[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-chronic-myelomonocytic-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-chronic-myelomonocytic-leukemia":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,70,93,142,166,186,207],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100481488","phase-1-onvansertib-for-the-treatment-of-recurrent-or-refractory-chronic-myelomonocytic-leukemia-and-myelodysplastic-syndromempn-overlap-neoplasms-100481488",false,"NCT05549661","Onvansertib for the Treatment of Recurrent or Refractory Chronic Myelomonocytic Leukemia and Myelodysplastic Syndrome\u002FMPN Overlap Neoplasms","Phase 1 Study to Determine the Safety and Efficacy of Onvansertib, A Novel, Oral, PLK1 Inhibitor in Patients With Proliferative Chronic Myelomonocytic Leukemia (CMML) and Myelodysplastic Syndrome\u002FMPN Overlap Neoplasms Relapsed\u002FRefractory or Intolerant to Available Therapies","Inclusion Criteria:\n\nPRE-REGISTRATION - INCLUSION CRITERIA:\n\n* Age \\>= 18 years\n* History of World Health Organization (WHO)-defined diagnosis of proliferative CMML (WBC count \\>= 13,000\u002Fmm\\^3 at time of diagnosis), or MDS\u002FMPN overlap neoplasm with WBC count \\>= 13,000\u002Fmm3 at time of diagnosis (atypical CML and MDS\u002FMPN-NOS).\n\n  * NOTE: Hydroxyurea or hypomethylating induced leukopenia does not preclude inclusion. Discussion of WBC \\\u003C 13,000\u002Fmm\\^3 due to treatment at the time of preregistration must be discussed with the Sponsor\u002FPrincipal Investigator\n* Relapsed\u002Frefractory following treatment with hydroxyurea; or at least 4 cycles of treatment with hypomethylating agents; or who are intolerant of treatment with either therapy. Note: Prior exposure to erythropoiesis stimulating agents is allowed. Hydroxyurea may continue for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the Sponsor\u002FPrincipal Investigator\n* Willing and able to review, understand, and provide written consent before starting any study-specific procedures or therapy\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willingness to provide mandatory bone marrow specimens for correlative research\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Recovered to grade 1 or baseline or established as sequelae from all toxic effects of previous therapy except alopecia\n* Platelet count \\>= 20,000\u002Fmm\\^3 (obtained =\\\u003C 14 days prior to pre-registration)\n\n  * NOTE: For platelet count \\\u003C 20,000\u002Fmm3 and in situations where the primary investigator deems the thrombocytopenia to be attributable to the underlying CMML, patients can be enrolled as long as they are able to achieve a platelet count of 20,000\u002Fmm3 with transfusional support\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN) (=\\\u003C 3 x ULN for patients with Gilbert's syndrome) (obtained =\\\u003C 14 days prior to pre-registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\\u003C 3 x ULN (obtained =\\\u003C 14 days prior to pre-registration)\n* Estimated glomerular filtration rate (eGFR) \\>= 50 mL\u002Fmin\u002Fm\\^2 using one of the following methods (obtained =\\\u003C 14 days prior to pre-registration):\n\n  * Chronic Kidney Disease-Epidemiology Collaboration (CKDEPI) 2021 formula\n  * Corrected creatinine clearance via serum and 24-hour urine creatinine assessment\n  * Iothalamate\u002FIohexol glomerular filtrate rate via plasma\u002Furine assessment\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to provide mandatory blood specimens for correlative research\n\nREGISTRATION - INCLUSION CRITERIA:\n\n* Histological confirmation of WHO-defined diagnosis of a myelodysplastic\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) including one of the following (NOTE: to confirm patient is still eligible and has not progressed to\n\nAML):\n\n* Proliferative CMML\n* Atypical chronic myeoloid leukemia (aCML)\n* MDS\u002FMPN not otherwise specified (MDS\u002FMPN, NOS)\n* NOTE: Hydroxyurea or hypomethylating agent induced leukopenia does not preclude inclusion. Discussion of WBC \\\u003C 13,000\u002Fmm\\^3 due to treatment at the time of registration must be discussed with the Sponsor\u002FPrincipal Investigator.\n\n  * For a man or a woman of child-bearing potential (WOCBP): Must agree to use contraception or take measures to avoid pregnancy during the study and for 180 days after the final dose of any study drug. Adequate contraception is defined as follows:\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\n    * WOCBP must have a negative serum or urine pregnancy test =\\\u003C 7 days prior to registration\n* NOTE: WOCBP include any female 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 (eg, vasectomy), must be considered to be of child-bearing potential\n* NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n\nExclusion Criteria:\n\nPRE-REGISTRATION - EXCLUSION CRITERIA:\n\n* Previous exposure to an alternative (investigational) PLK1 inhibitor\n* Demonstration of transformation to acute leukemia on any prior bone marrow biopsy\n* Prior allogeneic hematopoietic stem cell transplantation with active grade 2-4 graft-versus-host disease (GVHD) or with moderate to severe chronic GVHD\n\n  * NOTE: The patient should not have received calcineurin inhibitors ≤28 days prior to pre-registration and should not be actively receiving immunosuppressive therapy for acute or chronic GVHD.\n  * NOTE: CMML or MDS\u002FMPN overlap neoplasms relapse after allogeneic stem cell transplant is allowed as long as they are \\>100 days after transplant and do not have the aforementioned GVHD criteria.\n* Active central nervous system disease\n* 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\n  * NOTE: Precursor states such as monoclonal gammopathy of undetermined significance (MGUS), monoclonal B-cell lymphocytosis (MBL), and indolent lymphoproliferative disorders must be discussed with the Sponsor\u002FPrincipal Investigator.\n* New York Heart Association (NYHA) class III\u002FIV heart failure or active angina\u002Fangina equivalents\n* Anticancer chemotherapy (exception: hydroxyurea) or biologic therapy administered within 2 weeks (and at least 4 elimination half-lives for clinical trial agents) prior to pre-registration. NOTE: Hydroxyurea is allowed for the first 28 days on study. Continuation of hydroxyurea beyond the first cycle must be discussed with the Sponsor\u002FPrincipal Investigator\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Major surgery =\\\u003C 6 weeks prior to pre-registration\n* Gastrointestinal (GI) disorder(s) that, in the opinion of the Investigator, would significantly impede the absorption of an oral agent (eg, intestinal occlusion, active Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)\n* Unable or unwilling to swallow study drug\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, clinically significant nonhealing or healing wounds, clinically significant cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Known active infection with human immunodeficiency virus (HIV) with measurable viral titer, hepatitis B surface antigen positivity, or hepatitis C with measurable viral titer. NOTE: Patients with antibody to hepatitis B core antibody are eligible if they have no measurable viral titer. Patients who have had a hepatitis B virus (HBV) immunization are eligible\n* Patient is receiving any live vaccine (eg, varicella, pneumococcus) =\\\u003C 28 days prior to pre-registration. NOTE: messenger ribonucleic acid (mRNA)-based (eg, Pfizer or Moderna) or replication-deficient virus (eg, Oxford\u002FAstraZeneca) COVID19 vaccines are permitted\n* 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* Any active disease condition that would render the protocol treatment dangerous or impair the ability of the patient to receive study drug\n* Strong CYP3A4 inhibitors\u002Finducers as identified per institutional guidelines\n* QT interval with Fridericia's correction (QTcF) \\> 470 milliseconds. In the case of potentially correctible causes of QT prolongation, (eg, medications, hypokalemia), the electrocardiogram (ECG) may be repeated once during screening and that result may be used to determine eligibility\n\nREGISTRATION - EXCLUSION CRITERIA:\n\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception\n* Increased risk of Torsade des Pointes (TdP) defined as follows:\n\n  * A marked baseline prolongation of QT\u002FQTc interval (eg, repeated demonstration of a QTc interval \\> 480 msec \\[CTCAE Grade \\>= 2\\] using Fredericia's QT correction formula)\n  * A history of additional risk factors for TdP (eg. heart failure, family history of long QT syndrome)\n* Transformation to acute leukemia on registration bone marrow biopsy","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial evaluates the safety, effectiveness, and best dose of onvansertib for the treatment of patients with chronic myelomonocytic leukemia and Myelodysplastic syndrome\u002Fmyeloproliferative neoplasm (MDS\u002FMPN) overlap neoplasms that has come back (recurrent) or that does not respond to treatment (refractory). Onvansertib is a drug that binds to and inhibits an enzyme called PLK1, preventing cancer cell proliferation and causing cell death.",[26,27,28,29,30,31],"Recurrent Chronic Myelomonocytic Leukemia","Refractory Chronic Myelomonocytic Leukemia","Myelodysplastic\u002FMyeloproliferative Neoplasm, Not Otherwise Specified","Recurrent Atypical Chronic Myeloid Leukemia","Recurrent Myelodysplastic\u002FMyeloproliferative Neoplasm","Refractory Myelodysplastic\u002FMyeloproliferative Neoplasm","RECRUITING","2026-06-17",{"date":35,"type":36},"2026-06-22","ACTUAL",{"date":38,"type":36},"2023-04-04",{"date":40,"type":20},"2027-12-01",{"name":42,"class":43},"Mayo Clinic","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"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":52,"type":20},76,[54],"PHASE2","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.",[57,58,26,59,27,60],"Chronic Myelomonocytic Leukemia","Myelodysplastic Syndrome","Recurrent Myelodysplastic Syndrome","Refractory Myelodysplastic Syndrome","2026-05-18",{"date":63,"type":36},"2026-05-20",{"date":65,"type":36},"2020-08-25",{"date":67,"type":20},"2026-12-31",{"name":69,"class":43},"M.D. Anderson Cancer Center",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":87,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":44},"100354542","phase-1-cpx-351-in-treating-patients-with-relapsed-or-refractory-high-risk-myelodysplastic-syndrome-or-chronic-myelomonocytic-leukemia-100354542","NCT03896269","CPX-351 in Treating Patients With Relapsed or Refractory High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia","Phase 1 Dose Escalation Study of CPX-351 for Patients With Int-2 or High Risk IPSS Myelodysplastic Syndromes and Chronic Myelomonocytic Leukemia After Failure to Hypomethylating Agents","Inclusion Criteria:\n\n* Diagnosis of MDS or chronic myelomonocytic leukemia (CMML) according to World Health Organization (WHO)\n* Patients are either not eligible for or choose not to proceed with a stem cell transplant at the time of enrollment\n* MDS and CMML classified by International Prognostic Scoring System (IPSS) as intermediate-2\u002Fhigh risk with excess blasts \\> 5%, or with 10-19% bone marrow blasts\n* No response following at least 4 cycles of therapy or relapse after initial CR, partial response (PR), or HI or progression after any number of cycles of either azacitidine, decitabine, guadecitabine or ASTX727 (oral decitabine) as single agents or in combination with other investigational agents\n* Patient (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* Total bilirubin \\\u003C 3 mg\u002FdL (will allow less than 5 x upper limit of normal \\[ULN\\] if Gilbert's at investigator's discretion)\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =\\\u003C 3 x ULN\n* Serum creatinine clearance \\> 30 mL\u002Fmin and no end\u002Fstage renal disease\n* Hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, granulocyte-colony stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM-CSF\\], procrit, aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) class III or IV congestive heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50 by echocardiogram or multigated acquisition (MUGA) scan\n* History of myocardial infarction within the last 6 months or unstable\u002Funcontrolled angina pectoris or history of severe and\u002For uncontrolled ventricular arrhythmias\n* Uncontrolled infection not adequately responding to appropriate antibiotics\n* Female patients who are pregnant or lactating\n* Patients 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\n* Female patients with reproductive potential who have a positive urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening\n* Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment)\n* Prior cumulative anthracycline exposure of \\> 550 mg\u002Fm\\^2 daunorubicin or equivalent, or \\> 400 mg\u002Fm\\^2 in patients who received radiation therapy to the mediastinum",{"count":78,"type":20},38,[23],"This phase I trial studies best dose and side effects of liposome-encapsulated daunorubicin-cytarabine (CPX-351) and how well it works in treating patients with high risk myelodysplastic syndrome or chronic myelomonocytic leukemia that has come back or has not responded to treatment. Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine, 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.",[82,83,84,26,85,27,86],"Blasts 10-19 Percent of Bone Marrow Nucleated Cells","Blasts More Than 5 Percent of Bone Marrow Nucleated Cells","High Risk Chronic Myelomonocytic Leukemia","Recurrent High Risk Myelodysplastic Syndrome","Refractory High Risk Myelodysplastic Syndrome",{"date":63,"type":36},{"date":89,"type":36},"2019-05-14",{"date":91,"type":20},"2027-12-31",{"name":69,"class":43},{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":130,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":44},"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","80 Years",{"count":102,"type":20},24,[23],"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.",[106,107,108,109,110,111,112,113,114,59,115,60,116,117,118,119,120,121,58,122,123,124,125,57,126,26,127,128,129],"Juvenile Myelomonocytic Leukemia","Recurrent Acute Biphenotypic Leukemia","Recurrent Acute Undifferentiated Leukemia","Recurrent Childhood Acute Lymphoblastic Leukemia","Recurrent Childhood Acute Myeloid Leukemia","Refractory Acute Lymphoblastic Leukemia","Refractory Adult Acute Lymphoblastic Leukemia","Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm","Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Undifferentiated Leukemia","Mixed Phenotype Acute Leukemia","Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive","Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive","Recurrent Acute Lymphoblastic Leukemia","Recurrent Acute Myeloid Leukemia","Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Acute Biphenotypic Leukemia","Chronic Myeloid Leukemia","Minimal Residual Disease","Recurrent Mixed Phenotype Acute Leukemia","Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive",[131,132,133,128],"HA-1","TCR","Immunotherapy","2026-05-15",{"date":61,"type":36},{"date":137,"type":36},"2018-02-23",{"date":139,"type":20},"2028-07-16",{"name":141,"class":43},"Fred Hutchinson Cancer Center",{"id":143,"slug":144,"hasResults":11,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":149,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":21,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":44},"100587459","phase-1-chemotherapy-decitabine-in-combination-with-flag-ida-and-total-body-irradiation-followed-by-donor-stem-cell-transplant-for-the-treatment-of-adults-with-myeloid-malignancies-at-high-risk-of-relapse-100587459","NCT06928662","Chemotherapy (Decitabine in Combination With FLAG-Ida) and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Adults With Myeloid Malignancies at High Risk of Relapse","Sequential Decitabine in Combination With FLAG-Ida Followed Immediately by Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation (DEC-FLAG-Ida\u002FRIC) for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1\u002F2 Study","Inclusion Criteria:\n\n* Age ≥ 18 years with an HCT-co-morbidity index (CI) ≤ 5 for patients over 60 years.\n* AML (2022 World Health Organization \\[WHO\\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy, 1 cycle of high-dose cytarabine-based chemotherapy, or at least 2 cycles of venetoclax in combination with other therapies) or is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphologic remission (i.e. \\\u003C 5% blasts in the bone marrow) but evidence of minimal residual disease (MRD) by multiparameter flow cytometry, cytogenetics\u002Ffluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation. Patients with relapsed or refractory acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia) that is either primary refractory or is in untreated or unsuccessfully treated first or subsequent relapse are also eligible.\n* MDS and CMML: Subjects with previously treated MDS and CMML, defined as prior treatment with at least one hypomethylating agent (hypomethylating agent \\[HMA\\]; azacitidine, decitabine and\u002For decitabine-cedazuridine) whose disease progressed, relapsed, or was refractory to HMA treatment as follows: 1) patients who have failed at least 4 cycles of monotherapy with azacitidine, decitabine or decitabine-cedazuridine, 2) patients who received at least 2 cycles of HMA in combination with another therapeutic agent. Subjects with MDS and CMML who failed at least 1 cycle of induction chemotherapy will be also eligible. Patients with MDS or CMML who progress to secondary AML will be eligible if they received at least 4 cycles of HMA alone or 2 cycles of HMA in combination with another therapeutic agent.\n* Patients may have previously received hypomethylating agents or chemotherapy with a mitoxantrone, idarubicin- or cladribine\u002Ffludarabine-based regimen for MDS or AML. If the patient has received cladribine-cytarabine-filgrastim-mitoxantrone (CLAG-M) or FLAG-Ida before and has been sensitive to this regimen, defined as MRD negative complete remission (CR) immediately after receiving the treatment and which lasts ≥ 1 year, eligibility will be determined on a case-by-case basis by the study principal investigator (PI).\n* The use of hydroxyurea prior to initiation of study treatment is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, white blood cells (WBC) \\> 100,000\u002FμL or with concern for other complications of high tumor burden of high tumor dynamics (e.g. disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 per dose) prior to start of study treatment.\n* Karnofsky score ≥ 70; Eastern Cooperative Oncology Group (ECOG) 0-1.\n* Adequate cardiac function defined as absence of decompensated congestive heart failure and\u002For uncontrolled arrhythmia and left ventricular ejection fraction ≥ 45%.\n* Bilirubin ≤ 2.5 x Institutional Upper Limit of Normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and either diffusion capacity of the lung for carbon monoxide (DLCO) corrected ≥ 70%mmHg or DLCO corrected 60-69%mmHg and partial pressure of oxygen (pO2) ≥ 70mmHg.\n* Creatinine clearance \\> 60 mL\u002Fmin.\n* Prior autologous HCT is permissible if relapse occurred \\> 6 months after HCT.\n* Prior TBI-containing allogeneic HCT up to 3 Gy is permissible if \\> 6 months after HCT.\n* A human leukocyte antigen (HLA)-matched sibling\u002Funrelated donor, mismatched unrelated donor or haploidentical donor for collection of stimulated peripheral blood stem cells must be identified and readily available.\n* Ability to understand and sign a written informed consent document (or legal representative).\n* SIBLING 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* MATCHED UNRELATED DONOR: Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR 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* MATCHED UNRELATED DONOR: 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* MATCHED UNRELATED DONOR: 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* MISMATCHED UNRELATED DONOR: HLA-matching must be based on results of high resolution typing at HLA-A, -B, -C, -DRB1, and -DQ.\n* MISMATCHED UNRELATED DONOR: Mismatch for one HLA class I antigen with or without an additional mismatch for one HLA-class I allele but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: Mismatched for two HLA class I alleles but matched for HLA-DRB1 and HLA-DQ.\n* MISMATCHED UNRELATED DONOR: HLA class I HLA-A, -B, -C allele matched donors allowing for any one or two DRB1 and\u002For DQB1 antigen\u002Fallele mismatch.\n* MISMATCHED UNRELATED DONOR: If the patient is homozygous at the mismatch HLA class I locus or II locus, the donor must be heterozygous at that locus and one allele must match the patient (i.e., patient is homozygous A\\*01:01 and donor is heterozygous A\\*01:01, A\\*02:01). This mismatch will be considered a one-antigen mismatch for rejection only.\n* HAPLOIDENTICAL 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* HAPLOIDENTICAL DONOR: Age ≥ 18 years.\n* HAPLOIDENTICAL DONOR: Weight ≥ 40 kg.\n* HAPLOIDENTICAL DONOR: Donor must meet the 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 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* DONOR: Donors will undergo diagnostic evaluation (clinical, laboratory test and imaging) as indicated per institutional guidelines.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) disease.\n* Concomitant illness associated with a likely survival of \\\u003C 1 year.\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with antimicrobials and\u002For controlled or stable. Patients with fever thought to be likely secondary to myeloid malignancy are eligible.\n* Known hypersensitivity or contraindication to any study drug used in this trial.\n* Pregnancy or lactation.\n* Concurrent treatment with any other approved or investigational anti-leukemia agent.\n* HAPLOIDENTICAL DONOR: Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patient with DSA mean fluorescent intensity (MFI) \\\u003C 5000 after desensitization treatment, will be considered eligible to participate in the study.",true,{"count":151,"type":20},36,[23,54],"This phase I\u002FII trial studies the safety, side effects, and best dose of decitabine in combination with fludarabine, cytarabine, filgrastim, and idarubicin (FLAG-Ida) and total body irradiation (TBI) followed by a donor stem cell transplant in treating adult patients with cancers of blood-forming cells of the bone marrow (myeloid malignancies) that are at high risk of coming back after treatment (relapse). Cancers eligible for this trial are acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The FLAG-Ida regimen consists of the following drugs: fludarabine, cytarabine, filgrastim, and idarubicin. These are chemotherapy drugs that 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. Filgrastim is in a class of medications called colony-stimulating factors. It works by helping the body make more neutrophils, a type of white blood cell. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TBI is radiation therapy to the entire body. Giving chemotherapy and TBI before a donor peripheral blood stem cell (PBSC) transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. Giving decitabine in combination with FLAG-Ida and TBI before donor PBSC transplant may work better than FLAG-Ida and TBI alone in treating adult patients with myeloid malignancies at high risk of relapse.",[122,116,117,121,108,26,127,59,155,156,27,157,60,158],"Refractory Acute Myeloid Leukemia","Refractory Acute Undifferentiated Leukemia","Refractory Mixed Phenotype Acute Leukemia","Secondary Acute Myeloid Leukemia","2026-05-13",{"date":134,"type":36},{"date":162,"type":36},"2025-09-23",{"date":164,"type":20},"2028-11-29",{"name":141,"class":43},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":44},"100373289","phase-1-azacitidine-venetoclax-and-gilteritinib-in-treating-patients-with-recurrentrefractory-flt3-mutated-acute-myeloid-leukemia-chronic-myelomonocytic-leukemia-or-high-risk-myelodysplastic-syndromemyeloproliferative-neoplasm-100373289","NCT04140487","Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent\u002FRefractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome\u002FMyeloproliferative Neoplasm","A Phase I\u002FII Study of Azacitidine, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation","Inclusion Criteria:\n\n* Diagnosis:\n\n  * Phase I cohort: Adults ≥ 18 years with relapsed\u002Frefractory FLT3-mutated AML or CMML or other MDS\u002FMPN that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * Phase II cohort A: Adults ≥ 18 years with newly diagnosed FLT3-mutated AML\n  * Phase II cohort B: Adults ≥ 18 years with relapsed\u002Frefractory FLT3-mutated AML or CMML or other MDS\u002FMPN that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * For all cohorts, patients with either FLT3-internal tandem duplication (FLT3-ITD) or FLT3 D835 mutations will be eligible\n* Performance status ≤ 3 (Eastern Cooperative Oncology Group \\[ECOG\\] scale)\n* Total serum bilirubin ≤ 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the principal investigator (PI)\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI\n* Creatinine clearance ≥ 30 mL\u002Fmin\n* Ability to swallow\n* Signed informed consent\n\nExclusion Criteria:\n\n* Prior therapies:\n\n  * Phase I cohort: No restriction based on prior therapies\n  * Phase II cohort A: Patients with prior therapy for AML are not eligible. Prior therapy for antecedent hematologic disorder is allowed. Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed\n  * Phase II cohort B: No restriction on number of prior therapies\n* Patients suitable for and willing to receive intensive induction chemotherapy (for Phase II cohort A only)\n* Congenital long QT syndrome or corrected QT interval by Fridericia (QTcF) \\> 450 msec. Repeat electrocardiograms (EKGs) after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria. In cases where QTcF \\> 450 msec is considered to be falsely increased due to inaccurate automated reading and not clinically significant (e.g. due to bundle branch block), patients are still eligible if cardiologist reviews and documents that QTcF is ≤ 450 msec when manually measured\n* Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment)\n* Active grade III-V cardiac failure as defined by the New York Heart Association criteria\n* Active central nervous system leukemia\n* Known human immunodeficiency virus (HIV) seropositive\n* Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\n\n  * Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI\n* Consumed strong inducer of cytochrome P450, family 3, subfamily A (CYP3A) or p-glycoprotein within 3 days of study enrollment. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wort\n* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea and\u002For cytarabine (given for cytoreduction) permitted\n* Pregnant women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 4 months after the last dose of study drugs. Lactating women (or those planning to breastfeed) should not breastfeed during treatment of gilteritinib and for at least 2 months after the last dose of gilteritinib",{"count":174,"type":20},97,[23,54],"This phase I\u002FII trial studies the side effects and best dose of gilteritinib and to see how well it works in combination with azacitidine and venetoclax in treating patients with FLT3-mutation positive acute myeloid leukemia, chronic myelomonocytic leukemia, or high-risk myelodysplastic syndrome\u002Fmyeloproliferative neoplasm that has come back (recurrent) or has not responded to treatment (refractory). Drugs used in chemotherapy, such as azacitidine, 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. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and gilteritinib may work better compared to azacitidine and venetoclax alone in treating patients with acute myeloid leukemia, chronic myelomonocytic leukemia, or myelodysplastic syndrome\u002Fmyeloproliferative neoplasm.",[121,26,30,155,27,31],"2026-04-13",{"date":180,"type":36},"2026-04-16",{"date":182,"type":36},"2019-12-17",{"date":184,"type":20},"2028-09-01",{"name":69,"class":43},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":44},"100391334","phase-1-clag-m-or-flag-ida-chemotherapy-and-reduced-intensity-conditioning-donor-stem-cell-transplant-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-myelodysplastic-syndrome-or-chronic-myelomonocytic-leukemia-100391334","NCT04375631","CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia","CLAG-M or FLAG-Ida Chemotherapy Followed Immediately by Related\u002FUnrelated Reduced-Intensity Conditioning (RIC) Allogeneic Hematopoietic Cell Transplantation for Adults With Myeloid Malignancies at High Risk of Relapse: A Phase 1 Study","Inclusion Criteria:\n\n* Age \\>= 18 years with an Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) =\\\u003C 5 for patients over 60 years -(Enrollment of patients \\>= 75 years of age will require case presentation at the transplant Patient Care Conference (PCC) and approval by consensus)\n* Acute myeloid leukemia (AML) (2016 World Health Organization \\[WHO\\] criteria) that is either primary refractory (as defined by failure of 2 cycles of 7+3-like chemotherapy, 1 cycle of high-dose cytarabine-based chemotherapy, or at least 2 cycles of venetoclax in combination with other therapies), or is in untreated or unsuccessfully treated first or subsequent relapse. Patients in morphological remission (i.e. \\\u003C 5% blasts in the bone marrow) but evidence of minimal residual disease (MRD) by multiparameter flow cytometry, cytogenetics\u002Ffluorescence in situ hybridization (FISH), or molecular means will be eligible for trial participation. Patients with relapsed or refractory acute leukemia of ambiguous lineage (acute undifferentiated leukemia, mixed phenotype acute leukemia) that is either primary refractory or is in untreated or unsuccessfully treated first or subsequent relapse are also eligible\n* Subjects with previously treated myelodysplastic syndrome (MDS) and chronic myelomonocytic leukemia (CMML), defined as prior treatment with at least one hypomethylating agent (HMA; azacitidine and\u002For decitabine) whose disease progressed, relapsed, or was refractory to HMA treatment as follows: 1) patients who have failed at least 4 cycles of monotherapy with azacitidine or decitabine, 2) patients who received at least 2 cycles of HMA in combination with another therapeutic agent. Subjects with MDS and CMML who failed at least 1 cycle of induction chemotherapy will be also eligible\n* The use of hydroxyurea prior to initiation of study treatment is allowed. Patients with symptoms\u002Fsigns of hyperleukocytosis, WBC \\> 100,000\u002FuL or with concern for other complications of high tumor burden (e.g. disseminated intravascular coagulation) can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 per dose) prior to start of study treatment\n* Karnofsky score \\>= 70; Eastern Cooperative Oncology Group (ECOG) 0-1\n* Adequate cardiac function defined as absence of decompensated congestive heart failure and\u002For uncontrolled arrhythmia and left ventricular ejection fraction \\>= 45%\n* Bilirubin =\\\u003C 2.5 x institutional upper limit of normal unless elevation is thought to be due to hepatic infiltration by AML, Gilbert's syndrome, or hemolysis\n* Adequate pulmonary function defined as absence of oxygen (O2) requirements and either carbon monoxide diffusing capability test (DLCO) correct \\>= 70% mmHg or DLCO corrected 60-69% mmHg and partial pressure of oxygen (pO2) \\>= 70 mmHg\n* Serum creatinine =\\\u003C 1.5 mg\u002FdL\n* Prior autologous HCT is permissible if relapse occurred \\> 3 months but =\\\u003C 6 months after HCT\n* Prior TBI-containing allogeneic HCT up to 3 Gy is permissible if \\> 6 months after HCT\n* A human leukocyte antigen (HLA)-matched or near-matched related, unrelated or haploidentical donor for collection of stimulated peripheral blood stem cells or HLA-matched or near-matched cord blood unit must be identified and readily available\n* Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 12 months post-transplant\n* Patients may have previously received chemotherapy with a mitoxantrone, idarubicin- or cladribine\u002Ffludarabine-based regimen for MDS or AML. If the patient has received CLAG-M or FLAG-Ida before and has been sensitive to this regimen, eligibility will be determined on a case-by-case basis by the study principal investigator (PI)\n* Ability to understand and sign a written informed consent document (or legal representative)\n* DONOR: Patients must have an HLA-matched related donor or an HLA-matched unrelated donor, or haploidentical donor who meets standard FHCC and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) 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* Haploidentical donor:\n\n  * 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  * Age ≥ 12 years\n  * Weight ≥ 40 kg.\n  * 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 must meet the 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  * 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      * i. RBC cross match compatible\n      * ii. Minor ABO incompatibility\n      * iii. Major ABO incompatibility\n\nExclusion Criteria:\n\n* Patients \\>= 18 years being treated at Seattle Children's Hospital\n* Active central nervous system (CNS) disease\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active systemic fungal, bacterial, viral, or other infection, unless disease is under treatment with anti-microbials and\u002For controlled or stable. Patients with fever thought to be likely secondary to myeloid malignancy are eligible\n* Known hypersensitivity or contraindication to any study drug used in this trial\n* Pregnancy or lactation\n* Concurrent treatment with any other approved or investigational anti-leukemia agent\n* Haploidentical donor exclusion criteria:\n\n  * Since detection of anti-donor-specific antibodies (anti-DSA) is associated with higher graft rejection rate, patients will be screened for anti-DSA pre-transplant. Patient with DSA mean fluorescent intensity (MFI) \\\u003C5000 after desensitization treatment, will be considered eligible to participate in the study.",{"count":194,"type":20},120,[23],"This phase I trial studies the best dose of total body irradiation when given with cladribine, cytarabine, filgrastim, and mitoxantrone (CLAG-M) or idarubicin, fludarabine, cytarabine and filgrastim (FLAG-Ida) chemotherapy reduced-intensity conditioning regimen before stem cell transplant in treating patients with acute myeloid leukemia, myelodysplastic syndrome, or chronic myelomonocytic leukemia that has come back (relapsed) or does not respond to treatment (refractory). Giving chemotherapy and total body irradiation before a donor peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When the healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets and may help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can attack the body's normal cells called graft versus host disease. Giving cyclophosphamide, cyclosporine, and mycophenolate mofetil after the transplant may stop this from happening.",[121,26,59,155,27,157,60,198,156],"Refractory Acute Leukemia of Ambiguous Lineage","2026-03-03",{"date":201,"type":36},"2026-03-05",{"date":203,"type":36},"2020-12-03",{"date":205,"type":20},"2027-03-17",{"name":141,"class":43},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100570866","phase-1-q702-for-the-treatment-of-patients-with-hematologic-malignancies-100570866","NCT06712810","Q702 for the Treatment of Patients With Hematologic Malignancies","MC220806: Phase I Study Evaluating the Efficacy of CSF1R and TAM Receptor or Inhibition in Hematologic Malignancies With Q702, a Small Molecular Inhibitor","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Not eligible for or have failed therapies with established benefits, at the discretion of the treating physician\n* PRE-REGISTRATION: Patients must meet one of the following criteria:\n\n  * Relapsed\u002Frefractory patients with Erdheim-Chester disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis without activating alterations in v-Raf murine sarcoma viral oncogene homolog B (BRAF) or Mitogen-activated protein kinase kinase (MAP2K) oncogenes who have progressed after first line of therapy.\n\n    * Note: Relapsed is defined as a relapse that occurred after having a response to the last therapy at any point during the treatment. Refractory is no response (stable disease or progressive disease while on therapy) to a given treatment at least after 1 month of being on the given treatment.\n  * Newly diagnosed patients with Rosai-Dorfman disease without activating alterations in MAP2K oncogenes.\n  * Relapsed\u002Frefractory patients with Rosai-Dorfman disease and an activating mitogen-activated protein kinase (MAPK) pathway alteration who have failed prior treatment with cobimetinib.\n  * Relapsed\u002Frefractory patients with Erdheim-Chester disease or Langerhans histiocytosis who have received vemurafenib for BRAF V600E mutated disease or cobimetinib for disease with activating MAP2K alterations.\n  * Patients with Erdheim-Chester disease, Rosai-Dorfman disease, Langerhans histiocytosis, histiocytic sarcoma, or another malignant histiocytosis who cannot tolerate or have a contraindication to BRAF or MEK inhibitors or those who cannot have reliable access to these inhibitors due to financial restraints or geographic location or initiation of BRAF or mitogen-activated protein kinase kinase (MEK) inhibitors is futile based on the genomic alterations or the discretion of treating physician.\n  * Relapsed\u002Frefractory higher risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF).\n\n    * Note: MF patients must have failed ≥ 1 of the 4 Food and Drug Administration (FDA)-approved Janus kinase (JAK) Inhibitors for MF (i.e. ruxolitinib, fedratinib, pacritinib, momelotinib) to be eligible. MDS and CMML patients must have failed hypomethylating agent-based therapy, if eligible.\n    * Note: Higher risk is defined as intermediate or higher risk by international prognostic scoring system (IPSS-R) or moderate high or higher risk as per molecular internal prognostic scoring system (IPSS-M).\n  * T cell lymphoma (peripheral and cutaneous), or mantle cell lymphomas. Patients must have failed ≥ 2 lines of therapy.\n  * Primary central nervous system (CNS) lymphoma who has failed ≥ 2 lines of therapy.\n  * Relapsed or refractory follicular lymphoma; or Waldenstrom macroglobulinemia\u002Flymphoplasmacytic lymphoma. Must have failed ≥ 2 lines of therapy.\n  * Patients with Waldenström macroglobulinemia who have received or are not eligible for a Bruton tyrosine kinase (BTK)-inhibitor therapy.\n  * Relapsed or refractory chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL) who have failed ≥ 2 lines of therapy and have been treated with at least one prior line of a BTK inhibitor and\u002For a B-cell lymphoma 2 (BCL2) inhibitor. Need documented CLL\u002FSLL requiring treatment according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines 2018.\n\n    * NOTE: Use of oral steroids up to 20 mg of daily will be allowed for patients who are discontinuing BTK inhibitors just prior to the registration. This is not mandatory and should be done at the discretion of patient's treating physician.\n\n      * Note: All patients in the above disease groups may be on corticosteroids at the investigator's discretion\n* PRE-REGISTRATION: Histopathological or cytological confirmation of diseases\n* PRE-REGISTRATION: Willingness to provide mandatory blood, bone marrow aspirate, saliva, and tissue specimens for correlative research, as applicable to the disease site\n* PRE-REGISTRATION: Ability to swallow pills\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* REGISTRATION: Life expectancy of ≥ 3 months\n* REGISTRATION: Measurable or assessable disease:\n\n  * For histiocytic neoplasms and lymphoma-measurable disease is defined as measurable by CT (dedicated CT or the CT portion of a PET\u002FCT) or MRI: To be considered measurable, there must be at least one lesion that has a single diameter of ≥ 1.5 cm for non-CNS disease. For CNS involved disease, MRI confirmation with any size would be appropriate.\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\u002FCT are also eligible as long as the assessable disease is biopsy proven lymphoma or histiocytic\u002Fdendritic cell neoplasms.\n  * For all other eligible diseases listed-N\u002FA\n* REGISTRATION: Hemoglobin ≥ 8.0 g\u002FdL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1.0 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 80 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: White blood cell (WBC) ≥ 2.5 x 10\\^9\u002FL (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Alanine aminotransferase (ALT), aspartate transaminase (AST), and alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Serum creatinine of ≤ 1.5 x ULN and calculated creatinine clearance of ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration)\n* REGISTRATION: Negative urine or serum pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n* REGISTRATION: Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug.\n\n  * Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 2 years postmenopausal; or injectable or implantable agent\u002Fdevice\n* REGISTRATION: Provide written informed consent\n* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance\n* REGISTRATION: Willing to return to the enrolling institution for follow-up (during the Active Monitoring Phase of the study).\n\nExclusion Criteria:\n\n* PRE-REGISTRATION: Myeloproliferative neoplasm (MPN) patients with known active CNS metastases and\u002For carcinomatous meningitis.\n\n  * Note: Histiocytosis and lymphoma patients who are on steroids are allowed to enroll\n* REGISTRATION: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n* REGISTRATION: New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary\u002Fperipheral artery bypass graft, congestive heart failure ≤ 6 months prior to registration\n* REGISTRATION: Corrected QT interval (using Fridericia's correction formula) (QTcF) of \\> 470 msec\n* REGISTRATION: Known active infection with human immunodeficiency virus (HIV), Human T-lymphotropic virus 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV):\n\n  * Active infection with (HIV) and CD4+ T-cell count \\\u003C 350 μL.\n  * Patients with a detectable HIV viral load and not on antiretroviral therapy (ART) for ≥ 4 weeks.\n  * Exceptions:\n\n    * Patients with a history of hepatitis B or C are allowed if HBV deoxyribonucleic acid (DNA) or HCV ribonucleic acid (RNA) are undetectable.\n    * Patients with active HIV infection and CD4+ T-cell count ≥ 350 μL who are on active antiretroviral treatment\n* REGISTRATION: Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n* REGISTRATION: Concomitant use of strong inhibitors and inducers of CYP1A2, CYP2C19, CYP2D6, and strong inhibitors and inducers of CYP3A4 within five half-lives of the active drug prior to registration and throughout the trial.\n\n  * Note: Strong inhibitors and inducers of CYP3A4 should be discontinued for five half-lives of the active drug prior to starting study drug and avoided throughout the trial\n* REGISTRATION: Concomitant use of any herbal supplements.\n\n  * Note: Supplements taken prior to starting study drug should be discussed with the Principal Investigator as varied washout periods may be clinically indicated and necessary\n* REGISTRATION: Any of the following prior therapies used as primary cancer treatment:\n\n  * Targeted therapeutics other than monoclonal antibodies (e.g., kinases inhibitors) ≤ 2 weeks prior to registration.\n  * Monoclonal antibodies ≤ 6 weeks, or ≥ 5 half-life, whichever is shorter, prior to registration.\n  * Chemotherapy ≤ 4 weeks prior to registration (6 weeks for nitrosoureas or Mitomycin C.\n  * Surgery ≤ 4 weeks prior to registration\n  * Any investigational therapy ≤ 4 weeks prior to registration\n  * Radiation therapy ≤ 4 weeks prior to registration\n\n    * Exceptions:\n\n      * Palliative radiation therapy ≥ 2 weeks prior to registration for control of tumor mass related symptoms (e.g., pain control from a discrete bone metastasis) allowed, unless the radiation field includes organs for which the radiation therapy could result in certain direct organ toxicities (e.g., radiation induced esophagitis), which could complicate the interpretation of the Q702 safety profile.\n      * Radiation induced toxicities which could interfere with the interpretation of the Q702 safety profile should recover to ≤ grade 1 before registration.\n      * Patients receiving palliative radiation intended to reduce the risk of a potential pathological fracture should be allowed ≥ 4 weeks from the last radiation therapy treatment to recover from any radiation induced toxicity and to allow for an adequate period of observation relative to the potential risk of a pathological fracture\n* REGISTRATION: Failure to recover from acute, reversible effects of prior therapy to ≤ grade 1 or patient baseline prior to registration.\n\n  * NOTE: Patient with chronic effects such as neuropathy, fatigue, keratitis\u002Fkeratopathy, anorexia, etc. are allowed\n* 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* REGISTRATION: Active retinal pigment epithelium (RPE)\u002Fphotoreceptor disorders such as retinitis pigmentosa, cone-rod dystrophies, Bests dystrophy, Stargardt disease (STGD), macular degeneration, retinal detachment, and opaque cornea. Exceptions:\n\n  * Mild blurry vision, either age-related or due to ocular or systemic disorder (e.g., diabetes, dry eyes, cataracts, uncorrected refraction abnormality) may be allowed at the discretion of the ophthalmologist if deemed as not constituting evidence of pre-existing retinopathy (e.g., severe nonproliferative or proliferative diabetes retinopathy) or a condition with the potential to cause a predisposition to drug-induced retinopathy. \\[e.g., severe retinal vascular disease with scattered intraretinal hemorrhages, cotton wool-spots and intraretinal microvascular abnormalities (IRMA)\\]\n  * Patients with only one assessable eye and no evidence of pre-existing retinopathy may be allowed at the discretion of the principal investigator\n* REGISTRATION: Active second malignancy requiring treatment that would interfere with the assessment of the response of the primary cancer or interpretation of the safety of this protocol therapy",{"count":215,"type":20},46,[23],"This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and\u002For effective in treating patients with hematologic malignancies.",[219,220,221,222,223,224,26,225,226,227,59,228,229,230,231,27,232,233,234,235,60,236,237,238,239,240,114,241,242,243,244,245,115,246,247,248,249],"Hematopoietic and Lymphatic System Neoplasm","Histiocytic Sarcoma","Malignant Histiocytosis","Peripheral T-Cell Lymphoma, Not Otherwise Specified","Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent Chronic Lymphocytic Leukemia","Recurrent Follicular Lymphoma","Recurrent Langerhans Cell Histiocytosis","Recurrent Lymphoplasmacytic Lymphoma","Recurrent Myelofibrosis","Recurrent Small Lymphocytic Lymphoma","Recurrent Waldenstrom Macroglobulinemia","Refractory Chronic Lymphocytic Leukemia","Refractory Erdheim-Chester Disease","Refractory Follicular Lymphoma","Refractory Langerhans Cell Histiocytosis","Refractory Lymphoplasmacytic Lymphoma","Refractory Myelofibrosis","Refractory Small Lymphocytic Lymphoma","Refractory Waldenstrom Macroglobulinemia","Rosai-Dorfman-Destombes Disease","Primary Central Nervous System Lymphoma","Recurrent Erdheim-Chester Disease","Recurrent Fibroblastic Reticular Cell Sarcoma","Recurrent Histiocytic Sarcoma","Recurrent Interdigitating Dendritic Cell Sarcoma","Recurrent Rosai-Dorfman-Destombes Disease","Refractory Fibroblastic Reticular Cell Sarcoma","Refractory Histiocytic Sarcoma","Refractory Interdigitating Dendritic Cell Sarcoma","Refractory Rosai-Dorfman-Destombes Disease","2025-10-08",{"date":252,"type":36},"2025-10-10",{"date":254,"type":36},"2025-08-27",{"date":256,"type":20},"2030-09-15",{"name":42,"class":43},2]