheral-blood-stem-cell-pbsc-transplant-100359777","NCT03964506","Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant","A Pilot Study to Determine the Safety and Efficacy of Incorporating Hyperbaric Oxygen Therapy Into RIC Fludarabine and Melphalan and Allogeneic Hematopoietic Stem\u002FProgenitor Transplantation","Inclusion Criteria:\n\n* Voluntary written informed consent\n* Men or women, age ≥ 18 years of age, with upper limit of 75 years old.\n* Subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS) for cohort 1.\n* Subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), CML, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic\u002Fmyeloproliferative (MDS\u002FMPN) overlap syndrome for cohort 2.\n* Karnofsky performance status (KPS) of ≥ 70%\n* Patients should have New York Heart Association (NYHA) Functional Classification, Class I (ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain) or Class II (ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain).\n* Adequate hepatic, renal, cardiac and pulmonary function to be eligible for transplant. Minimum criteria include: Hepatic: ALT, AST \\\u003C 4x IULN and serum total bilirubin ≤ 2.0 mg\u002FdL; Renal: serum creatinine: ≤ 2.0 mg\u002FdL; Left ventricular ejection fraction ≥ 45% measured by 2D-ECHO or MUGA scan; EKG with no clinically significant arrhythmia; FEV1, FVC and DLCO ≥ 50% of predicted value (corrected to serum hemoglobin)\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days following completion of therapy. Should a woman or partner become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician and the investigator immediately.\n* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: Has not undergone a hysterectomy or bilateral oophorectomy; or Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Women of child-bearing potential should have a negative urine or serum pregnancy test within 4 weeks of starting preparative regimen\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Severe chronic obstructive pulmonary disease requiring oxygen supplementation\n* History of spontaneous pneumothorax, prior chest surgery requiring thoracotomy or direct chest irradiation to the lungs\n* Evidence of pneumothorax or significant pulmonary fibrosis on chest imaging within 60 days of transplant.\n* Active malignancy excluding AML, MDS, CMML, aCML CML, CNL, MF and MDS\u002FMPN overlap syndrome.\n* Active ear\u002Fsinus infection. Patients with chronic sinusitis or sinus headaches are excluded unless cleared by ear, nose, and throat specialist.\n* Recent sinus surgery (within the last 5 years).\n* Ear surgery excluding myringotomy or ear tubes\n* Subjects must agree to refrain from active tobacco or e-cigarette use 72 hours prior to transplant until complete transplant recovery. Nicotine replacement therapy is allowed.\n* Claustrophobia\n* History of recurrent seizures within 5 years of study enrollment.\n* Uncontrolled asthma\n* Uncontrolled viral or bacterial infection at the time of study enrollment\n* Active or recent (prior 6 months) invasive fungal infection without interdisciplinary (ID) consult and approval\n* Patients who had intrathecal chemotherapy within 2 weeks of starting preparative regimen or cranial irradiation within 4 weeks of starting preparative regimen",{"count":181,"type":22},24,[183],"EARLY_PHASE1","The purpose of this study is to determine if hyperbaric oxygen therapy is safe in the setting of stem cell transplantation. This study will also determine if hyperbaric oxygen therapy improves engraftment, graft versus host disease, neutrophil count, and incidence and severity of mucositis (inflammation of the mouth or gut) and infection. This study has two cohorts. The first cohort is subjects with acute myeloid leukemia (AML) or Myelodysplastic Syndrome (MDS). The second cohort is subjects with chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (aCML), chronic monocytic leukemia, chronic neutrophilic leukemia (CNL), myelofibrosis, and myelodysplastic\u002Fmyeloproliferative (MDS\u002FMPN) overlap syndrome. The first cohort has completed the recruitment so only the second cohort will be recruited.",[29,87,30,186,187,188,189],"Atypical Chronic Myeloid Leukemia","Chronic Monocytic Leukemia","Myelofibrosis","Myelodysplastic\u002FMyeloproliferative Neoplasm",[191,192],"Allogeneic transplant","Hyperbaric Oxygen","2026-06-01",{"date":195,"type":38},"2026-06-03",{"date":197,"type":38},"2020-07-01",{"date":199,"type":22},"2028-03-01",{"name":201,"class":45},"Omar Aljitawi",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":209,"sex":17,"minAge":210,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":46},"100377523","phase-2-donor-stem-cell-transplant-with-treosulfan-fludarabine-and-total-body-irradiation-for-the-treatment-of-hematological-malignancies-100377523","NCT04195633","Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies","Hematopoietic Stem Cell Transplantation From Haploidentical Donors in Patients With Hematological Malignancies Using a Treosulfan-Based Preparative Regimen","Inclusion Criteria:\n\n* Acute leukemia (AL) that includes acute myeloid leukemia (AML) \u002F acute lymphoblastic leukemia (ALL) \u002F mixed phenotype leukemia (MPAL) in complete morphological remission (CR) with or without detectable minimal residual disease (MRD); complete morphological remission is defined by the presence of less than 5% of detectable blasts in bone marrow specimen, evaluated per standard of care. Patients with documented CR but without hematologic recovery since last chemotherapy are considered eligible to the study\n* Chronic myelogenous leukemia (CML), except refractory blast crisis. To be eligible in first chronic phase, patients must have failed or be intolerant to at least one tyrosine-kinase inhibitor\n* Chronic myelomonocytic leukemia (CMML)\n* Myelodysplastic syndromes (MDS)\n* Lymphoblastic, Burkitt's and other high-grade lymphoma in any complete (CR) or partial (PR) response\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Low grade lymphoma (chronic lymphocytic leukemia \\[CLL\\]\u002Fsmall lymphocytic lymphoma \\[SLL\\], marginal zone lymphoma, follicular lymphoma) progressed after two treatment regimens, in CR\u002FPR\n\n  * For CLL\u002FSLL, CR and PR are defined according to: International Workshop on CLL (iwCLL) guidelines for diagnosis, indications for treatment, response assessment, and supportive management of CLL\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Large cell lymphoma in \\> second CR (CR2)\u002F \\>= PR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Mantle cell lymphoma, lymphoplasmacytic lymphoma and prolymphocytic leukemia may be eligible after initial therapy if in CR\u002FPR\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n  * For prolymphocytic leukemia (PLL), CR is defined as a normalization of lymphadenopathies (long-axis diameter \\\u003C 1 cm) and splenomegaly (\\\u003C 13 cm), absence of constitutional symptoms, PLL cells \\\u003C 5% in bone marrow and circulating lymphocytes count \\\u003C 4 x 10\\^9\u002FL. Patients without hematopoietic recovery are considered eligible to the study. PR is defined as a decrease of \\>= 30% of the sum of lymphadenopathies' long-axis diameters, a decrease of \\>= 50% in spleen vertical length beyond normal from baseline, peripheral blood (PB) lymphocytes =\\\u003C 30 x 10\\^9\u002FL (and a decrease of \\>= 50% from baseline)\n* Hodgkin Lymphoma in \\> CR2\u002FPR2\n\n  * CR and PR are defined according to Lugano classification: Recommendations for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification\n* Subjects must be \\>= 6 months old\n* Karnofsky \\>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 (for adults)\n* Lansky score \\>= 50 (for children)\n* Adequate cardiac function defined as absence of decompensated congestive heart failure or uncontrolled arrhythmia AND left ventricular ejection fraction \\>= 40% or shortening fraction \\> 22%\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and one of the following:\n\n  * Diffusion capacity of the lung for carbon monoxide (DLCO) corrected \\>= 70% mm Hg\n  * DLCO corrected between 60% - 69% mm Hg and partial pressure of oxygen (pO2) \\>= 70 mm Hg\n  * DLCO corrected between 50% - 59% mm Hg and pO2 \\>= 80 mm Hg Pediatric patients unable to perform pulmonary function tests must have O2 saturation \\>= 92% on room air. May not be on supplemental oxygen\n* Total bilirubin \\\u003C 2 x upper limit of normal (ULN) unless felt to be related to Gilbert's disease or hemolysis\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN\n* Alkaline phosphatase =\\\u003C 5 x ULN\n* Creatinine \\\u003C 2.0 mg\u002Fdl (adults) or estimated creatinine clearance \\> 40 ml\u002Fmin (pediatrics)\n\n  * All adults with a creatinine \\> 1.2 or a history of renal dysfunction must have estimated creatinine clearance \\> 40 ml\u002Fmin\n* If recent mold infection, e.g., aspergillus, must be cleared by infectious disease to proceed\n* Patients who have undergone prior allogeneic hematopoietic cell transplant are eligible, but the prior transplant must have been performed at least 3 months prior to enrollment, unless in case of graft failure from the prior transplant\n* Written and signed informed consent\n* DONOR: Donors must be haploidentical relatives of the patients. Donor-recipient compatibility will be tested through HLA typing at high resolution for the HLA loci (-A, -B, -C, -DRB1, -DQB1). Donor and recipient should share at least 5\u002F10 HLA loci\n* DONOR: Age \\>= 12 years\n* DONOR: Weight \\>= 40 Kg\n* DONOR: Ability of donors younger than 18 years of age to undergo apheresis without use of a vascular access device. Vein check must be performed and verified by an apheresis nurse prior to arrival.\n* DONOR: Donor must meet selection criteria as defined by the Foundation of the Accreditation of Cell Therapy (FACT) and will be screened per the American Association of Blood Banks (AABB) guidelines\n* DONOR: In case of more available haploidentical donors, selection criteria should include, in this order:\n\n  * For cytomegalovirus (CMV) seronegative recipients, a CMV seronegative donor\n  * Red blood cell compatibility\n\n    * Red blood cell (RBC) cross match compatible\n    * Minor ABO incompatibility\n    * Major ABO incompatibility\n\nExclusion Criteria:\n\n* Active, uncontrolled, life-threatening viral, bacterial or fungal infection requiring treatment at time of conditioning regiment administration and transplantation\n* Presence of a malignancy other than the one for which the transplant is being performed, with an expected survival less than 75% at 5 years\n* Pregnant or breastfeeding\n* Known hypersensitivity to treosulfan, fludarabine or cyclophosphamide\n* Dosing with another investigational agent within 30 days prior to entry in the study\n* Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and\u002For cranial radiation prior to initiation of conditioning (day -6)\n* DONOR: Since detection of anti-donor-specific-antigen antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patients with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study. The first 10 subjects enrolled in the trial will be DSA-negative.",true,"6 Months",{"count":212,"type":22},60,[25],"This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.",[216,28,29,217,218,219,220,30,221,222,223,224,119,32,225,226,227,228,229],"Acute Leukemia","Adult Diffuse Large Cell Lymphoma","Anaplastic Large Cell Lymphoma","Burkitt Lymphoma","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Hodgkin Lymphoma","Lymphoblastic Lymphoma","Lymphoplasmacytic Lymphoma","Mantle Cell Lymphoma","Prolymphocytic Leukemia","Refractory Chronic Lymphocytic Leukemia","Refractory Follicular Lymphoma","Refractory Marginal Zone Lymphoma","Refractory Small Lymphocytic Lymphoma","2026-05-27",{"date":232,"type":38},"2026-05-29",{"date":234,"type":38},"2021-01-25",{"date":236,"type":22},"2029-03-12",{"name":126,"class":45},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":244,"maxAge":19,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":46},"100264904","phase-2-personalized-nk-cell-therapy-in-cbt-100264904","NCT02727803","Personalized NK Cell Therapy in CBT","Inclusion Criteria:\n\n* Patients must have one of the following hematologic malignancies: acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics including complex karyotype, abnormal \\[abn\\]\\[3q\\], -5\u002F5q-, -7\u002F7q-, abn\\[12p\\], abn\\[17p\\], myeloid\u002Flymphoid or mixed-lineage leukemia \\[MLL\\] gene re-arrangement and t \\[6;9\\]47, fms related tyrosine kinase 3 \\[flt3\\] mutation positive and\u002For evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and\u002For arising from myelodysplastic syndromes (MDS), any disease beyond first remission\n* Myelodysplastic syndrome (MDS): Primary or therapy related, including patients that will be considered for transplant; these include any of the following categories: 1) revised International Prognostic Scoring System (IPSS) intermediate and high risk groups, 2) malondialdehyde (MDA) with transfusion dependency, 3) failure to respond or progression of disease on hypomethylating agents, 4) refractory anemia with excess of blasts, 5) transformation to acute leukemia, 6) chronic myelomonocytic leukemia, 7) atypical MDS\u002Fmyeloproliferative syndromes, 8) complex karyotype, abn(3g), -5\u002F5g-, -7\u002F7g-, abn(12p), abn(17p)\n* Acute lymphoblastic leukemia (ALL): Induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease; patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and\u002For evidence of minimal residual disease or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma\n* Non-Hodgkin's lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); relapsed double hit lymphomas; patients with options for treatment that are known to be curative are not eligible\n* Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease following a minimum of two lines of standard therapy\n* Chronic myeloid leukemia (CML) second chronic phase or accelerated phase\n* Hodgkin's disease (HD): Induction failures, after first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease\n* Multiple myeloma: stage II or III, symptomatic, secretory multiple myeloma requiring treatment\n* A person (such as a haploidentical family member) or unit of cord blood must be identified as a source of back-up cells source in case of engraftment failure\n* Patient age criteria: age \\>= 15 and =\\\u003C 45 years (myeloablative regimen 1; age \\>= 15 and =\\\u003C 80 years (nonmyeloablative regimen 2) at the discretion of the investigator(s); age \\>= 15 and =\\\u003C 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy may receive reduced intensity regimen 3\n* Performance score of at least 60% by Karnofsky\n* Left ventricular ejection fraction of at least 40% (myeloablative regimen 1, reduced intensity regimen 3)\n* Left ventricular ejection fraction of at least 30% (nonmyeloablative regimen 2)\n* Pulmonary function test (PFT) demonstrating an adjusted diffusion capacity of least 50% predicted value for hemoglobin concentration (myeloablative regimen 1, reduced intensity regimen 3)\n* Serum creatinine within normal range, or if serum creatinine outside normal range, then renal function (measured or estimated creatinine clearance or glomerular filtration rate \\[GFR\\]) \\> 40mL\u002Fmin\u002F1.73 m\\^2\n* Serum glutamate pyruvate transaminase (SGPT)\u002Fbilirubin \\\u003C to 2.0 x normal (myeloablative regimen 1), reduced intensity regimen 3; SGPT\u002Fbilirubin \\\u003C to 4.0 x normal (nonmyeloablative regimen 2)\n* Negative beta human chorionic gonadotropin (HCG) test in a woman with child bearing potential defined as not post-menopausal for 12 months\n* Patients with options for treatment that are known to be curative are not eligible\n* Patients enrolled in this study may be enrolled on other supportive care investigational new drug (IND) studies at the discretion of the principal investigator (PI)\n\nExclusion Criteria:\n\n* Human immunodeficiency virus (HIV) positive; HIV results will be determined by nucleic acid testing\n* Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation (excluding primary disease for which cord blood \\[CB\\] transplantation is proposed), or psychiatric condition that would limit informed consent\n* Active central nervous system (CNS) disease in patient with history of CNS malignancy\n* Availability of appropriate, willing, human leukocyte antigen (HLA)-matched related stem cell donor","15 Years",{"count":246,"type":22},100,[25],"This phase II clinical trial studies how well personalized natural killer (NK) cell therapy works after chemotherapy and umbilical cord blood transplant in treating patients with myelodysplastic syndrome, leukemia, lymphoma or multiple myeloma. This clinical trial will test cord blood (CB) selection for human leukocyte antigen (HLA)-C1\u002Fx recipients based on HLA-killer-cell immunoglobulin-like receptor (KIR) typing, and adoptive therapy with CB-derived NK cells for HLA-C2\u002FC2 patients. Natural killer cells may kill tumor cells that remain in the body after chemotherapy treatment and lessen the risk of graft versus host disease after cord blood transplant.",[250,251,28,138,252,253,254,255,30,256,257,258,259,32,112,260,189,261,113,262,263,264,114,265,266,267],"Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Biphenotypic Leukemia","Acute Myeloid Leukemia With Myelodysplasia-Related Changes","Acute Myeloid Leukemia With Variant MLL Translocations","B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1","Chemotherapy-Related Leukemia","Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","ISS Stage II Plasma Cell Myeloma","ISS Stage III Plasma Cell Myeloma","Myelodysplastic Syndrome With Gene Mutation","Previously Treated Myelodysplastic Syndrome","Recurrent Adult Acute Myeloid Leukemia","Recurrent Hodgkin Lymphoma","Recurrent Non-Hodgkin Lymphoma","Refractory Adult Acute Lymphoblastic Leukemia","Secondary Acute Myeloid Leukemia","Therapy-Related Myelodysplastic Syndrome","2026-05-20",{"date":270,"type":38},"2026-05-22",{"date":272,"type":38},"2016-05-19",{"date":274,"type":22},"2027-05-31",{"name":276,"class":45},"M.D. Anderson Cancer Center",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":46},"100380866","phase-2-a-phase-ii-open-label-study-of-subcutaneous-canakinumab-an-anti-il-1-human-monoclonal-antibody-for-patients-with-low-or-int-1-risk-ipssipss-r-myelodysplastic-syndromes-and-chronic-myelomonocytic-leukemia-100380866","NCT04239157","A Phase II, Open-Label, Study of Subcutaneous Canakinumab, an Anti-IL-1β Human Monoclonal Antibody, for Patients With Low or Int-1 Risk IPSS\u002FIPSS-R Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age ≥ 18 years as MDS and CCUS are very rare conditions in the pediatric setting.\n* Cohorts 1-3: Diagnosis of MDS according to WHO 2016 classification and low or intermediate-1 risk by IPSS or IPSS-R with a score of ≤ 3.5.\n* Cohort 4: Diagnosis of CCUS defined as:\n* Presence of a somatic pathogenic variant associated with hematological malignancy without morphological evidence of myelodysplasia\n* Variant allele fraction of greater than or equal to 2% in at least one identified somatic pathogenic variant\n* Bone marrow aspirate excluding hematological malignancy and MDS\n\n  * Presence of a cytopenia for \\>30 days. Cytopenia will be defined using accepted CHRS (Clonal Hematopoiesis Risk Score) criteria (Weeks et al, NEJM Evidence in press): ANC \\\u003C1.8 or hgb \\\u003C12 in females and \\\u003C13 in males or a platelet count of \\\u003C150.\n* Cohort 1: Participants need to have not responded to prior therapy with ESAs or hypomethylating agents (HMAs). These could include azacitidine, decitabine, SGI-110, ASTX727, or CC-486. Patients will need to have received at least 4 cycles of HMA. Participants with relapse or progression after any number of cycles of HMA by IWG 2006 criteria will also be candidates. Participants with evidence of del 5q alteration also are required to have been treated with Lenalidomide.\n* Cohort 1: Hemoglobin \\\u003C10g\u002FdL with symptomatic anemia or transfusion dependency defined as the need for prior transfusion in the past 8 weeks for a hemoglobin level less than 8g\u002Fdl.\n* Cohort 2: Transfusion dependency defined as the need for prior transfusion in the past 8 weeks of (1) at least 2 units of PRBC for a hemoglobin level less than 8g\u002Fdl or symptomatic anemia (hemoglobin \\\u003C10g\u002FdL), or (2) any platelet transfusion.\n* Participants (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study.\n* Adequate hepatic function with total bilirubin \\\u003C\u002F=3 x ULN, AST or ALT \\\u003C\u002F= 3xULN.\n* Serum creatinine clearance \\>30mL\u002Fmin and no end\u002Fstage renal disease (using Cockcroft-Gault).\n* ECOG performance status \\\u003C\u002F=2.\n\nExclusion Criteria:\n\n* Active infection not adequately responding to appropriate antibiotics.\n* Prior treatment with IL-1\u002FIL-1r inhibitors\n* Absolute neutrophil count (ANC) \\\u003C0.5x109 k\u002Ful; colony-stimulating factors can be administered prior to study drug initiation.\n* Female participants who are pregnant or lactating.\n* Participants with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives \\[birth control pills\\], contraceptive injections, intrauterine devices \\[IUD\\], double-barrier method \\[spermicidal jelly or foam with condoms or diaphragm\\], contraceptive patch, or surgical sterilization) throughout the study. Reproductive potential is defined as no previous surgical sterilization or females that are not post-menopausal for 12 months.\n* Female participants with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.\n* History of an active malignancy within the past 2 years prior to study entry, with the exception of: a. Adequately treated in situ carcinoma of the cervix uteri b. Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin or any other malignancy with a life expectancy of more than 2 years.\n* Participants receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment).\n* Known history of testing positive for Human Immunodeficiency Virus (HIV) infections.\n\nParticipants requiring systemic steroids, methotrexate or other immunosuppressive drugs will not be included in the study.",{"count":284,"type":22},76,[25],"This phase II trial studies how well canakinumab works for the treatment of low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Canakinumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.",[30,32,288,289,290,291],"Recurrent Chronic Myelomonocytic Leukemia","Recurrent Myelodysplastic Syndrome","Refractory Chronic Myelomonocytic Leukemia","Refractory Myelodysplastic Syndrome","2026-05-18",{"date":268,"type":38},{"date":295,"type":38},"2020-08-25",{"date":297,"type":22},"2026-12-31",{"name":276,"class":45},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":19,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":324,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":46},"100310864","phase-1-ha-1-t-tcr-t-cell-immunotherapy-for-the-treatment-of-patients-with-relapsed-or-refractory-acute-leukemia-after-donor-stem-cell-transplant-100310864","NCT03326921","HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant","Phase I Study of Adoptive Immunotherapy With CD8+ and CD4+ Memory T Cells Transduced to Express an HA-1-Specific T Cell Receptor (TCR) for Children and Adults With Recurrent Acute Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation (HCT)","Inclusion Criteria:\n\n* Subject age 0-80 years at the time of enrollment.\n* Subject must express HLA-A\\*0201\n* Subject must have the HA-1(H) genotype (RS\\_1801284: A\u002FG, A\u002FA)\n* Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either:\n\n  * HLA-A\\*0201 positive and HA-1(H) negative (RS\\_1801284: G\u002FG) or\n  * HLA-A\\*0201 negative\n* Subjects who are currently undergoing or who previously underwent allogeneic HCT for\n\n  * Acute myeloid leukemia (AML) of any subtype\n  * Acute lymphoid leukemia (ALL) of any subtype\n  * Mixed phenotype\u002Fundifferentiated\u002Fany other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm\n  * Chronic myeloid leukemia with a history of blast crisis and:\n\n    * With relapse or refractory disease (\\>= 5% marrow blasts, or circulating blasts) at any time after HCT\n    * With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \\\u003C 5% marrow blasts by morphology, no circulating blasts on \\>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT\n  * Myelodysplastic syndrome (MDS) of any subtype\n  * Chronic myelomonocytic leukemia (CMML)\n  * Juvenile myelomonocytic leukemia (JMML)\n* Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old\n* Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion\n* Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol\n* A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status\n\nDONOR SELECTION INCLUSION\n\n* Donor age \\>= 18 years\n* Donors must be able to give informed consent\n\nExclusion Criteria:\n\n* Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)\n* Fertile subjects unwilling to use contraception during and for 12 months after treatment\n* Subjects with a life expectancy of \\\u003C 3 months of enrollment from coexisting disease other than leukemia\n* Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and\u002For sustained significant improvement in GVHD severity\n* The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required\n\nDONOR SELECTION EXCLUSION\n\n* Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection\n* Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP",{"count":181,"type":22},[57],"This phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.",[310,311,312,313,314,114,265,315,316,289,317,291,318,119,319,320,115,113,32,29,28,251,321,30,322,288,116,323,220],"Juvenile Myelomonocytic Leukemia","Recurrent Acute Biphenotypic Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Childhood Acute Lymphoblastic Leukemia","Recurrent Childhood Acute Myeloid Leukemia","Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Undifferentiated Leukemia","Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive","Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Myeloid Leukemia","Minimal Residual Disease","Leukemia",[325,326,327,323],"HA-1","TCR","Immunotherapy","2026-05-15",{"date":292,"type":38},{"date":331,"type":38},"2018-02-23",{"date":333,"type":22},"2028-07-16",{"name":126,"class":45},{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":342,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":348,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":46},"100628997","phase-2-ropeginterferon-alfa-2b-for-the-treatment-of-myelodysplastic-syndromemyeloproliferative-neoplasm-overlap-syndromes-and-chronic-myelomonocytic-leukemia-100628997","NCT07468916","Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome\u002FMyeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia","Ropeginterferon Alfa-2b for MDS\u002FMPN Overlap Syndromes, Including CMML and MDS\u002FMPN-RS-T","Inclusion Criteria:\n\n* Male or female ≥ 18 years of age at time of consent\n* Documentation of a diagnosis of MDS\u002FMPN overlap syndrome based on World Health Organization (WHO) 2022 classification, including CMML, MDS\u002FMPN with neutrophilia, myelodysplastic\u002Fmyeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS\u002FMPN-RS-T), or MDS\u002FMPN, not otherwise specified, by local pathology review, and deemed to potentially benefit from study participation by the investigator\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study\n* Blast =\\\u003C 10% by marrow immunohistochemistry stain\n* Platelet count of \\> 50,000\u002FuL\n* Absolute neutrophils count (ANC) of \\> 1000\u002FuL\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\\\u003C 2\n* Serum creatinine =\\\u003C 2.5 mg\u002FdL\n* Serum direct bilirubin \\\u003C 2.0 mg\u002FdL\n* Serum transaminase \\\u003C 2.5 times the upper limit of the normal range (ULN) or \\\u003C 5 times ULN if the transaminase elevation was deemed related to the MDS\u002FMPN\n\nExclusion Criteria:\n\n* Prior therapy with interferon or pegylated interferon product, or azacitidine\n* Spleen overtly enlarged by physical exam (eg. greater than 5 fingerbreadth below costal margin)\n* Other standard (including erythropoietin-stimulating agents \\[ESA\\] or luspatercept) or experimental therapy for MDS\u002FMPN within 28 days of starting study therapy with the exception of hydroxyurea, which is allowed to continue up to 28 days after cycle 1 day 1 (C1D1) while on protocol\n* Clinically significant autoimmune disease by investigator assessment, regardless if the autoimmune phenomena is related to MDS\u002FMPN overlap syndrome\n* History of or current clinically relevant depression or anxiety per investigator's judgement. Previous suicidal ideation or attempts are not allowed to participate in interferon (IFN) therapy\n* Evidence of severe retinopathy or clinically relevant ophthalmological disorder\n* History of organ transplant\n* Pregnant or breastfeeding women\n* Active uncontrolled infection with clinical symptoms, e.g., presence of bacteria, fungal, human immunodeficiency virus (HIV), hepatitis B or C\n* Active uncontrolled thromboembolic complications or hemorrhage\n* History of any malignancy within 5 years (except adequately treated non-melanoma skin cancer, prostate cancer status post resection with an undetectable prostate-specific antigen \\[PSA\\], curative treated in-situ cancer of the cervix, ductal carcinoma in situ \\[DCIS\\] of the breast, stage 1 grade 1 endometrial carcinoma, or other solid tumors including lymphomas curatively treated with no evidence of disease for ≥ 1 year prior to study)\n* Uncontrolled active clinically significant illness that, in the investigator's opinion, may affect the patient's participation in this study\n* Active abuse of alcohol and\u002For illicit drugs",{"count":21,"type":22},[25],"This phase II trial tests the safety, best dose, and effectiveness of ropeginterferon alfa-2b for the treatment of patients with myelodysplastic syndrome\u002Fmyeloproliferative neoplasm overlap syndromes and chronic myelomonocytic leukemia. Ropeginterferon alfa-2b is a form of interferon. Interferons are a type of signaling protein normally produced by the body as part of the immune response. Interferons interfere with the division of cancer cells and can slow cancer cell growth. Ropeginterferon alfa-2b is a long-acting form of a type of interferon called interferon alfa-2b. In the body, ropeginterferon alfa-2b causes the production of proteins that modulate the immune system and have anticancer effects.",[186,30,189,346,347],"Myelodysplastic\u002FMyeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Not Otherwise Specified","Myelodysplastic\u002FMyeloproliferative Neoplasm, Not Otherwise Specified","NOT_YET_RECRUITING","2026-05-05",{"date":351,"type":38},"2026-05-06",{"date":353,"type":22},"2026-09-29",{"date":355,"type":22},"2032-09-30",{"name":357,"class":45},"Jonsson Comprehensive Cancer Center",{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":366,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":370,"briefSummary":371,"conditions":372,"keywords":376,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100430719","phase-2-methods-of-t-cell-depletion-trial-motd-100430719","NCT04888741","Methods of T Cell Depletion Trial (MoTD)","A Multi-centre Phase II Trial of GVHD Prophylaxis Following Unrelated Donor Stem Cell Transplantation Comparing Thymoglobulin vs. Calcineurin Inhibitor or Sirolimus-based Post-transplant Cyclophosphamide","MoTD","Inclusion Criteria:\n\n* Availability of suitably matched unrelated donor (9\u002F10 or 10\u002F10)\n* Planned to receive one of the following RIC protocols:\n\n  * Fludarabine-Melphalan (Fludarabine 120-180mg\u002Fm2 IV; melphalan ≤ 150mg\u002Fm2 IV)\n  * BEAM or LEAM (carmustine 300mg\u002Fm2 IV or lomustine 200mg\u002Fm2 IV with: etoposide 800 mg\u002Fm2 IV; cytarabine 1600mg\u002Fm2 IV; melphalan 140mg\u002Fm2 IV)\n  * Fludarabine-Busulphan (Fludarabine 120-180mg\u002Fm2 IV; Busulphan ≤ 8mg\u002Fkg PO or 6.4mg\u002Fkg IV)\n  * Fludarabine- Treosulfan (Fludarabine 150mg\u002Fm2 IV; Treosulfan 30g\u002Fm2 IV)\n* Planned use of PBSCs for transplantation\n* Planned allo-SCT for one of the following haematological malignancies:\n\n  * AML in CR (patients enrolled onto the COSI trial are not eligible for this study)\n  * ALL in CR (patients enrolled onto the ALL-RIC trial are not eligible for this study)\n  * CMML \\\u003C10% blasts\n  * MDS \\\u003C10% blasts (patients enrolled onto the COSI trial are not eligible for this study)\n  * NHL in CR\u002FPR\n  * HL in CR\u002FPR\n  * MM in CR\u002FPR\n  * CLL in CR\u002FPR\n  * CML in 1st or 2nd chronic phase\n  * Myelofibrosis\n* Age 16-70 years\n* Females of and male patients of reproductive potential (i.e., not post-menopausal or surgically sterilised) must agree to use appropriate, highly effective, contraception from the point of commencing therapy until 12 months after transplant\n\nExclusion Criteria:\n\n* Use of any method of graft manipulation (excluding storage of future DLI)\n* Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined\n* Known hypersensitivity to study drugs or history of hypersensitivity to rabbits\n* Pregnant or lactating women\n* Adults of reproductive potential not willing to use appropriate, highly effective, contraception during the specified period\n* Life expectancy \\\u003C8 weeks\n* Active HBV or HCV infection\n* Organ dysfunction defined as:\n\n  * LVEF \\\u003C45%\n  * GFR \\\u003C50ml\u002Fmin\n  * Bilirubin \\>50µmol\u002Fl\n  * AST\u002FALT\\>3 x ULN\n* Participation in COSI or ALL-RIC trials\n* Contraindication to treatment with the study drugs (Thymoglobulin, cyclophosphamide, sirolimus, ciclosporin and mycophenolate mofetil) as detailed in each study drug SPC.\n* Patient has any other systemic dysfunction (e.g., gastrointestinal, renal, respiratory, cardiovascular) or significant disorder which, in the opinion of the investigator would jeopardise the safety of the patient by taking part in the trial.","16 Years","70 Years",{"count":369,"type":22},400,[25],"A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide.",[29,28,30,87,373,221,374,375,188],"Non Hodgkin Lymphoma","Multiple Myeloma","Chronic Myelogenous Leukemia",[377,378,379,380,381,382,383,384,385,386,387,388,389],"GvHD","Allogeneic Stem Cell Transplant","AML","MDS","CML","CMML","NHL","HL","Cyclophosphamide","Thymoglobulin","Cyclosporin","Sirolimus","Mycophenolate Mofetil","2026-04-29",{"date":349,"type":38},{"date":393,"type":38},"2021-02-22",{"date":395,"type":22},"2027-08-23",{"name":397,"class":45},"University of Birmingham",17,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":406,"targetDuration":4,"studyType":23,"phases":408,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":429,"leadSponsor":431,"locationsCount":433},"100382183","phase-2-a-multi-phase-study-of-astx030-azacitidine-and-cedazuridine-in-myeloid-neoplasm-alone-or-in-combination-with-venetoclax-in-aml-aztound-study-100382183","NCT04256317","A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)","A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects With Myeloid Neoplasm or in Combination With Venetoclax in Subjects With AML (AZTOUND Study)","Inclusion Criteria:\n\n* Phase 2 Monotherapy:\n\n  1\\. Has Confirmed MDS, CMML, or other MDS\u002FMPN diagnosis who are candidates to receive and benefit from single agent azacitidine and as applicable according to local country approvals and\u002For local institution standard practice.\n* Phase 3 Monotherapy:\n\n  1. Has confirmed MDS or CMML and is a candidate to receive and benefit from single agent azacitidine as applicable according to local country approvals and\u002For local institution standard practice:\n\n     a) French-American-British myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and CMML or MDS with intermediate-2 or high risk MDS according to the International Prognostic Scoring System (IPSS).\n  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n  3. Participants with adequate organ function.\n  4. For participants with prior allogeneic stem cell transplant, no evidence of graft-versus-host disease (GVHD).\n  5. Participants with no major surgery within 3 weeks before first study treatment.\n  6. Participants with no cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before first study treatment.\n  7. Is able to swallow the number of tablets\u002Fcapsules required for the treatment assignment within a 10-minute period and tolerate 4 hours of fasting.\n  8. Participants with projected life expectancy of at least 12 weeks.\n* Phase 1 and Phase 2 Combination Therapy:\n\n  1. Has histological confirmation of newly diagnosed AML by World Health Organization (WHO) 2022 criteria (Phase 1) or 2016 criteria (Phase 2).\n  2. Participants with projected life expectancy of at least 12 weeks.\n  3. Must be considered ineligible for intensive induction chemotherapy defined by the following:\n\n     a. Aged 75 years or older, or b. Aged 18 to 74 years with at least one of the following comorbidities: i. Severe cardiac disorder (e.g., congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).\n\n     ii. Severe pulmonary disorder (e.g., diffusing capacity of the lung for carbon monoxide (DLCO) ≤65% or forced expiratory volume in 1 second \\[FEV1\\] ≤65%). iii. Creatinine clearance ≥30 mL\u002Fmin to \\\u003C45 mL\u002Fmin. iv. Moderate hepatic impairment with total bilirubin \\>1.5 to ≤3.0 × upper limit of normal (ULN).\n\n     v. ECOG Performance Status of 2 or 3.\n  4. Has an ECOG Performance Status of 0-2 for participants ≥75 years of age or 0-3 for participants 18 to 74 years of age.\n\nExclusion Criteria:\n\n* All Monotherapy Phases:\n\n  1. Has an active uncontrolled gastric or duodenal ulcer.\n  2. Has poor medical risk because of other conditions.\n  3. Has known human immunodeficiency virus (HIV) infection.\n  4. Is known to be positive for Hepatitis B or C infection.\n  5. Has a life-threatening illness.\n  6. Has a history of other malignancies prior to study entry, with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected or adequately treated and controlled with other modalities; and any early stage malignancy for which no definitive therapy is required.\n  7. Participants with MDS\u002FMPN including CMML who have clinical extramedullary disease including clinically palpable hepatomegaly or splenomegaly.\n  8. Has previous treatment with more than 1 cycle of decitabine, azacitidine, or guadecitabine (Phases 2 and 3 only).\n  9. Has been treated with any investigational drug or therapy within 2 weeks, or 5 half-lives, whichever is longer, before the protocol-defined first dose of study treatment, or ongoing clinically significant adverse events from previous treatment with investigational drug or therapy.\n  10. Has a known or suspected hypersensitivity to cedazuridine or azacitidine or any of their excipients.\n  11. Cannot discontinue treatment with any drugs that delay gastric emptying such as glucagon-like peptide-1 (GLP-1) and\u002For gastric inhibitory polypeptide (GIP) agonists in Cycles 1 and 2 of the study.\n  12. Has a known or suspected hypersensitivity to cedazuridine or azacitidine or any of their excipients.\n* Phase 1 and Phase 2 Combination Therapy:\n\n  1. Has a history of MPN including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation.\n  2. Has the following karyotype abnormalities: t(15;17) or other acute promyelocytic leukemia variants that remain sensitive to all-trans retinoic acid (ATRA) therapy \\[t(8;21) and inv(16) are excluded in Phase 2 only\\].\n  3. Has known active central nervous system involvement from AML.\n  4. Has known human immunodeficiency virus (HIV) infection.\n  5. Is known to be positive for Hepatitis B or C infection.\n  6. Has severe hepatic impairment\n  7. Has severe renal impairment\n  8. Has a malabsorption syndrome or other condition that precludes enteral route of administration.\n  9. Has a cardiovascular disability status of New York Heart Association Class \\>2.\n  10. Has significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular, or pulmonary disease; or any other medical condition that in the opinion of the investigator would adversely affect his\u002Fher participation in this study.\n  11. Has clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal).\n  12. Has a history of other malignancies prior to study entry with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or adequately treated and controlled with other modalities); and any early stage malignancy for which no definitive therapy is required.\n  13. Has a WBC count \\>25,000\u002F microliters (μL) (hydroxyurea treatment is permitted to meet this criterion).\n  14. Has received treatment with any of the following:\n\n      1. A hypomethylating agent (azacitidine or decitabine) or venetoclax, including prior treatment for MDS.\n      2. Chimeric Antigen Receptor (CAR)-T cell therapy.\n      3. Investigational therapies for MDS or AML.\n  15. Cannot discontinue treatment with any of the following:\n\n      1. Prophylactic antifungal therapy with CYP3A inhibitor activity or other concomitant medications with moderate or strong CYP3A inhibitor activity ≥7 days or 5 halflives, whichever is greater, prior to Cycle 1 Day 1 (C1D1).\n      2. Drugs that are strong CYP3A or P-gp inhibitors ≥7 days or 5 half-lives, whichever is greater, prior to C1D1.\n  16. Cannot avoid concomitant drugs known as moderate or strong CYP3A inducers.\n  17. Cannot discontinue treatment with any drugs that delay gastric emptying such as GLP-1 and\u002For GIP agonists in Cycles 1 and 2 of the study.\n  18. Is participating in another research study requiring interventions such as drug therapy or study procedures.\n  19. Has a known or suspected hypersensitivity to cedazuridine, azacitidine, venetoclax, or any of their excipients.\n  20. Has known significant mental illness or other conditions such as alcohol or other substance abuse or addictions\n  21. Consumes grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or starfruit ≤7 days prior to C1D1.",{"count":407,"type":22},316,[25,409],"PHASE3","Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML.\n\nThe duration of this multi-phase study is approximately 8 years.",[87,29,412,30],"Myelodysplastic Syndrome\u002FNeoplasm",[414,415,416,323,417,418,419,420,421,422,423,424],"ASTX030","Myeloid Neoplasm","Hematologic Disease","Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome (MDS)","Chronic Myelomonocytic Leukemia (CMML)","Vidaza™","Azacitidine","Azacitidine and cedazuridine drug combination","Venetoclax","Venclexta™",{"date":426,"type":38},"2026-04-30",{"date":428,"type":38},"2020-05-21",{"date":430,"type":22},"2028-11-01",{"name":432,"class":96},"Taiho Oncology, Inc.",71,{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":442,"enrollmentInfo":443,"targetDuration":4,"studyType":161,"phases":4,"briefSummary":444,"conditions":445,"keywords":446,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":46},"100549834","biological-prospective-study-evaluating-the-dosage-of-plasma-cytokines-including-the-flt3-ligand-and-il6-of-patients-treated-with-non-intensive-chemotherapy-100549834","NCT06439199","Biological, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 Ligand and IL6 of Patients Treated With Non-intensive Chemotherapy","Single-center, Biological, Uncontrolled, Prospective Study Evaluating the Dosage of Plasma Cytokines Including the FLT3 (FMS-like Tyrosine Kinase 3) Ligand and IL6 With a View to Making a First Estimate of Their Prognostic Value on the Outcome of Patients Treated With Non-intensive Chemotherapy Such as Azacytidine for Acute Myelogenous Leukemia (AML), High Risk Myelodysplastic Syndrome (HR-MDS) or Chronic Myelomonocytic Leukemia (CMML)","CYTOK-AZA","Inclusion Criteria :\n\n* Age \\>=18 years\n* AML or SMD-HR or CMML in first line or in relapse receiving a hypomethylating agent +\u002F- another molecule or a hypomethylating agent in combination with venetoclax +\u002F- another molecule.\n* Patient having agreed to participate in the study (information note signature) and having signed the biocollection consent\n\nExclusion Criteria :\n\n* No social security or any other regime\n* Pregnant women or patient unable to take contraception in case of fertility\n* Breastfeeding women\n* Minors\n* Adults under guardianship, curators or safeguard of justice","99 Years",{"count":212,"type":22},"There are 2 possible treatments for the treatment of Acute Myelogenous Leukemia (AML), high-risk myelodysplastic syndromes (HR-MDS) or chronic myelomonocytic leukemia (CMML): intensive curative chemotherapy , and for over-aged or co-morbid patients , non-intensive palliative chemotherapy with a hypomethylating agent (Azacytidine) associated or not with venetoclax.\n\nPro-inflammatory cytokines and in particular IL-6 (Interleukin 6) seem to play a key role in the chemoresistance of solid cancers and AML : it would be associated with a poor prognosis of AML , would promote the proliferation of leukemic blasts , and would promote the progression of MDS to AML .\n\nIn AML treated with intensive chemotherapy, researchers demonstrated that a particular kinetic profile of the FLT3 ligand and IL6 at day 22 could very significantly predict the survival of patients with AML .\n\nIt therefore seems interesting to study the plasma cytokine profiles in patients with AML, HR-MDS or CMML treated non-intensively, and to see if researchers observe the same prognostic correlation as during intensive chemotherapy.",[29,87,30],[447,448,449,379,382,450,451],"Cytokine","IL 6","FLT3 Ligand","HR MDS","Azacytidine","2026-04-13",{"date":454,"type":38},"2026-04-16",{"date":456,"type":38},"2024-09-23",{"date":458,"type":22},"2026-12-15",{"name":460,"class":45},"Nantes University Hospital",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":4,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":23,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":478,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":74},"100317852","phase-2-ascorbic-acid-and-chemotherapy-for-the-treatment-of-relapsed-or-refractory-lymphoma-ccus-and-chronic-myelomonocytic-leukemia-100317852","NCT03418038","Ascorbic Acid and Chemotherapy for the Treatment of Relapsed or Refractory Lymphoma, CCUS, and Chronic Myelomonocytic Leukemia","Phase2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed\u002F Refractory Lymphoma, Patients With Clonal Cytopenia of Undetermined Significance, and Chronic Myelomonocytic Leukemia","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Biopsy-proven relapsed or refractory lymphomas; relapsed is defined as a relapse that occurred after having a response to the last therapy that lasted \\> 6 months; refractory is no response or relapse within 6 months; previous biopsies \\\u003C 6 months prior to treatment on this protocol will be acceptable\n\n  * NOTE: Arms A\u002FB - relapsed or refractory DLBCL within 24 months from the end of anthracycline-based therapy; no prior salvage therapy; patients can have received radiation therapy as part of initial treatment but not specifically for relapse\n  * NOTE: Arm C patients include relapsed or refractory lymphoma patients of any type for which the recommended treatment includes one of the platinum-based regimens; of note, relapsed or refractory double-hit high grade lymphoma patients and relapsed or refractory Hodgkin lymphoma patients will be enrolled in Arm C; there is no limit on the number of prior therapies for Arm C patients; the patient must be eligible for a platinum-based regimen and must not have received the same regimen in the past without responding\n* Measurable or assessable disease: measurable disease is defined as measurable by computed tomography (CT) \\[dedicated CT or the CT portion of a positron emission tomography (PET)\u002FCT\\] or magnetic resonance imaging (MRI): to be considered measurable, there must be at least one lesion that has a single diameter of \\>= 1.5 cm\n\n  * NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler; patients with assessable disease by PET are also eligible as long as the assessable disease is biopsy proven lymphoma\n* Arms A\u002FB - eligible for treatment with ifosfamide, carboplatin, and etoposide (+\u002F- rituximab)\n* Arm C eligible for treatment with one of the following standard, every 3 week, platinum-based salvage regimens (with or without monoclonal antibody as appropriate for the disease):\n\n  * Ifosfamide\u002Fcarboplatin\u002Fetoposide (ICE) or rituximab\u002Fifosfamide\u002Fcarboplatin\u002Fetoposide (RICE);\n  * Cisplatin, cytarabine (cytosine arabinoside), dexamethasone (DHAP) or RDHAP;\n  * Gemcitabine hydrochloride (gemcitabine), dexamethasone, cisplatin (GDP) or rituximab, gemcitabine, dexamethasone, cisplatin (RGDP);\n  * Gemcitabine and oxaliplatin (GemOx) or rituximab, gemcitabine and oxaliplatin (RGemOx);\n  * Oxaliplatin, cytosine arabinoside, dexamethasone (OAD) or rituximab, oxaliplatin, cytosine arabinoside, dexamethasone (ROAD)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin \\>= 8.0 g\u002FdL (may transfuse to meet this requirement), obtained =\\\u003C 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3, obtained =\\\u003C 14 days prior to registration\n* Platelet count \\>= 75000\u002Fmm\\^3, obtained =\\\u003C 14 days prior to registration\n* Total bilirubin =\\\u003C 2 x upper limit of normal (ULN) (if \\> 2 x ULN direct bilirubin is required and should be =\\\u003C 1.5 x ULN), obtained =\\\u003C 14 days prior to registration\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement), obtained =\\\u003C 14 days prior to registration\n* Creatinine =\\\u003C 1.6 mg\u002FdL; if over 1.6 then the calculated creatinine clearance must be \\>= 55 ml\u002Fmin using the Cockcroft-Gault formula, obtained =\\\u003C 7 days prior to registration\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Human immunodeficiency virus (HIV) test done =\\\u003C 14 days prior to registration\n\n  * If positive, the CD4 count must be \\> 400\n* Provide written informed consent\n* Willingness to have a central venous line \\[peripherally inserted central catheter (PICC) or PORT\\]\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n* ARM D: Patients who had a diagnosis of CCUS with one or more TET2 mutations or TET2 mutations with concurrent splicing genes mutations (SRSF2, U2AF1, SF3B1, and ZRSR2) or epigenetic regulator mutations (DNMT3A, EZH2, IDH1, IDH2). CCUS diagnosis being defined based on the absence of definitive morphologic evidence of hematologic neoplasms from bone marrow biopsy evaluation combined with evidence of pathogenic myeloid somatic mutation with a variant allele frequency (VAF) of at least 2% using our institution's next generation sequencing (NGS) panel (OncoHeme, Mayo Clinic)\n* ARM D: ECOG performance status (PS) 0, 1 or 2\n* ARM D: Patients must meet at least 1 of these 3 laboratory criteria to be enrolled:\n\n  * Hemoglobin =\\\u003C 10g\u002FdL (obtained =\\\u003C 7 days prior to registration)\n  * Absolute neutrophil count (ANC) =\\\u003C 1000\u002Fmm\\^3 (obtained =\\\u003C 7 days prior to registration)\n  * Platelet count =\\\u003C 100,000\u002Fmm\\^ 3 (obtained =\\\u003C 7 days prior to registration)\n* ARM D: Total bilirubin =\\\u003C 2 x ULN (if \\> 2 x ULN direct bilirubin is required and should be =\\\u003C 1.5 x ULN) (obtained =\\\u003C7 days prior to registration)\n* ARM D: Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (=\\\u003C 5 x ULN for patients with liver involvement) (obtained =\\\u003C7 days prior to registration)\n* ARM D: Creatinine =\\\u003C 1.6 mg\u002FdL (obtained =\\\u003C7 days prior to registration). If \\> 1.6, then the Calculated creatinine clearance must be \\>= 55 ml\u002Fmin using the Cockcroft-Gault formula\n* ARM D: Negative pregnancy test, for persons of childbearing potential only (obtained =\\\u003C 7 days prior to registration). NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* ARM D: Provide written informed consent\n* ARM D: Willingness to have a central venous line (PICC or PORT)\n* ARM D: Willingness to provide mandatory blood specimens for correlative research\n* ARM D: Willingness to return to enrolling institution (MCR) for follow-up (during the active monitoring phase of the study)\n* ARM D: Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n* ARM E PRE-REGISTRATION: Age ≥ 18 years\n* ARM E PRE-REGISTRATION: New or an established diagnosis of 2016 World Health Organization (WHO) defined chronic myelomonocytic leukemia with a somatic TET2, IDH1, or IDH2 mutation requiring treatment with DNA methyltransferase inhibitors\u002Fhypomethylating agents\n* ARM E PRE-REGISTRATION: No prior CMML directed therapy.\n\n  * Exception: Received ≤ 1 cycle of azacitidine, decitabine, erythropoiesis stimulating agent therapy (ESA), or oral decitabine and cedazuridine. NOTE: Prior exposure to hydroxyurea is allowed. Continuation beyond the first cycle must be discussed with the principal investigator (PI)\n* ARM E PRE-REGISTRATION: Creatinine ≤ 1.6 mg\u002FdL. If \\> 1.6, then the Calculated creatinine clearance must be ≥ 55 ml\u002Fmin using the Cockcroft-Gault formula\n* ARM E PRE-REGISTRATION: Willingness to provide mandatory research bone marrow sample for correlative research\n* ARM E PRE-REGISTRATION: ECOG performance status (PS) 0, 1, or 2\n* ARM E PRE-REGISTRATION: Provide written informed consent\n* ARM E REGISTRATION: Willingness to provide mandatory blood specimens for correlative research\n* ARM E REGISTRATION: Willingness to return to enrolling institution (MCR) for follow-up (during the active monitoring phase of the study)\n* ARM E REGISTRATION: Recovered to grade 1 or baseline or established as sequelae from all toxic effects of previous therapy except alopecia\n* ARM E REGISTRATION: Absolute neutrophil count (ANC) ≥ 500\u002Fmm\\^3 (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Platelet count ≥ 20,000\u002Fmm\\^3 (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Total bilirubin ≤ 1.5 x ULN ( ≤ 3 x ULN for patients with Gilbert's syndrome) (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (obtained ≤ 7 days prior to registration)\n* ARM E REGISTRATION: Ability to complete questionnaire by themselves or with assistance\n* ARM E REGISTRATION: For a person of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study. Adequate contraception is defined as follows:\n\n  * Complete true abstinence\n  * Consistent and correct use of one of the following methods of birth control:\n\n    * Male partner who is sterile prior to the female patient's entry into the study and is the sole sexual partner for that female patient\n    * Implants of levonorgestrel\n    * Injectable progestogen\n    * Intrauterine device (IUD) with a documented failure rate of less than 1% per year\n    * Oral contraceptive pill (either combined or progesterone only)\n    * Barrier method, for example: diaphragm with spermicide or condom with spermicide in combination with either implants of levonorgestrel or injectable progestogen\n* ARM E REGISTRATION: WOCBP must have a negative serum or urine pregnancy test ≤ 7 days prior to registration. NOTE: WOCBP include any person who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea \\> 12 consecutive months); or women on hormone replacement therapy with documented serum follicle stimulating hormone (FSH) level \\> 35 mIU\u002FmL. Even women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an IUD or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), must be considered to be of child-bearing potential. NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* ARM E REGISTRATION: Persons who are able to father a child must use contraception during the study and for 3 months after the last treatment dose.\n\n  * Complete true abstinence\n  * Latex condom with a spermicidal agent\n  * Diaphragm with spermicide\n* ARM E REGISTRATION: Willingness to have a central venous line (PICC or PORT)\n* ARM E REGISTRATION: Willingness to follow the requirements of the intravenous ascorbic acid program schedule\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Any therapy =\\\u003C 2 weeks prior to registration; NOTE: Exception: patients on ibrutinib or corticosteroids (any dose) may continue therapy up until the new regimen has started at investigator discretion; corticosteroids can be tapered to lowest possible dose after start of treatment at investigator discretion. Exception: Palliative radiation is allowed\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pulmonary congestion or pulmonary edema, clinical dehydration, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Receiving any other investigational agent which would be considered as a treatment for the lymphoma\n* Other active malignancy than lymphoma\n\n  * NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer that could interfere with this protocol therapy; patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria; patients with non-melanotic skin cancer may enroll\n* History of myocardial infarction =\\\u003C 6 months, or current symptomatic congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* Patients with active central nervous system (CNS) lymphoma or active cerebrospinal fluid (CSF) involvement with malignant cells requiring CNS-specific therapy with IV or intrathecal (IT) methotrexate (MTX); Note: Patients with any prior CNS lymphoma (parenchymal or leptomeningeal) MUST be in complete remission (CR) in those compartments without any maintenance therapy required\n* Patients with uncontrolled or symptomatic kidney stones\n* Known paroxysmal nocturnal hemoglobinuria (PNH)\n* ARM D: Bona-fide hematological neoplasm\n* ARM D: Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* ARM D: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* ARM D: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, pulmonary congestion or pulmonary edema, clinical dehydration, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* ARM D: History of myocardial infarction =\\\u003C 6 months, or current symptomatic congestive heart failure or known LVEF \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* ARM D: Patients with uncontrolled or symptomatic kidney stones\n* ARM D: Known paroxysmal nocturnal hemoglobinuria (PNH)\n* ARM D: Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* ARM E PRE-REGISTRATION: Myelodysplastic syndrome (MDS)\u002Fmyeloproliferative neoplasm (MPN) overlap syndromes other than CMML\n* ARM E PRE-REGISTRATION: Active central nervous system disease\n* ARM E PRE-REGISTRATION: Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug\n* ARM E PRE-REGISTRATION: Concurrent active malignancy, except adequately treated nonmelanoma skin cancer. History of curatively treated in situ cancer of the cervix, curatively treated in situ cancer of the breast, or other solid tumors curatively treated is allowed as long as there is no evidence of disease for \\> 2 years\n* ARM E PRE-REGISTRATION: Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* ARM E PRE-REGISTRATION: Disease requiring systemic treatment with systemic immunosuppression with steroid steroids at a dose of ≥ 20 mg\u002Fday prednisone (or equivalent). Exceptions: Intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids\n* ARM E PRE-REGISTRATION: Patients with uncontrolled or symptomatic kidney stones\n* ARM E REGISTRATION: New York Heart Association (NYHA) class III\u002FIV heart failure or active angina\u002Fangina equivalents\n* ARM E REGISTRATION: History of myocardial infarction ≤ 6 months, or current symptomatic congestive heart failure or known LVEF \\\u003C 40% or with \\> grade 2 diastolic dysfunction, with no symptoms or signs of heart failure\n* ARM E REGISTRATION: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, clinically significant cardiac arrhythmia, unstable angina pectoris, clinically significant nonhealing or healing wounds, pulmonary congestion or pulmonary edema, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection, clinical dehydration, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* ARM E REGISTRATION: Known G6PD (glucose-6-phosphate dehydrogenase) deficiency (below lower limit of normal)\n* ARM E REGISTRATION: Any of the following because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception",{"count":469,"type":22},80,[25],"This phase II trial studies the effect of ascorbic acid and combination chemotherapy in treating patients with lymphoma that has come back (recurrent) or does not respond to therapy (refractory), clonal cytopenia of undetermined significance and chronic myelomonocytic leukemia (CMML). Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ascorbic acid and combination chemotherapy may kill more cancer cells.\n\nArms A, B, C, and D are closed to enrollment.",[473,257,474,263,475,476,477,30],"Clonal Cytopenia of Undetermined Significance","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Lymphoma",{"date":454,"type":38},{"date":480,"type":38},"2018-03-23",{"date":482,"type":22},"2033-11-02",{"name":484,"class":45},"Mayo Clinic",{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":23,"phases":496,"briefSummary":497,"conditions":498,"keywords":501,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":46},"100598412","early-phase-1-momelotinib-in-combination-with-hypomethylating-agent-for-chronic-phase-myelodysplastic-syndromesmyeloproliferative-overlap-neoplasms-and-chronic-neutrophilic-leukemia-100598412","NCT07071155","Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes\u002FMyeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia","A Pilot Study of Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes\u002FMyeloproliferative Overlap Neoplasms and Chronic Neutrophilic Leukemia (M-HArbOr)","M-HArbOr","* Patients of age 18 or older\n* Has a diagnosis of MDS\u002FMPN or CNL by WHO or ICC diagnostic criteria:\n\n  1. Chronic myelomonocytic leukemia\n  2. MDS\u002FMPN with neutrophilia, previously known as atypical chronic myeloid leukemia\n  3. Chronic neutrophilic leukemia\n  4. MDS\u002FMPN -not otherwise specified\n* Chronic phase disease with \\\u003C10% blasts in peripheral blood and marrow within 1 month from planned start of treatment\n* Eastern Cooperative Oncology Group (ECOG) Performance Score44 of 0-2\n* Patients can be treatment naïve or could have undergone prior treatments for MDS\u002FMPN as below:\n\n  1. Prior treatment with non-JAK inhibitors or hypomethylating agents are allowed (e.g., hydroxyurea, immunomodulatory agents, steroids). Hydroxyurea can be continued until or even beyond initiation of treatment for 2 months if needed for cytoreduction\n  2. If non-MMB JAK inhibitors were used for treatment and stopped due to side effects (e.g., anemia from ruxolitinib, gastrointestinal toxicity from fedratinib, etcetera), these patients will be allowed to enroll on this study as long as JAK inhibitor was stopped at least 2 weeks prior to anticipated start date of treatment\n  3. If prior hypomethylating agent was used and stopped longer than 3 months prior to anticipated start date of treatment due to side effects, these patients will be eligible. However, if hypomethylating agents were stopped due to lack of clinical benefit, these patients will not be deemed eligible\n  4. Prior treatment with erythropoietic stimulating agents is allowed if last treatment was more than 4 weeks prior to anticipated start date of treatment\n  5. Splenic radiation should have been performed more than 2 months before anticipated start date of treatment\n  6. Any prior or ongoing investigation therapy or agents should be stopped longer than 4 weeks of anticipated start date of treatment\n* Blood counts with platelets ≥25,000\u002FmicroL, ANC ≥0.75 x 10\\^9\u002FL (without transfusion or growth factor support)\n* Baseline splenomegaly with ≥5 cm below costal margin or ≥450 cm3 on imaging (ultrasound, CT or MRI)\n* Adequate organ function with creatinine clearance measured by Cockcroft-Gault calculation ≥30 mL\u002Fmin, total bilirubin ≤1.5×ULN (isolated bilirubin \\>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \\\u003C35%), INR ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within the therapeutic range of intended use of anticoagulants, albumin ≥2.5 g\u002FdL.\n* Willing and able to sign the informed consent form\n* Life expectancy \\> 24 weeks\n* Willing and able to complete patient-reported outcome assessments using an ePRO device according to protocol\n* Patients of child-bearing potential, or those with partners of child-bearing potential or pregnant or lactating partners, who are willing to follow highly effective contraceptive requirements. Females of reproductive potential should use effective contraception during study treatment and for 6 months following the last dose for HMA-MMB and 1 week following the last dose for MMB monotherapy. Males with female partners of reproductive potential should use effective contraception during study treatment and for 3 months following the last dose for HMA-MMB and 1 week following the last dose for MMB monotherapy. Patients should not breastfeed during treatment and for 1 week after the last dose.\n* Patients of child-bearing potential with a negative highly sensitive serum pregnancy test within 24 hours before the first dose of momelotinib.\n\nExclusion criteria\n\n* Diagnosis of MDS\u002FMPN with SF3B1 gene mutation and thrombocytosis (excluded due to unclear role of ACRV1 in the development of anemia)\n* Peripheral blood or marrow (by immunohistochemistry) blast percentage \\>10%\n* Prior lack of response to MMB or hypomethylating agents.\n* Known history of allergic reaction to momelotinib\n* AST or ALT above 2.5 x ULN (above 5 X ULN if liver is involved by extramedullary hematopoiesis as judged by the investigator or if related to iron chelator therapy that was started within the prior 60 days)\n* The following treatments within the time periods as specified:\n\n  1. Momelotinib at any time prior to screening\n  2. Erythropoietic stimulating agents within 4 weeks of treatment\n  3. Investigational agent within 4 weeks of the first dose of study treatment\n  4. Immunosuppressive agents within 28 days (low dose steroids ≤10 mg daily prednisone or equivalent is allowed)\n  5. Potent cytochrome P450 3A4 (CYP3A4) inducers, except for rifampin and rifampicin, within 14 days prior to the first dose of momelotinib. Strong CYP3A4 inducers can lead to decreased MMB exposure and risk a lack of efficacy. Therefore, alternative medicinal product to strong CYP3A4 inducer should be considered.\n* Unsuitable for spleen volume measurements due to prior splenectomy or unwilling or unable to undergo any imaging (ultrasound, CT without contrast or MRI without contrast) for spleen volume measurement per requirements\n* Patients with an active invasive concurrent malignancy, whose natural history or treatment has a significant potential to interfere with the safety or efficacy assessment of the investigational regimen.\n* Localized prostate cancer that has been treated surgically or by radiotherapy with curative intent and presumed cured is allowed.\n* History of non-melanoma skin cancers such as basal cell carcinoma or squamous cell carcinoma are also allowed.\n* Completely resected intraepithelial carcinoma of cervix or papillary thyroid or follicular thyroid cancers are also allowed at the investigator's discretion.\n* Untreated or active infections are excluded as below:\n\n  1. Chronic active or acute viral hepatitis A, B, or C infection. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative hepatitis C RNA test is obtained.\n  2. HIV with CD4+ cell count under 400 cells\u002F μL or on treatment with anti-retroviral therapy that is specifically excluded per the criteria above. HIV patients on established anti-retroviral therapy allowed per protocol for at least 4 weeks and CD4+ count above or equal to 400 cells\u002F μL\n  3. Infections requiring intravenous antibiotics\n* Nonhematologic toxicities from prior therapies that are unresolved and are of grade \\>1\n* Presence of peripheral neuropathy of grade ≥2\n* Pregnant women are excluded from this study because the effects of momelotinib on embryotoxicity, survival, and teratogenicity remain unclear.\n* Patients unable to swallow medications\n* Patient has any medical condition that puts the patient at an acceptable high risk with participation in the study per physician assessment or has any condition that confounds the ability to interpret data from the study.\n* Any major surgery or radiation or intervention that interferes with safety or feasibility of enrollment per investigator assessment","100 Years",{"count":495,"type":22},18,[183],"This research is being done to evaluate effectiveness, safety, and tolerability of a study drug called momelotinib in participants with myelodysplastic\u002Fmyeloproliferative neoplasms (MDS\u002FMPNs), MDS\u002FMPN-not otherwise specified (MDS\u002FMPN-NOS), MDS\u002FMPN with neutrophilia (MDS\u002FMPN-N), also called as atypical chronic myeloid leukemia, or chronic neutrophilic leukemia. Momelotinib will be added to standard treatment which usually includes a hypomethylating agent like azacitidine. Treatment options for this diagnosis remain limited and investigators need better treatments to help control the disease, improve symptoms, and potentially help more patients become eligible for transplant.\n\nParticipants for this study will be asked to take some screening tests which will include routine physical examination, blood tests, and imaging scans to determine eligibility for the study. Those who continue to qualify for this study will begin treatment and may be asked to remain on the study drug for up to 24 months, depending upon how they are responding to treatment. After the study drug is completed, patients will have one additional clinic visit to evaluate overall health and response to study drug. The study drug treatment on this study will include taking momelotinib by mouth in combination with azacitidine, which is given by injection for all patients for the first 5 days of each 28-day cycle.\n\nThe most common side effect that may be related to participation in this study can include (i) infections which can present as fever, chills, cough, breathing problems, diarrhea, vomiting, pain or burning with urination; or (ii) low blood platelet count which can result in bruising or bleeding for longer than usual if the participant hurts themself.",[30,87,499,500],"Myeloproliferative Overlap Neoplasms","Chronic Neutrophilic Leukemia",[502,503,504,505],"momelotinib","chronic neutrophilic leukemia","myelodysplastic","myeloproliferative","2026-03-25",{"date":508,"type":38},"2026-03-27",{"date":510,"type":38},"2026-03-19",{"date":512,"type":22},"2028-07-30",{"name":514,"class":45},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":516,"slug":517,"hasResults":12,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":23,"phases":525,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":539},"100488161","phase-1-combined-evaluation-of-epigenetic-and-sensitising-therapy-in-aml-and-mds-100488161","NCT05636514","Combined Evaluation of Epigenetic and Sensitising Therapy in AML and MDS","A Phase I Study of Oral Decitabine and Cedazuridine (ASTX727) In Combination With Defactinib (VS-6063) as Therapy of Myelodysplastic Syndromes and Low-blast Acute Myeloid Leukaemia","CELESTIAL-MDS","Inclusion Criteria:\n\nParticipants must meet all of the following criteria at the time of screening:\n\n1. Age ≥ 18 years\n2. Documented diagnosis of:\n\n   1. Myelodysplastic syndrome (MDS) classified as intermediate-2 or high risk according to the International Prognostic Scoring System (IPSS), or\n   2. Acute Myeloid Leukaemia (AML) with 20-30% marrow blasts and multilineage dysplasia, according to WHO classification, or\n   3. Chronic myelomonocytic leukemia (CMML) with 10-29% marrow blasts without myeloproliferative disorder according to World Health Organisation (WHO) classification. This confirmation will be from either the Bone marrow aspirate (BMA) performed at screening or a standard of care BMA if performed up to 6 weeks before cycle 1 day 1.\n3. Performance status by Eastern Cooperative Oncology Group (ECOG) Criteria of 0 or 1\n4. Unsuitable for allogeneic stem cell transplantation\n5. For participants who were born female who are of childbearing potential (FCBP) the following criteria apply:\n\n   1. Agreement to use at least two highly effective (per Clinical Trial Facilitation Group) contraceptive methods throughout the study, and for 6 months following the last dose of study drug:\n\n      * Oral\u002Fintravaginal\u002Ftransdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation\n      * Oral\u002Finjectable\u002Fimplantable progestogen-only hormonal contraception associated with inhibition of ovulation\n      * Intrauterine device (IUD)\n      * Intrauterine hormone-releasing system (IUS)\n      * Bilateral tubal occlusion\n      * Vasectomised partner\n      * Sexual abstinence and\n   2. Confirmation of a negative serum pregnancy test at screening.\n6. Male participants with a partner who was born female and is of childbearing potential must agree to use at least two highly effective (per Clinical Trial Facilitation Group) contraceptive methods throughout the course of the study and for 6 months following the last dose of study drug, and refrain from donating sperm during the same period\n7. Provision of signed written informed consent document prior to any study related assessments or procedures being carried out.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria at the time of screening\u002Fenrolment (up to 28 days prior to Cycle 1 Day 1) will be ineligible for entry into the study:\n\n1. Acute myeloid leukemia (AML) with ≥ 30% blasts in bone marrow according to WHO classification.\n2. Prior allogeneic or autologous stem cell transplant.\n3. Prior receipt of \\>1 cycle of a hypomethylating agent.\n4. Clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia.\n5. Use of any of the following within 28 days prior to cycle 1 day 1:\n\n   1. thrombopoiesis-stimulating agents (\\[TSAs\\]; eg, Romiplostim, Eltrombopag, Interleukin-11)\n   2. ESAs (Erythropoiesis stimulating agent) and other RBC (Red blood cell) hematopoietic growth factors (eg, interleukin-3)\n   3. Any other investigational medicinal product from another clinical trial.\n6. Exposure to any medication, supplement, traditional\u002Fherbal medicine, or food with potential for drug-drug interactions with defactinib during the course of the study. This includes:\n\n   1. strong CYP3A4 inhibitors or inducers\n   2. strong CYP2C9 inhibitors or inducers\n   3. P-glycoprotein (P-gp) inhibitors or inducers\n7. Treatment with warfarin. Patients on warfarin can be converted to low molecular-weight heparin or direct oral anticoagulants (DOACs). Participants unwilling or unable to convert to an alternative are not eligible.\n8. Use of hydrea for more than 7 days prior to cycle 1 day 1. Use within that time period is permissible.\n9. Concurrent use of corticosteroids unless the participant is on a dose of ≤10mg prednisolone or equivalent for medical conditions other than MDS.\n10. Active inflammatory bowel disease, or any other gastrointestinal disorder or defect that would interfere with the ingestion, absorption, distribution, metabolism or excretion of the investigational products and\u002For predispose the participant to an increased risk of gastrointestinal toxicity.\n11. Prior history of malignancies, other than MDS unless the participant has been free of the disease for ≥ 12 months. However, participants with the following history\u002Fconcurrent conditions are allowed:\n\n    1. Basal or squamous cell carcinoma of the skin\n    2. Carcinoma in situ of the cervix\n    3. Carcinoma in situ of the breast\n    4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, nodes, metastasis \\[TNM\\] clinical staging system)\n12. Significant active cardiac disease within the previous 6 months, including:\n\n    1. New York Heart Association (NYHA) class III or IV congestive heart failure;\n    2. Unstable angina or angina requiring surgical or medical intervention; and\u002For\n    3. Myocardial infarction\n13. Baseline Qt interval greater than 440 milliseconds (males) or 450 milliseconds (females)\n14. Active systemic infection:\n\n    1. Infection with ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate anti- infectives\n    2. Active Hepatitis B (HBV) infection (defined as HBsAg positive, or HBcAb positive and measurable HBV DNA; participants who are HBcAb positive must have HBV DNA assayed during screening)\n    3. Participants with Human Immunodeficiency Virus (HIV) or Hepatitis C (HCV) infection will be considered individually by the coordinating principal investigator:\n\n       * Those with HIV will generally be eligible if receiving antiretroviral therapy, HIV viral load (VL) is suppressed \\\u003C50 copies\u002FmL , and CD4≥350 cells\u002Fmm3.\n       * Those with HCV will generally be eligible if there is no evidence of clinical hepatic dysfunction or other systemic manifestations of HCV disease and the hepatic parameters below are met. Consideration should be given to curative HCV therapy prior to enrollment in consultation with HCV clinician, if possible.\n15. Any of the following laboratory abnormalities:\n\n    1. Serum AST\u002FSGOT (Aspartate transaminase \u002F Serum glutamic oxaloacetic transaminase) or ALT\u002FSGPT (Alanine aminotransaminase \u002F Serum glutamic pyruvate transaminase) \\> 2.5 x ULN (upper limit of normal)\n    2. Serum total bilirubin \\> 1.5 x ULN. Patients with Gilbert syndrome may enroll if total bilirubin \\\u003C 51 umol\u002FL upon discussion with the coordinating investigator\n    3. Evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of \\> 2% with either a positive direct anti-globulin test (DAT) or over 50% of indirect bilirubin\n    4. Creatinine clearance \\\u003C50 ml\u002Fminute as calculated by the CockcroftGault formula or serum creatinine of ≥ 1.5 x ULN.\n    5. Absolute WBC (white blood cell count) ≥ 20 x 109\u002FL f ) Participants with isolated individual lab abnormalities considered to be disease related will be considered individually in consultation with the Coordinating Principal Investigator.\n16. Known or suspected hypersensitivity to study drugs or their constituents.\n17. Pregnant or breast-feeding.\n18. Any condition not already outlined above which, in the opinion of the clinical investigator, would place the participant at risk if they participated or would jeopardise adherence or follow up or confound the ability to interpret study data.",{"count":524,"type":22},12,[57],"The goal of this project is to see if two new potential treatments (defactinib and the combination tablet of decitabine\u002Fcedazuridine) can safely be combined to improve outcomes in people with high-risk myelodysplastic syndrome (MDS), certain forms of Acute Myeloid Leukaemia (AML), and Chronic Myelomonocytic Leukaemia (CMML). Decitabine\u002Fcedazuridine is approved for use by the Australian Therapeutics Goods Administration (TGA) as treatment for MDS. Defactinib is an experimental treatment. This means it is not an approved treatment for MDS in Australia. So far it has been given to over 625 patients in studies across the world.\n\nAll study participants will receive active treatment, there is no placebo. Participants will take the decitabine\u002Fcedazuridine treatment once a day for 5 days in a row (day 1 to day 5) on its own for the first month (cycle). From month 2 participants will take the decitabine\u002Fcedazuridine treatment and will also take the defactinib treatment, both for 5 days in a row on days 1 to day 5 each month (cycle). Defactinib is taken twice a day.",[87,30,29],[87,30,29,380,379,382],"2026-03-16",{"date":531,"type":38},"2026-03-18",{"date":533,"type":38},"2022-12-14",{"date":535,"type":22},"2027-12-30",{"name":537,"class":538},"Clinical Hub for Interventional Research (CHOIR)","OTHER_GOV",5,{"id":541,"slug":542,"hasResults":12,"nctId":543,"briefTitle":544,"officialTitle":545,"acronym":4,"eligibilityCriteria":546,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":23,"phases":549,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":46},"100556319","phase-1-axatilimab-with-or-without-azacitidine-for-the-treatment-of-patients-with-advanced-phase-myeloproliferative-neoplasms-myeloproliferative-neoplasmmyelodysplastic-syndrome-overlap-or-high-risk-chronic-myelomonocytic-leukemia-100556319","NCT06523556","Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm\u002FMyelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia","Phase 1b\u002F2 Study of Axatilimab (SNDX-6352) + Azacitidine (AZA) in Advanced Phase MPN, MPN\u002FMDS Overlap or High-Risk CMML","Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Age ≥ 18 years at the date of signing the informed consent form (ICF)\n* Morphologically confirmed diagnosis of the following based on 2016 World Health Organization (WHO) classification (Arber et al 2016): Phase 1b, patients with relapsed or refractory of any of the following; phase 2, patients with newly diagnosed of any of the following:\n\n  * Chronic myelomonocytic leukemia (CMML), classified as intermediate-2, OR high-risk per the CMML Specific Prognostic Scoring System (CPSS) Molecular Model\n  * Atypical chronic myelocytic leukemia (aCML)\n  * MDS\u002FMPN unclassified (MDS\u002FMPN-U)\n  * Myeloproliferative neoplasm accelerated phase (MPN-AP)\n  * MPN-AP requires a previous diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or primary myelofibrosis (PMF) with intermediate-2 or high risk disease according to International Prostate Symptom Score (IPSS) as well as progression on or failure to respond to at least one line of therapy.\n  * Myelodysplastic syndrome\u002Fmyeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS\u002FMPN-RS-T) or MDS\u002FMPN with SF3B1 mutation and thrombocytosis (MDS\u002FMPN-SF3B1-T).\n  * Not suitable for immediate myeloablative\u002Fintensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m\\^2 (estimation based on Modification of Diet in Renal Disease \\[MDRD\\] formula, by local laboratory)\n* Patient is able to communicate with the investigator and has the ability to comply with the requirements of the study procedures\n* Women of childbearing potential and men, if not surgically sterilized, should use adequate contraception from 14 days prior to study entry and until 90 days after the last follow-up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom\n\nExclusion Criteria:\n\n* Previous treatment for MPN or MDS\u002FMPN overlap with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine or INQOVI (oral decitabine) (patients who had up to 2 cycles of hypomethylating agents \\[HMAs\\] can be included). However, previous treatment with hydroxyurea and\u002For ruxolitinib is permitted\n* Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary AML based on WHO 2016 classification (Arber et al 2016)\n* Patients who are candidates for myeloablative or intensive chemotherapy treatment or who do not provide consent for this treatment\n* History of organ transplant or allogenic hematopoietic stem cell transplant\n* Participants with prior malignancy, except:\n\n  * Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study.\n  * Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible\n* Previous known allergy\u002Fsensitivity to components of axatilimab\n* History of acute or chronic pancreatitis\n* History of myositis",{"count":548,"type":22},52,[57,25],"This phase Ib\u002FII trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative neoplasm\u002Fmyelodysplastic syndrome (MPN\u002FMDS) overlap or high risk chronic myelomonocytic leukemia (CMML). Axatilimab is an antibody that is cloned from a single white blood cell that is known to be able to recognize cancer cells and block a protein on the surface of the white blood cells that may be involved in cancer cell growth. By blocking the proteins, this may slow or halt the growth of the cancer. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving axatilimab with or without azacitidine may be safe and effective in treating patients with advanced phase MPN, MPN\u002FMDS overlap or high risk CMML.",[186,30,189,552,553,290,554,555],"Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Recurrent Myeloproliferative Neoplasm","Refractory Myelodysplastic\u002FMyeloproliferative Neoplasm","Refractory Myeloproliferative Neoplasm","2026-03-11",{"date":558,"type":38},"2026-03-13",{"date":560,"type":38},"2024-08-02",{"date":562,"type":22},"2028-10-31",{"name":564,"class":45},"Uma Borate",{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":23,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":582,"leadSponsor":584,"locationsCount":585},"100557843","phase-1-olutasidenib-for-the-treatment-of-patients-with-idh1-mutated-aml-mds-or-cmml-after-donor-hematopoietic-cell-transplant-100557843","NCT06543381","Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML After Donor Hematopoietic Cell Transplant","Pilot Trial of Olutasidenib Maintenance Post Allogeneic Hematopoietic Cell Transplantation in Patients Carrying IDH1 Mutation With AML, MDS, or CMML Disease","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2 or Karnofsky performance status (KPS) ≥ 70\n* Patients who are scheduled to receive or have already undergone allogeneic hematopoietic cell transplantation (alloHCT) from any donor type, any conditioning regimen, and regardless of GVHD prophylaxis will be include\n* Patients must have AML, MDS, or CMML with mIDH1 diagnosis at diagnosis (regardless of time from HCT). Note: Patient with pre-HCT disease relapse will no be included if mIDH1 is not detected after relapse\n* Day 30 marrow post alloHCT should show evidence of morphologic remission with \\\u003C 5% bone marrow (BM) blasts. Patients with MRD-positive status either by flow cytometry or IDH1 mutation testing will be eligible\n* Patients with previous therapy with IDH1 inhibitors will be included\n* Absolute neutrophil count (ANC) \\> 1000\u002Fmm\\^3 (within 28 days prior to day 1 of protocol)\n* Hemoglobin ≥ 8.0 gm\u002FdL (within 28 days prior to day 1 of protocol)\n* Platelets ≥ 50,000\u002Fmm\\^3 (within 28 days prior to day 1 of protocol) Note: Patients with lower counts can enroll if infection cytomegalovirus (CMV)\u002Fhuman herpes virus 6 (HHV6), etc. is being treated actively\n* Bilirubin ≤ 2 x upper limit of normal (ULN) (within 28 days prior to day 1 of protocol) (unless has Gilbert's disease). Patients with abnormal liver function tests (LFTs) due to active GVHD will not be eligible\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 2 x ULN (within 28 days prior to day 1 of protocol). Patients with abnormal LFTs due to active GVHD will not be eligible\n* Creatinine clearance of ≥ 30\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal per 24 hour urine test or the Cockcroft-Gault formula (within 28 days prior to day 1 of protocol)\n* Corrected QT interval (QTc) ≤ 480 ms (Note: To be performed within 28 days prior to day 1 of protocol therapy)\n* Seronegative for HIV antigen\u002Fantibody (Ag\u002FAb) combo, hepatitis C virus (HCV) (if positive, hepatitis C ribonucleic acid \\[RNA\\] quantitation must be performed), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \\[RPR\\]) (within 28 days prior to day 1 of protocol)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 28 days prior to day 1 of protocol). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential, defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only), to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\nExclusion Criteria:\n\n* Patients with more than one allogeneic HCT\n* History of allergic reactions attributed to compounds of similar chemical or biological composition to study agent\n* Active diarrhea considered clinically significant and may impair oral drug administration\n* Clinically significant uncontrolled illness\n* Uncontrolled infection requiring systemic antimicrobials\n\n  * Active infection: Patients with treated viral, bacterial or fungal infections that are controlled on therapy will be allowed to participate\n* Participant has detectable human immunodeficiency virus (HIV) viral load within the previous 6 months (must have viral load testing prior to study enrollment if participant has a known history of HIV 1\u002F2 antibodies)\n* Active hepatitis B or C, or HIV\n* Other active malignancy. Participants with history of prior malignancy treated with curative intent who achieved CR more than 2 years before study entry are eligible. This exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer\n* Females only: Pregnant or breastfeeding\n* Active grade II-IV acute GVHD per Mount Sinai Acute Graft Versus Host Disease International Consortium (MAGIC) criteria and\u002For requiring systemic steroids with prednisone dose equivalent of ≥ 0.25 mg\u002Fkg at end of 4 weeks. Patients with a mild form of acute GVHD involving skin, gut or liver requiring topical steroid creams or oral beclomethasone (8 mg\u002Fday), entocort, (9 mg\u002Fday) and\u002For solumedrol (and equivalent prednisone) will be allowed\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":573,"type":22},15,[57],"This phase I trial tests the safety, side effects, and effectiveness of olutasidenib in preventing the return of disease (relapse) in patients who have undergone donor (allogeneic) hematopoietic cell transplant for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML) carrying an IDH1 mutation. Olutasidenib is in a class of medications called IDH1 inhibitors. It works by slowing or stopping the growth of cancer cells. Giving olutasidenib may be safe, tolerable and\u002For effective in preventing relapse in patients with IDH1 mutated AML, MDS or CMML after an allogeneic hematopoietic cell transplant.",[29,30,32],"2026-03-03",{"date":579,"type":38},"2026-03-05",{"date":581,"type":38},"2025-01-17",{"date":583,"type":22},"2027-02-05",{"name":44,"class":45},2,{"id":587,"slug":588,"hasResults":12,"nctId":589,"briefTitle":590,"officialTitle":591,"acronym":4,"eligibilityCriteria":592,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":593,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":46},"100338206","phase-2-enasidenib-and-azacitidine-in-treating-patients-with-recurrent-or-refractory-acute-myeloid-leukemia-and-idh2-gene-mutation-100338206","NCT03683433","Enasidenib and Azacitidine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia and IDH2 Gene Mutation","Phase II Study of the Targeted Mutant IDH2 Inhibitor Enasidenib in Combination With Azacitidine for Relapsed\u002FRefractory AML","Inclusion Criteria:\n\n* Patients with AML or biphenotypic or bilineage leukemia (including a myeloid component) who have failed prior therapy. Patients with isolated extramedullary AML are eligible. The World Health Organization (WHO) classification will be used for AML\n* Elderly (\\> 60 years old) patients with newly diagnosed AML not eligible for intensive chemotherapy are also eligible\n* AML patients with prior history of myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) regardless of prior therapy received, are eligible at the time of diagnosis of AML\n* Subjects must have documented IDH2 gene mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3\n* Adequate renal function including creatinine \\\u003C 2 unless related to the disease\n* Total bilirubin \\\u003C 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\\u003C 3 x ULN unless considered due to leukemic involvement\n* Provision of written informed consent\n* Oral hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the principal investigator (PI). Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted\n* Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment\n* Women of childbearing potential must agree to use an adequate method of contraception during the study and until 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment\n\nExclusion Criteria:\n\n* Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \\[FAB\\] class M3-AML)\n* Active and uncontrolled comorbidities including active uncontrolled infection, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure New York Heart Association (NYHA) class III\u002FIV, clinically significant and uncontrolled arrhythmia as judged by the treating physician\n* Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator\n* Pregnant or breastfeeding",{"count":159,"type":22},[25],"This phase II trial studies how well enasidenib and azacitidine work in treating patients with IDH2 gene mutation and acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). Enasidenib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.",[597,251,30,598,32,113,117],"Acute Bilineal Leukemia","IDH2 Gene Mutation",{"date":579,"type":38},{"date":601,"type":38},"2018-09-18",{"date":603,"type":22},"2027-09-20",{"name":276,"class":45},{"id":606,"slug":607,"hasResults":12,"nctId":608,"briefTitle":609,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":209,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":23,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":46},"100559639","phase-2-a-phase-2-study-evaluating-olutasidenib-in-patients-with-idh1-mutated-clonal-cytopenia-of-undetermined-significance-and-lower-risk-myelodysplasticsyndromeschronic-myelomonocytic-leukemia-100559639","NCT06566742","A Phase 2 Study Evaluating Olutasidenib in Patients With IDH1-mutated Clonal Cytopenia of Undetermined Significance and Lower-risk Myelodysplastic\u002FSyndromes\u002FChronic Myelomonocytic Leukemia.","Inclusion Criteria:\n\n1. Pathologically proven CCUS or lower-risk MDS\u002FCMML.\n\n   1. CCUS is defined as the presence of cytopenia (absolute neutrophil count \\\u003C 1.8 x 10\\^9\u002FL, hemoglobin \\\u003C 13 g\u002FdL in males or \\\u003C 12 g\u002FdL in females, and\u002For platelets \\\u003C 150 x 10\\^9\u002FL) for at least 30 days that are otherwise unexplained and with no diagnostic hematopathologic features of myeloid neoplasms. Patients with known Duffy-null phenotype must have absolute neutrophil counts less than their lower limit of normal.\n   2. Lower-risk MDS\u002FCMML includes patients with International Prognostic Scoring System (IPSS) low- or intermediate-1-risk disease and Revised IPSS (IPSS-R) score ≤ 3.5 and Molecular IPSS (IPSS-M) very low-, low-, or moderate low-risk categories.\n2. Patients must have a documented IDH1 mutation with variant allele frequency (VAF) ≥ 0.02.\n3. Patients ≥ 18 years old.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n5. Bilirubin ≤ 2 times upper limit of normal (ULN) or ≤ 3 times ULN in patients with Gilbert Syndrome.\n6. Aspartate transaminase (AST), alanine transaminase (ALT), and alkaline phosphatase ≤ 3 times ULN.\n7. Acceptable renal function with serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 50 mL\u002Fmin (as assessed by Cockcroft-Gault, Modification of Diet in Renal Disease Formula \\[MDRD\\], or Chronic Kidney Disease Epidemiology \\[CKD-Epi\\] validated measures).\n8. Negative serum or urine pregnancy test if female of childbearing potential.\n9. For fertile men and women, agreement to use highly effective contraceptive methods for the duration of study participation and 90 days after the last dose of study medication. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide).\n10. Agreement for male patients not to donate sperm and for female patients of childbearing potential not to donate ova during the study and for 90 days after the final dose of study drug.\n11. Ability and willingness to signed informed consent prior to beginning study and undergoing procedures.\n\nExclusion Criteria:\n\n1. Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g., malabsorption, resection, etc.) deemed by the Investigator to jeopardize intestinal absorption.\n2. Patients with any concurrent uncontrolled clinically significant medical condition, including life-threatening severe infection or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n3. Known active hepatitis B (hepatitis B virus \\[HBV\\]) or hepatitis C (hepatitis C virus \\[HCV\\]) or HIV infection.\n4. Pregnant or nursing women or women of childbearing potential not using highly effective contraception; male patients not using highly effective contraception as defined in the inclusion criteria.\n5. Subject with white blood cell count \\> 25 x10\\^9\u002FL.\n\n   * Note: hydroxyurea use is permitted to meet this criterion with no washout required.\n6. Unwillingness or inability to comply with procedures either required in this protocol or considered standard of care.",{"count":573,"type":22},[25],"To learn if olutasidenib can help to control CCUS, MDS, and\u002For CMML. The safety of the drug will also be studied.",[87,30,473],"2026-03-02",{"date":617,"type":38},"2026-03-04",{"date":619,"type":38},"2024-12-10",{"date":621,"type":22},"2029-08-31",{"name":276,"class":45},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":209,"sex":17,"minAge":18,"maxAge":367,"enrollmentInfo":629,"targetDuration":4,"studyType":23,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":46},"100416851","phase-2-venetoclax-to-improve-outcomes-of-fractionated-busulfan-regimen-in-patients-with-high-risk-aml-and-mds-100416851","NCT04708054","Venetoclax to Improve Outcomes of Fractionated Busulfan Regimen in Patients With High-Risk AML and MDS","Inclusion Criteria:\n\nPhase II\n\n1. Age ≥ 18 and ≤ 70 years. English and non-English speaking patients are eligible.\n2. Patients with acute myeloid leukemia who have previously received induction therapy and one of the following high-risk features:\n\n   1. ELN17 adverse risk prognostic group irrespective of remission status (see Appendix 2)\n   2. Measurable residual disease positive (MRD +)\n   3. Not in complete remission including complete remission without count recovery (Cri) and\u002For morphologic leukemia free state (MLFS), primary refractory, or relapsed disease. See Appendix 3 for details.\n   4. AML secondary to MDS or MPD\n   5. Therapy-related AML.\n   6. Not in complete remission after one course of induction therapy\n\n   Or\n\n   Patients with myelodysplastic syndrome or CMML and one of the following high-risk features:\n   1. Poor or Very poor cytogenetic risk group as per IPSS-R\n   2. Mutated P53 or Ras pathway genes (CBL, NRAS, KRAS, NF1, PTPN1) or DNMT 3a or ASXL1 or RUNX1\n   3. Maximum IPSS-R \\>3.5 between diagnosis and the start of the preparative regimen.\n   4. ≥ 5% BM blasts at transplant\n   5. Therapy-related MDS\n3. HLA-identical sibling or a minimum of 7\u002F8 matched unrelated donor, or a haploidentical related donor available\n4. Subject must voluntarily sign an informed consent\n5. Female subjects of childbearing potential must have negative results for pregnancy test\n6. Adequate hepatic and renal function per local laboratory reference range as follows:\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C 3.0X ULN\n   * Bilirubin \\\u003C1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n   * Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 50 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.\n\nPhase III\n\n1. Age ≥ 18 and ≤ 65 years. English and non-English speaking patients are eligible.\n2. Patients with acute myeloid leukemia who have previously received induction therapy and one of the following high-risk features:\n\n   1. ELN22 adverse risk prognostic group irrespective of remission status (see Appendix\n   2. Measurable residual disease positive (MRD +) including MRD + any time after induction therapy.\n   3. Not in complete remission including complete remission without count recovery (Cri) and\u002For morphologic leukemia free state (MLFS), primary refractory, or relapsed disease. See Appendix 4 for details.\n   4. AML secondary to MDS or MPD\n   5. Therapy-related AML.\n   6. Not in complete remission after one course of induction therapy\n   7. Second or higher complete remission\n\n   Or\n\n   Patients with myelodysplastic syndrome and one of the following high-risk features:\n   1. Poor or Very poor cytogenetic risk group as per IPSS-R\n   2. Mutated P53 or Ras pathway genes (CBL, NRAS, KRAS, NF1, PTPN11) or ASXL1 or RUNX1 or moderate high, or high, or very high-risk group as per IPSS-M\n   3. Maximum IPSS-R \\>3.5 between diagnosis and the start of the preparative regimen.\n   4. ≥ 5% BM blasts at transplant\n   5. Therapy-related MDS\n\n   Or\n\n   Patients with CMML\n3. HLA-identical sibling or a minimum of 7\u002F8 matched unrelated donor\n4. Subject must voluntarily sign an informed consent\n5. Female subjects of childbearing potential must have negative results for pregnancy test\n6. Adequate hepatic and renal function per local laboratory reference range as follows:\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C 3.0X ULN\n   * Bilirubin \\\u003C1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n   * Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 50 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.\n\nExclusion criteria:\n\n1. Subject is known to be positive for HIV.\n2. Subject has cognitive impairments and\u002For is a prisoner.\n3. Subject has acute promyelocytic leukemia\n4. Subject has known active CNS involvement with AML.\n5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n   2. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate.\n6. Cardiac history of CHF requiring treatment or Ejection Fraction \\\u003C 50% or unstable angina;\n7. Corrected DLCO \\\u003C 50% or FEV1 \\\u003C65%.\n8. Administration or consumption of any of the following within 3 days prior to the first dose of study drug:\n\n   * grapefruit or grapefruit products\n   * Seville oranges (including marmalade containing Seville oranges)\n   * star fruit\n9. Patients with cognitive impairments and\u002For any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with obtaining informed consent or compliance with study procedures.\n10. Prior allogeneic stem cell transplantation.",{"count":630,"type":22},324,[25,409],"This phase II trial studies the effect of venetoclax together with busulfan, cladribine, and fludarabine in treating patients with high-risk acute myeloid leukemia or myelodysplastic syndrome who are undergoing stem cell transplant. Chemotherapy drugs, such as venetoclax, busulfan, cladribine, and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax to the current standard of care stem cell transplant regimen of busulfan, fludarabine, and cladribine may help to control high-risk acute myeloid leukemia or myelodysplastic syndrome.",[29,30,32],"2026-02-17",{"date":636,"type":38},"2026-02-19",{"date":638,"type":38},"2021-10-21",{"date":640,"type":22},"2027-12-31",{"name":276,"class":45},{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":649,"maxAge":4,"enrollmentInfo":650,"targetDuration":4,"studyType":23,"phases":652,"briefSummary":653,"conditions":654,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":658,"lastUpdatePostDateStruct":659,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":665},"100315211","phase-2-azacitidine-and-enasidenib-in-treating-patients-with-idh2-mutant-myelodysplastic-syndrome-100315211","NCT03383575","Azacitidine and Enasidenib in Treating Patients With IDH2-Mutant Myelodysplastic Syndrome","Targeted Therapy With the IDH2-Inhibitor Enasidenib (AG221) for High-Risk IDH2-Mutant Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Signed, informed consent must be obtained prior to any study specific procedures\n* Subjects with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts in transformation (RAEB-T) (acute myeloid leukemia \\[AML\\] with 20-30% blasts and multilineage dysplasia by French-American-British \\[FAB\\] criteria) by World Health Organization (WHO), and chronic myelomonocytic leukemia (CMML) are eligible\n* Subjects must have an IDH2 gene mutation (IDH2-R140 or R172) as determined by local laboratory result\n* (Arm A only): Subject must be hypomethylating agent naive (i.e. prior azacitidine, decitabine, SGI-110 is exclusionary). Receipt of other MDS-directed therapy such as lenalidomide is allowed\n* (Arm A only): Subjects with high-risk MDS (i.e. International Prostate Symptom Score \\[IPSS\\] intermediate-2 or high-risk; or revised \\[R\\]-IPSS high or very-high risk). Patients with intermediate-1 risk by IPSS or intermediate risk by R-IPSS with high-risk molecular features including TP53, ASXL1, EZH2, and\u002For RUNX1 mutations are also eligible\n* (Arm B only): Subject must be relapsed or refractory to prior hypomethylating agent therapy, defined as prior receipt of 6 cycles of HMA therapy with failure to attain a response, or relapse after prior response to HMA therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Serum bilirubin =\\\u003C 2 x the upper limit of normal (ULN) (except for patients with Gilbert's disease)\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) =\\\u003C 3 x the laboratory ULN\n* Serum creatinine =\\\u003C 2 x the ULN\n* Able to understand and voluntarily sign a written informed consent, and willing and able to comply with protocol requirements\n* Resolution of all clinically significant treatment-related, non-hematological toxicities, except alopecia, from any previous cancer therapy to =\\\u003C grade 1 prior to the first dose of study treatment\n* Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days of the first dose of study drug and agree to use dual methods of contraception during the study and for a minimum of 3 months following the last dose of study drug. Post-menopausal females (\\> 45 years old and without menses for \\> 1 year) and surgically sterilized females are exempt from these requirements. Male patients must use an effective barrier method of contraception during the study and for a minimum of 3 months following the last dose of study drug if sexually active with a female of childbearing potential\n\nExclusion Criteria:\n\n* Any prior or coexisting medical condition that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study\n* Subject has received a prior targeted IDH2 inhibitor\n* Psychiatric disorders or altered mental status precluding understanding of the informed consent process and\u002For completion of the necessary study procedures\n* Active uncontrolled infection at study enrollment including known diagnosis of human immunodeficiency virus or chronic active hepatitis B or C infection\n* Clinically significant gastrointestinal conditions or disorders that may interfere with study drug absorption, including prior gastrectomy\n* Patients with known active central nervous system (CNS) disease, including leptomeningeal involvement\n* Impaired cardiac function, uncontrolled cardiac arrhythmia, or clinically significant cardiac disease including the following: a) New York Heart Association grade III or IV congestive heart failure, b) myocardial infarction within the last 6 months\n* Subjects with a corrected QT (QTc) \\> 480 ms (QTc \\> 510 msec for subjects with a bundle branch block at baseline\n* Nursing or pregnant women\n* Subjects with known hypersensitivity to study drugs or their excipients","12 Years",{"count":651,"type":22},63,[25],"This phase II trial studies the side effects and how well azacitidine and enasidenib work in treating patients with IDH2-mutant myelodysplastic syndrome. Azacitidine and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.",[29,655,30,598,112,656,657],"Blasts 20-30 Percent of Bone Marrow Nucleated Cells","Recurrent High Risk Myelodysplastic Syndrome","Refractory High Risk Myelodysplastic Syndrome","2026-02-13",{"date":634,"type":38},{"date":661,"type":38},"2018-01-17",{"date":663,"type":22},"2027-02-28",{"name":276,"class":45},3,{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":4,"eligibilityCriteria":672,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":673,"targetDuration":4,"studyType":23,"phases":675,"briefSummary":676,"conditions":677,"keywords":684,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":689,"lastUpdatePostDateStruct":690,"startDateStruct":692,"completionDateStruct":694,"leadSponsor":696,"locationsCount":698},"100589101","phase-1-a-phase-1-study-of-stx-0712-in-patients-with-advanced-hematological-malignancies-cmml-and-aml-100589101","NCT06950034","A Phase 1 Study of STX-0712 in Patients With Advanced Hematological Malignancies (CMML and AML)","A Phase 1, Open-Label, Dose Escalation and Expansion Study of STX-0712 in Patients With Advanced Hematologic Malignancies","Inclusion Criteria:\n\n* Refractory\u002Fresistant CMML, defined as: Diagnosis of CMML 1 or 2; and has not responded to at least 4 cycles of hypomethylating agents (HMAs)(for myeloproliferative CMML - HMAs or hydroxyurea) or discontinued prior to 4 cycles due to toxicity or has progressive disease OR\n* Relapsed\u002Frefractory monocytic or monocytic predominant AML. Monocytic predominant AML is defined as ≥50% monocytes and\u002For monocytic precursors (promonocytes\u002Fmonoblasts) and expressing at least two monocytic markers including CD4, CD11c, CD14, CD36, or CD64; and peripheral blood white blood cell (WBC) \\\u003C30,000\u002FµL (microliters) and \\\u003C20% circulating blasts.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2.\n* Life expectancy of \\>2 months and stable enough to complete two cycles of STX-0712, in the opinion of the Investigator.\n* Adequate organ function.\n* Both females of child-bearing potential and males must agree to use acceptable contraceptive methods for the duration of time in the study and to continue to use acceptable contraceptive methods for 90 days after last STX-0712 infusion.\n* Able to understand and willing to sign a written informed consent form.\n* Willing and able to comply with study procedures and follow-up examinations.\n\nExclusion Criteria:\n\n* Has any of the following disease-specific conditions: For CMML: Myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) overlap syndromes other than CMML. For AML: Acute Promyelocytic Leukemia (APL) or Isolated extramedullary disease.\n* Eligible for an immediate allogenic stem cell transplant (alloSCT).\n* Current active use of nicotine products including tobacco, nicotine patches or vaping products.\n* Prior bone marrow transplant (BMT) within 6 months of date of consent; or transplanted patients who received the last dose of immunosuppressive therapies within 3 months of date of consent.\n* Has active autoimmune condition requiring immunosuppressive treatment or is receiving immunosuppressive therapy for the treatment of autoimmune disorders, allergies, or other clinical symptoms. Systemic steroids \\\u003C10 mg (milligrams) daily of prednisone equivalent are allowed; and intermittent use of bronchodilators or inhaled steroids, local steroid injections, topical steroids are allowed.\n* Received treatment with chemotherapy, biologic therapy, or wide-field radiation within 14 days of consent. Exceptions for hydroxyurea: For CMML and AML participants, hydroxyurea may be continued up to 72 hours prior to first dose of STX-0712. Hydroxyurea will also be permitted for first cycle of STX-0712 treatment for participants with proliferative CMML or AML with high white blood count (WBC ≥25,000\u002FµL).\n* Received an investigational treatment within 30 days prior to dosing with STX-0712.\n* Received Granulocyte Colony Stimulating Factor \\[G-CSF\\], Granulocyte Macrophage Colony Stimulating Factor \\[GM-CSF\\], erythropoietin, romiplostim, or other growth factors within 2 weeks prior to first dose of STX- 0712.\n* Received a live or live attenuated vaccine within 30 days before the first dose of STX-0712.\n* Clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association class 3 or 4 congestive heart failure, uncontrolled or unstable chest pain, history of heart attack(s), or stroke within 6 months prior to consent, uncontrolled high blood pressure, or clinically significant arrhythmias not controlled by medication).\n* QT interval corrected by Fridericia's formula (QTcF) \\>470 msec for both men and women on Screening electrocardiogram(s) (ECG). Patients with a bundle branch block must have QT interval corrected for bundle branch block.\n* Other than AML or CMML, active malignancy and\u002For cancer history that requires active therapy. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.\n* Active, uncontrolled bacterial, fungal, or viral infection.\n* Known human immunodeficiency virus (HIV).\n* Active or chronic hepatitis B or hepatitis C infection.\n* Evidence of any other severe or uncontrolled systemic diseases, any other serious and\u002For unstable pre-existing medical conditions, psychiatric disorder, or other conditions that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator.",{"count":674,"type":22},105,[57],"This is a first-in-human, multicenter, open-label, phase 1 study to evaluate the safety, PK, PD and preliminary efficacy of STX-0712 in patients with advanced CMML and AML for whom there are no further treatment options known to confer clinical benefit.",[30,419,678,679,290,382,29,417,680,681,682,683],"Chronic Myelomonocytic Leukemia-1","Chronic Myelomonocytic Leukemia-2","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemias","Refractory Acute Myeloid Leukemia (AML)","Acute Monocytic Leukemia",[685,382,379,686,687,688,30,29,290,117],"refractory\u002Fresistant CMML","monocytic AML","Relapsed\u002Frefractory AML","monocytic-predominant AML","2026-02-05",{"date":691,"type":38},"2026-02-09",{"date":693,"type":38},"2025-03-13",{"date":695,"type":22},"2027-06-30",{"name":697,"class":96},"Solu Therapeutics, Inc",7]