[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-myeloid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-myeloid":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,49,80,112,132,160,183,232,259,287],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100450311","phase-2-asciminib-as-initial-therapy-for-patients-with-chronic-myeloid-leukemia-in-chronic-phase-100450311",false,"NCT05143840","Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase","Asciminib as Initial Therapy With Addition of Lower Dose Tyrosine Kinase Inhibitors for Patients With Chronic Myeloid Leukemia Who do Not Achieve Optimal Response or a Deep Molecular Remission (ALERT CML)","ALERTCML","Inclusion Criteria:\n\n1. Age ≥18 years old\n2. Willing and able to give informed consent\n3. Newly diagnosed with CML in chronic phase within 6 months from confirmed diagnosis via bone marrow biopsy\u002Faspirate and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR::ABL1 protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility.\n4. Minimal prior CML therapy with a TKI for less than or equal to 30 days. Treatment with hydroxyurea, busulfan, anagrelide or other non-specific chemotherapy agents is allowed with no time restrictions within the eligible time from diagnosis.\n5. ECOG performance status 0-2 (appendix 1)\n6. Adequate organ function:\n\n   * AST and ALT \\\u003C 3 times the institutional upper limit of normal (ULN)\n   * eGFR ≥ 30 mL\u002Fmin as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine equation (https:\u002F\u002Fwww.kidney.org\u002Fprofessionals\u002Fkdoqi\u002Fgfr\\_calculator)\n   * Total bilirubin \\\u003C 1.5 times the institutional ULN or \\\u003C 3.0 x the institutional ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits)\n7. Adequately controlled blood pressure, defined as systolic blood pressure of \\\u003C140 mmHq and diastolic of \\\u003C90 mmHg, at the time of enrollment.\n8. Lipase ≤ 1.5 x ULN. For lipase \\> ULN - ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis.\n9. Creatine phosphokinase \\\u003C 2.5 x ULN\n10. Female patients must meet one of the following:\n\n    1. Postmenopausal for at least one year before the screening visit,\n    2. Surgically sterile\n    3. If they are of childbearing potential, agree to practice two effective methods of contraception from the time of signing of the informed consent form through 90 days after the last dose of study drug,\n    4. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable\n    5. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.)\n11. Male patients, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the following:\n\n    1. Practice effective barrier contraception during the entire study treatment period and through 90 days after the last study drug dose\n    2. Must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable\n    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n\nExclusion Criteria:\n\n1. Patients with accelerated or blast phase CML (refer to appendix 4)\n2. Active second malignancy requiring active treatment\n3. History of recent (within 12 months) acute pancreatitis or chronic pancreatitis\n4. Subjects who have previously received treatment with asciminib.\n5. Subjects with PLT count \\\u003C 50,000 mm3 or ANC of \\\u003C 500 mm3 or Hemoglobin \\\u003C 8 g\u002FdL\n6. Cardiac or cardiac repolarization abnormality, including any of the following:\n\n   1. History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)\n   2. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)\n   3. QTcF at screening greater than or equal to 450 msec (male patients), greater than or equal to 460 msec (female patients) unless patient has a pacemaker\n   4. Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:\n\n   i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant\u002Fsymptomatic bradycardia ii. Concomitant medication(s) with a \"Known risk of Torsades de Pointes\" per wwwcrediblemeds.org\u002F that cannot be discontinued or replace 7 days prior to starting study drug by safe alternative medication.\n\n   iii. Inability to determine the QTcF interval\n7. Pregnant or lactating\n8. Taking a strong inhibitors or inducers of CYP3A4 or CYP3A4 substrates with narrow therapeutic index (refer to appendix 6) at time of enrollment\n9. Unable to comply with lab appointment schedule and PRO assessments\n10. Another investigational drug within 4 weeks of enrollment\n11. Any serious medical or psychiatric illness that could, in the investigator's opinion, interfere with the completion of treatment according to this protocol\n12. Patient has undergone a prior allogeneic stem cell transplant\n13. Known clinical history of active HBV infection","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used:\n\n1. Dasatinib 50 mg daily\n2. Imatinib 300 mg daily\n3. Nilotinib 300 mg daily\n\nPatients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.",[27,28,29,30],"Chronic Myeloid Leukemia, Chronic Phase","Adult CML","Leukemia, Myeloid","Leukemia,Myeloid, Chronic",[32,28,33,34,35],"Chronic Myeloid Leukemia","tyrosine kinase inhibitors","H. Jean Khoury Cure CML Consortium","HJKC3-0004","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":40},"2022-04-22",{"date":44,"type":21},"2032-02",{"name":46,"class":47},"University of Alabama at Birmingham","OTHER",8,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100526733","phase-1-preemptive-ciml-nk-cell-therapy-after-hematopoietic-stem-cell-transplantation-100526733","NCT06138587","Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation","Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I\u002FIb Clinical Trial","Inclusion Criteria for Trial Enrollment:\n\n* Histologically or cytologically confirmed diagnosis of AML, MDS, or MDS\u002FMPN that is at high risk for post-transplant relapse and that has measurable disease prior to transplant. Patients at high risk for post-transplant relapse include:\n\n  * De novo AML diagnosed at or after age 60, except CBF AML\n  * De novo AML in CR1 AND MRD+ by Hematologics Inc. flow cytometry pretransplant (this would be on the most recent pre-transplant bone marrow)\n  * Secondary AML\n  * AML with 5 - \\> 10% blasts at the time of transplant who are judged by their treating clinician and study PI to have no benefit from additional pre-transplant chemotherapy\n  * Any AML transplanted in CR2 or greater\n  * TP53-mutated MDS or AML\n  * Therapy-related MDS or AML\n  * MDS with monosomy 7\n  * MDS with \\>= 5% blasts at the time of transplant\n  * MDS\u002FMPN or CMML\n* Adequate organ function within 2 weeks of NK cell infusion as defined below (should correspond with admission for SCT):\n\n  * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * Serum creatinine \\\u003C\u002F= 2.0mg\u002FdL\n  * O2 saturation: ≥90% on room air\n  * LVEF \\>40%. If there is no clinical evidence of a change in cardiovascular function from the time of pre-transplantation ECHO (per FACT standards should be performed within 6 weeks of stem cell infusion), then there is no need to repeat it. Otherwise, an ECHO will need to be repeated.\n* Adult patients (age ≥ 18) eligible for and planned to undergo a standard-of-care reduced intensity conditioning (RIC) HLA-matched related or related haploidentical allogeneic stem cell transplant using PTCY-based GVHD prophylaxis. All eligibility criteria and workups for undergoing SOC allogeneic SCT for the recipient and donor will be based on institutional standards and SOPs.\n* For patients with AML, the disease must meet criteria for CR\u002FCri according to 2017 ELN guidelines, or have 5-10% blasts at the time of the transplant and in the judgement of their primary BMT clinician and study PI to have no benefit from additional pre-transplant chemotherapy. For patients with MDS or MDS\u002FMPN, the blast percentage on the bone marrow aspirate and biopsy must be less than 10%.\n* The same related donor is available to provide a non-mobilized apheresis product after the stem-cell donation.\n* ECOG performance status \\\u003C= 2 (Karnofsky \\>= 60%, see Appendix C).\n* Negative pregnancy test for women of childbearing age\n* The effects of CIML NK cells combined with IL-2 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after IL-2 dose administration.\n* No laboratory evidence of ongoing hemolysis in opinion of investigator\n\nExclusion Criteria Trial Enrollment:\n\n* Adult participants who are eligible for and who would be expected to have a greater benefit from myeloablative conditioning in their SOC allo HSCT as judged by their treating physician\n* Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.\n* Extramedullary leukemia involving sanctuary sites not readily accessible to immune surveillance, such as CNS or testis. Other sites of extramedullary relapse (e.g., leukemia cutis, granulocytic sarcoma) are acceptable.\n* The planned use of sirolimus for GVHD prophylaxis would result in exclusion of the patient from the study. Consideration of the addition of sirolimus to the GVHD prophylaxis regimen within the first 100 days after transplant must be reviewed with the study PI.\n* Prior history of allogeneic stem cell transplant other than SOC alloHSCT referred to in this study taking place 7 days prior to CIML NK infusion.\n* Prior history of solid organ (allograft) transplantation\n* Prior history of allergic reactions to cellular products\n* Uncontrolled concurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric\u002Fsocial illness that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by Flu\u002FCy chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n* HIV-positive patients are excluded due to the potential for interaction between antiretroviral therapy as well as the risk for lethal infection in the context of marrow-suppressive therapy.\n* Patients with active and uncontrolled Hepatitis B or C are ineligible due to the high risk of treatment-related hepatotoxicity after cellular therapy.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1. History of other malignancy and have had complete remission of disease for at least 2 years; 2. Diagnosed and treated within the past 2 years for: nonmetastatic melanoma, surgically resected (not needing systemic chemotherapy) squamous cell carcinoma of skin and nonmetastatic prostate cancer not needing systemic chemotherapy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study. 3. Diagnosed with MGUS or smoldering myeloma, and\u002For treated for multiple myeloma or plasmacytoma as long as attainment of complete remission by IMWG criteria following therapy.\n* Prior history of Grade 2 or higher hemolytic anemia (\\>\u002F= 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.\n\nInclusion Criteria to Receive CIML NK Infusion\n\n* Adequate organ function within 24 hours of NK cell infusion as defined below:\n\n  * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of ongoing hemolysis in opinion of investigator\n\nExclusion Criteria to Receive CIML NK Infusion:\n\n* Systemic steroid therapy (oral or IV) on the day of NK cell infusion\n* Uncontrolled concurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, or psychiatric\u002Fsocial illness that would limit compliance with study requirements.\n* Participants who have had other investigational agents within 4 weeks prior to CIML NK cell infusion (6 weeks for nitrosoureas or mitomycin C), or immunotherapy within 8 weeks prior, or those who have not recovered from adverse events due to agents administered more than 4 weeks prior. Therapy with BCR-ABL inhibitors must be stopped at least 2 weeks before CIML NK cell infusion and may not be resumed during the DLT period. The use of tocilizumab for cytokine release syndrome after stem cell infusion does not exclude patients, but the use of steroids for the treatment of CRS excludes patients if they are still on steroids by the day of planned NK cell infusion.\n* Systemic steroid use of \\>10mg\u002Fday of prednisone equivalent is an exclusion criteria unless there is a plan for dose to be tapered below this limit within 4 weeks prior to NK cell infusion.\n\nPatients must be off systemic steroid therapy on the day of planned NK cell infusion.\n\n-The presence of donor-specific antibodies (DSAs) with mean fluorescence intensity (MFI) \\>1000 using a standard assay who do not receive a desensitization protocol prior to and during stem cell transplant, or else who do receive a desensitization protocol and have detectable DSAs +1 day after stem cell infusion.\n\nIf inclusion\u002Fexclusion criteria are not met on planned day of CIML NK cell infusion, the NK cell infusion may be delayed for up to 48 hours to enable inclusion criteria to be met.\n\nHowever, patient may still receive CIML NK infusion if relevant parameters are reviewed and both PI and IND holder are in agreement with proceeding.",{"count":57,"type":21},15,[59],"PHASE1","The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant.\n\nNames of the study therapies involved in this study are:\n\n* CIML NK cells intravenous infusion (cellular therapy)\n* Subcutaneous Interleukin-2 (recombinant, human glycoprotein)",[62,63,29,64,65,66],"Acute Myeloid Leukemia","Leukemia","Myelodysplastic Syndromes","Myeloproliferative Neoplasm","Myeloproliferative Disorders",[62,63,29,68,69],"Myelodysplastic Syndrome","MDS and Myeloproliferative Neoplasm Overlap Syndrome","2026-06-15",{"date":72,"type":40},"2026-06-17",{"date":74,"type":40},"2024-01-24",{"date":76,"type":21},"2027-11-30",{"name":78,"class":47},"Dana-Farber Cancer Institute",2,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":111},"100516228","phase-1-safety-and-tolerability-of-ziftomenib-combinations-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100516228","NCT06001788","Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed\u002FRefractory Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Has been diagnosed with relapsed\u002Frefractory AML.\n* Has a documented NPM1 mutation or KMT2A rearrangement.\n* Has a documented FLT3 mutation (cA-3 only).\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.\n* Has adequate hepatic and renal function as defined per protocol.\n* Has an ejection fraction above a protocol defined limit.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.\n* Has agreed to use contraception as defined per protocol.\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.\n* Has clinically active central nervous system leukemia.\n* Has an active and uncontrolled infection.\n* Has a mean corrected QT interval (QTcF) \\> 480ms.\n* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \\\u003C14 days or within 5 drug half-lives prior to the first dose of study intervention.\n* Has had major surgery within 4 weeks prior to the first dose of study intervention.\n* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.\n* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD\n* Participant is pregnant or lactating.",{"count":88,"type":21},171,[59],"The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed\u002Frefractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.",[92,93,94,95,96,97,63,62,29,98,99,100],"AML","AML With Mutated NPM1","Hematologic Malignancy","KMT2Ar","NPM1 Mutation","MLL Rearrangement","Leukemia, Myeloid, Acute","Acute Leukemia","Neoplasms by Histologic Type","2026-04-10",{"date":103,"type":40},"2026-04-14",{"date":105,"type":40},"2024-02-22",{"date":107,"type":21},"2027-08",{"name":109,"class":110},"Kura Oncology, Inc.","INDUSTRY",45,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":131,"locationsCount":79},"100527826","phase-1-ciml-nk-cells-with-venetoclax-for-aml-100527826","NCT06152809","CIML NK Cells With Venetoclax for AML","A Phase 1 Study of Cytokine-induced Memory-like (CIML) NK Cells With Venetoclax as Consolidation Therapy in AML","Inclusion Criteria for Trial Enrollment (Screening Visit #1):\n\n* Diagnosis of acute myeloid leukemia (AML)\n* Age ≥ 18 years old\n* At time of screening patient is being treated with HMA(azacitidine or decitabine) + venetoclax therapy and has received at least 1 cycle of HMA (azacitidine or decitabine) + venetoclax. Patients can have received other lines of therapy prior to HMA + venetoclax therapy including prior chemotherapy and any prior stem cell transplant, provided that the stem cell transplant is \\> 6 months prior with no ongoing need for immunosuppressive therapy for active graft-versus-host disease.\n* Presence of molecular risk factors for relapse with continued HMA + venetoclax therapy as defined by any of the following present at the time of diagnosis or start of HMA + venetoclax therapy (these do not need to be present at the time the screening BM biopsy):\n\n  * 2022 ELN adverse risk karyotype: t(6;9)(p23.3;q34.1)\u002FDEK::NUP214; t(v;11q23.3)\u002FKMT2A-rearranged; t(9;22)(q34.1;q11.2)\u002FBCR::ABL1; t(8;16)(p11.2;p13.3)\u002FKAT6A::CREBBP; inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)\u002F GATA2, MECOM(EVI1), t(3q26.2;v)\u002FMECOM(EVI1)-rearranged; -5 or del(5q); -7; Complex karyotype, monosomal karyotype\n  * 2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and\u002For ZRSR2\n  * Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD\u002FTKD\n* ECOG performance status ≤2 (see Appendix A)\n* Participants must meet the following organ function as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n  * oxygen saturation ≥ 90% on room air\n  * left ventricular ejection fraction ≥ 40%\n* Negative pregnancy test for women of childbearing potential only.\n* The effects of CIML NK cells and IL-2 on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 4 months after the last IL-2 dose administration.\n* Participants with current symptoms of cardiac disease should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* Participants 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* Ability to understand and the willingness to sign a written informed consent document. (Providing consents in as many languages as possible is encouraged)\n* Subjects must be able to swallow pills.\n* No laboratory evidence of ongoing hemolysis in opinion of investigator (demonstration of hemolysis should include a haptoglobin level that is below assay).\n\nExclusion Criteria for Trial Enrollment (Screening visit #1)\n\n* Prior allogeneic stem cell transplant, organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy\n* Persisting Grade \\> 1 non hematologic toxicity related to prior therapy; however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.\n* Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease disease requiring any steroids \\>\\> the equivalent dose of 10 mg of prednisone or other immunosuppressive therapies at the time of this screening visit (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[e.g., Wegener's Granulomatosis\\]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis). Patients with Hashimoto's thyroiditis are eligible to go on study.\n* Pregnant women are excluded from this study because of the unknown teratogenic risk of CIML NK cells and IL-2 and with the potential for teratogenic or abortifacient effects by Flu\u002FCy chemotherapy regimen. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CIML NK cells and IL-2, breastfeeding should be discontinued if the mother is treated on this study.\n* HIV-positive participants are ineligible because of the potential for pharmacokinetic interactions with anti-retroviral agents used in this study. In addition, these participants are at increased risk of lethal infections when treated with marrow suppressive therapy.\n* Individuals with active uncontrolled hepatitis B or C are ineligible as they are at high risk of lethal treatment-related hepatotoxicity after conditioning therapy.\n* Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1. History of other malignancy and have had complete remission of disease for at least 2 years; 2. Diagnosed and treated within the past 2 years for: nonmetastatic melanoma, surgically resected (not needing systemic chemotherapy) squamous cell carcinoma of skin and nonmetastatic prostate cancer not needing systemic chemotherapy.\n* History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to IL-2 or other agents used in study.\n* Participants who are receiving any other investigational agents for this condition\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Prior history of Grade 2 or higher hemolytic anemia (≥ 2g decrease in hemoglobin plus laboratory evidence of hemolysis) from any cause.\n\nInclusion Criteria to Start Investigational Treatment Plan (Screening visit #2)\n\n* Patient was eligible for protocol per section 3.1.\n* Repeat bone marrow biopsy at this time shows a complete remission (CR) or complete remission with incomplete count recovery (CRi) or morphologic leukemia free state (MLFS) (\\\u003C 5% blasts) but with presence of measurable residual disease (MRD+). MRD can be determined by either flow cytometry, next generation sequencing or PCR. Patients with only persistent DNMTA, TET2 or ASXL1 mutations will not qualify as MRD+ as these DTA mutations without other comutations are associated with clonal hematopoiesis. OR\n* Repeat bone marrow biopsy at this time shows 5-19% residual myeloblasts in the bone marrow by either bone marrow aspirate or core biopsy.\n* Confirmed haploidentical or fully HLA-matched related donor that is willing and eligible for non-mobilized collection.\n* ECOG performance status ≤2 (see Appendix A)\n* Participants must meet the following laboratory and organ function as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n  * oxygen saturation ≥ 90% on room air\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* Negative pregnancy test for women of childbearing potential only.\n* Subjects must be able to swallow pills.\n\nExclusion Criteria to Start Investigational Treatment Plan (Screening visit #2)\n\n* No live vaccines within the last 6 months.\n* No ongoing or active infections.\n* Moderate\u002Fstrong inhibitors of CYP3A except of antifungal medications (such as posaconazole, voriconazole) which the patient is on and the dose of venetoclax has already been adjusted. These are excluded as moderate\u002Fstrong inhibitors of CYP3A induce higher drug levels of venetoclax which in turns carry the risk of CIML NK cell elimination.\n* The presence of donor-specific antibodies (DSAs) with mean fluorescence intensity (MFI) \\>1000 using a standard assay in subjects who do not receive a desensitization protocol prior to and during stem cell transplant.\n\nCriteria to Receive Lymphodepletion on Day -5\n\n* Adequate organ function within 24 hours of lymphodepletion as defined below:\n\n  * Direct bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST (SGOT)\u002FALT (SGPT): ≤ 3 x institutional ULN\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with lymphodepletion, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No live vaccines within the last 6 months\n\nCriteria to Receive CIML NK Infusion\n\n* Adequate organ function within 24 hours of NK cell infusion as defined below:\n\n  * Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * Creatinine clearance ≥ 45 mL\u002Fmin; calculated by the Cockcroft Gault formula\n* No Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with CIML NK infusion, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No systemic steroid therapy (oral or IV) of \\> 10mg prednisone or equivalent dose of other steroid agent on the day of NK cell infusion\n\nIf any of the above criteria are noted at these time points, please discuss with PI the benefits\u002Frisks of proceeding with the CIML infusion and document rationale for course of action taken in study regulatory binder. However, patient may still receive CIML NK infusion if relevant parameters are reviewed and both PI and IND holder agree with proceeding.\n\nIf inclusion\u002Fexclusion criteria are not met on planned day of CIML NK cell infusion, the NK cell infusion may be delayed for up to 24 hours to enable inclusion criteria to be met.\n\nCriteria to Receive Venetoclax\n\n* Adequate organ function within 24 hours of venetoclax initiation as defined below:\n\n  * Total bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then \\\u003C 3 x ULN)\n  * AST(SGOT)\u002FALT(SGPT): ≤3 x institutional ULN\n  * No Grade ≥3 non-hematologic toxicities of cyclophosphamide and fludarabine conditioning (except for Grade 3 nausea, vomiting, diarrhea, or constipation).\n* No significant change in clinical status that would, in the opinion of the investigator, increase the risk of adverse events associated with venetoclax administration, (e.g., significant hypoxemia, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, severe ongoing tumor lysis syndrome)\n* No evidence of active, uncontrolled infection. Patients receiving antibiotics for an infection may be treated if they have clinically responded to antibiotics. These cases should be reviewed with the study PI before proceeding.\n* No live vaccines within the last 6 months",{"count":5,"type":21},[59],"The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML).\n\nNames of the study therapies involved in this study are:\n\n* Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion\n* CIML NK (a cellular therapy)\n* IL-2 (a recombinant, human glycoprotein)\n* Venetoclax (a selective inhibitor of BCL-2 protein)",[62,123,63,29],"Acute Myeloid Leukemia Recurrent",[62,123,63,29],"2026-03-16",{"date":127,"type":40},"2026-03-18",{"date":129,"type":40},"2024-02-20",{"date":76,"type":21},{"name":78,"class":47},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":79},"100626713","phase-1-assessing-pi3k-gamma-inhibition-with-azacitidine-venetoclax-and-eganelisib-in-patients-with-acute-myeloid-leukemia-100626713","NCT07439211","Assessing PI3K Gamma Inhibition With Azacitidine, Venetoclax and Eganelisib in Patients With Acute Myeloid Leukemia","Safety of Targeting PI3Kgamma Signaling With Azacitidine, Venetoclax and Eganelisib in Acute Myeloid Leukemia: A Phase 1 Study (GAVEL)","GAVEL","Inclusion Criteria:\n\n* Subjects must have histologically confirmed AML that meets one of these categories of disease:\n\n  * Group A: Relapsed or Refractory: Subjects with relapsed or refractory AML or relapsed\u002Frefractory AML, who are not recommended for any approved targeted therapy must meet any one of the following criteria: (1) morphologic relapse (at least 5% blasts), or (2) refractory to intensive chemotherapy (at least one cycle of cytarabine and anthracycline-based intensive regimen) or at least 2 cycles of prior HMA\u002Fvenetoclax-based therapy (without CR\u002FCRh\u002FCRi). No limit to prior lines of AML therapy. OR\n  * (Expansion only) Group B: Untreated AML with ELN 2022 adverse risk disease: Subjects with newly diagnosed or previously untreated AML must be ineligible for intensive chemotherapy based on Ferrara criteria (age ≥75 years or presence of co- morbidity).\n* Evidence of marrow involved AML.\n* Age 18-90 years. Because no dosing or adverse event data are currently available on the use of eganelisib in participants \\\u003C18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.\n* Eastern Cooperative Oncology Group performance status ≤ 3 if 18 to 74 years of age or ECOG 0-2 if ≥ 75 years of age.\n* Subjects must meet the following organ and marrow function as defined below:\n\n  * total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or\n\n    ≤ 3 x ULN in case of Gilbert's disease\n  * AST(SGOT)\u002FALT(SGPT) ≤ 2.5 x × institutional ULN\n  * Creatinine clearance (CrCl) ≥ 30 L\u002Fmin (Cockcroft-Gault formula)\n* Prior history of CNS leukemia that has been treated, asymptomatic and controlled are eligible. CNS evaluation is not required for screening if asymptomatic.\n* Subjects with a prior or concurrent malignancy (other than MDS, MPN, MDS\u002FMPN, or AML) 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. Treatment must be at least 12 months from last dose of chemotherapy or immunotherapy (except no window is required for palliative radiation or supportive or hormonal therapies). Concurrent malignancy must be considered not active or requiring therapy.\n* Male subjects and female subjects\u002Fwomen of childbearing potential (WCBP) must agree to the following: The effects of eganelisib on the developing human fetus are unknown. For this reason and because other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. When eganelisib is being used alone, the duration of contraception after the last dose should be 3 months for both males and females of childbearing potential. When eganelisib is being used with azacitidine + venetoclax, according to the USPI for azacitidine, females of reproductive potential should use effective contraception during treatment with azacitidine and for 6 months after the last dose and males with female partners of reproductive potential should use effective contraception during treatment with azacitidine and for 3 months after the last dose. WCBP must have negative serum beta human chorionic gonadotropin test measured within 7 days prior to the first dose of eganelisib and consent to ongoing pregnancy testing during the study.\n* Willingness to practice adequate sun protection (i.e. use of sunscreen or sun-protective clothing, limitation of sun and artificial ultraviolet \\[UV\\] exposure) for the study duration and for 30 days after the last dose of eganelisib.\n* Agree to the protocol-required bone marrow biopsies.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior systemic cancer therapy is allowed as long as \\>14 days prior to study treatment start. Hormonal therapy may be allowed if approved by Sponsor-Investigator.\n* Major surgery within 28 days prior to study treatment start.\n* Allogeneic stem cell transplant within 100 days prior to study treatment start.\n* Active graft-versus-host disease (GVHD) after allogeneic stem cell transplantation or chronic GVHD requiring systemic steroid administration. Topical therapies are allowed for controlled GVHD.\n* Receiving systemic immunosuppressive therapy such as steroids or calcineurin inhibitors.\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy with the exception of alopecia.\n* Participants who are receiving any other investigational AML directed-agents for this condition.\n* White blood cell count \\> 25x109\u002FL prior to first dose of study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to eganelisib, venetoclax, or azacitidine.\n* Participants receiving any medications or substances within 14 days prior to first dose of study drug and for duration of the study:\n\n  * Moderate or strong inhibitors or inducers of CYP2C8 and CYP3A4, including grapefruit, grapefruit juice, Seville oranges, St. John's wort and herbal supplements, except for antibiotics, antifungals, or antivirals that are moderate or strong inhibitors of CYP3A (preference for moderate CYP3A inhibitors if antifungal therapy is recommended when clinically acceptable).\n  * P-glycoprotein (P-gp) inhibitors except for azole antifungals.\n  * Breast cancer resistance protein (BCRP) inhibitors.\n* Administration of any of the following as of Cycle 1 Day 1 and for the study duration: Substrates with a narrow therapeutic index for P-gp, or Warfarin, phenytoin, or other substrates with a narrow therapeutic index for CYP2C8 or CYP2C9\n* Pregnant women are excluded from this study because eganelisib is an agent without known fertility and developmental toxicity studies. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with eganelisib, breastfeeding should be discontinued if the mother is treated with eganelisib. These potential risks may also apply to other agents used in this study.\n* History or current evidence of any acute or chronic condition, therapy, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or might confound the results of the trial, interfere with participation for the full duration of the trial, or render trial participation not compatible with the participant's best interest, in the opinion of the Investigator.\n* Participant must be able to swallow pills and not have any known gastrointestinal abnormality that would affect drug absorption (examples include gastric bypass, gastrectomy, chronic diarrhea).","90 Years",{"count":142,"type":21},48,[59],"This study is to evaluate the safety and preliminary efficacy of adding the PI3K-gamma inhibitor, eganelisib, to a standard of care treatment option with combination venetoclax and azacitidine in participants with acute myeloid leukemia (AML).\n\nThe names of the study drugs involved in this research study are:\n\n* Venetoclax (a type of BCL-2 inhibitor)\n* Azacitidine (a type of Demethylating Agent)\n* Eganelisib (a type of PI3K-gamma inhibitor)",[29,63,62,146],"Refractory Leukemia",[29,63,62,148,149,92],"Refractory Acute Myeloid Leukemia","Relapsed Acute Myeloid Leukemia","NOT_YET_RECRUITING","2026-02-28",{"date":153,"type":40},"2026-03-03",{"date":155,"type":21},"2026-07",{"date":157,"type":21},"2029-02-01",{"name":159,"class":47},"Jacqueline Garcia, MD",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100554600","phase-1-a-study-of-bh-30236-in-relapsed-refractory-acute-myelogenous-leukemia-and-higher-risk-myelodysplastic-syndrome-100554600","NCT06501196","A Study of BH-30236 in Relapsed\u002F Refractory Acute Myelogenous Leukemia and Higher Risk Myelodysplastic Syndrome","A Phase 1\u002F1b Open-Label, Dose Escalation, First-in- Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-leukemic Activity of the Orally Available CDC-Like Kinase (CLK) Inhibitor, BH-30236, in Adults With Relapsed or Refractory Acute Myelogenous Leukemia (R\u002FR AML) or Higher-Risk Myelodysplastic Syndrome (HR-MDS)","Inclusion criteria:\n\n* ≥18 years.\n* Diagnosis of relapsed\u002Frefractory acute myelogenous leukemia (R\u002FR) AML or higher-risk myelodysplastic syndrome (HR-MDS) with ≥5% bone marrow blast at time of inclusion.\n* Prior treatment history must include 1-5 prior lines of therapy.\n* ECOG performance status ≤2.\n* Adequate organ function evidenced by the following laboratory values:\n* Hepatic: Transaminase levels aspartate aminotransferase \\[AST\\]\u002F alanine transaminase \\[ALT\\] ≤ 2.5 × upper limit of normal (ULN). In cases of liver involvement by AML or MDS, AST and ALT \\\u003C 5.0 × ULN is acceptable. Total bilirubin ≤ 1.5 × ULN in the absence of documented Gilbert's disease.\n* Renal: Measured or calculated creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault formula)\n\nThe above are a summary, other inclusion criteria details may apply.\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia with blast crisis.\n* Prior allogeneic HSCT within 3 months or donor lymphocyte infusion within 30 days of start of therapy;\n* Active and uncontrolled infections.\n* Unresolved AEs greater than Grade from prior therapies.\n* History of other active malignancy (with certain exceptions)\n* Prior treatment with a CLK inhibitor.\n* Any acute or chronic graft versus host disease requiring systemic therapy within 4 weeks prior to study drug administration with the exception of topical steroids or the equivalent of 20 mg of prednisone or less.\n\nThe above is a summary, other exclusion criteria details may apply.",{"count":168,"type":21},170,[59],"Study BH-30236-01 is a first-in-human (FIH), Phase 1\u002F1b, open-label, dose escalation and expansion study in participants with relapsed\u002Frefractory acute myelogenous leukemia (R\u002FR AML) or higher-risk myelodysplastic syndrome (HR-MDS).\n\nPhase 1, Part 1 Dose Escalation - Monotherapy will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered orally. Approximately 50 participants may be enrolled in Phase 1, Part 1 Dose Escalation - Monotherapy.\n\nPhase 1, Part 2 Dose Escalation - Combination with Venetoclax will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of BH-30236 administered as a combination therapy with venetoclax. Approximately 48 participants may be enrolled in Phase 1, Part 2 Dose Escalation - Combination with Venetoclax.\n\nPhase 1b (Dose Expansion) will follow Phase 1 to further understand the relationships among dose, exposure, toxicity, tolerability, and clinical activity. Up to 72 participants may be enrolled in Phase 1b of the study as a monotherapy or in combination with venetoclax.",[63,29,98,172,64,148],"Preleukemia","2025-09-19",{"date":175,"type":40},"2025-09-24",{"date":177,"type":40},"2024-06-19",{"date":179,"type":21},"2027-06",{"name":181,"class":110},"BlossomHill Therapeutics",13,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":22,"phases":193,"briefSummary":194,"conditions":195,"keywords":211,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":231},"100501157","phase-2-allo-hsct-using-ric-and-ptcy-for-hematological-diseases-100501157","NCT05805605","Allo HSCT Using RIC and PTCy for Hematological Diseases","Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\\u003C 16 years).\n* 5\u002F6 or 6\u002F6 related donor, OR a 7-8\u002F8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5\u002F10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.\n\nEligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.\n\nAcute Myeloid Leukemia (AML) and related precursor neoplasms:\n\n2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n\nFavorable risk AML is defined as having one of the following:\n\n* t(8,21) without cKIT mutation\n* inv(16) or t(16;16) without cKIT mutation\n* Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)\n* Normal karyotype with double mutated CEBPA\n* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n\nAcute lymphoblastic Leukemia (ALL) \u002Flymphoma:\n\nCR2 or greater, CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n\nHigh risk ALL is defined as having one of the following:\n\n* Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n* 30 years of age or older at diagnosis\n* White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n* CNS leukemia involvement during the course of disease\n* Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.\n\nVery high risk pediatric patients with ALL:\n\npatients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n\nBiphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n\nChronic Myelogenous Leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (\\\u003C5% blasts) and with negative MRD by flow cytometry (a positive PCR for BCRABL is acceptable for BMT): Chronic phase patients must have failed at least two different TKIs, been intolerant to all available TKIs or have T315I mutation. Patients with CML blast crisis in CR are only eligible if there is an feasible TKI maintenance plan following BMT.\n\nPlasma Cell Leukemia after initial therapy, who achieved at least a partial remission; or relapsed and achieved subsequent remission (CR\u002FPR) Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\\u003C 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\\u003C 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to \\\u003C5% blasts prior to transplantation Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.\n\nBurkitt's Lymphoma in CR2 or subsequent CR. Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR\u002FPR that has failed or ineligible for an autologous transplantNatural Killer Cell Malignancies. Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for de-bulking chemotherapy before transplant. Patients with refractory disease may be eligible, unless bulky disease and an estimated tumor doubling time of less than one month.\n\nLymphoplasmacytic Lymphoma, Mantle-Cell Lymphomais eligible after initial therapy if chemotherapy sensitive.\n\nLarge Cell and other high risk NHL \\> CR2\u002F\\> PR2: Patients in CR2\u002FPR2 with initial short remission (\\\u003C6 months) are eligible.\n\nRelapsed Multiple Myeloma: that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.\n\nMyeloproliferative Neoplasms\u002FMyelofibrosis - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.\n\nAcquired Bone Marrow Failure Syndromes except for Fanconi anemia Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nAdditional Criteria for Bulky Disease (lymphomas) if stable disease is best response, the largest residual nodal mass must \\\u003C 5 cm (approximately) If response to previous therapy, the largest residual mass must represent a 50% reduction and be \\\u003C 7.5 cm (approximately)\n\nOrgan Function Criteria\n\nAdequate organ function is defined as:\n\nLiver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis.\n\nRenal: A normal creatinine (adults) or creatinine clearance ≥ 40 mL\u002Fmin (pediatrics). Adults with a creatinine \\> 1.2 mg\u002Fdl or a history of renal dysfunction must have estimated GFR ≥ 40 ml\u002Fmin\u002F1.73m2.\n\nCardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.\n\nPulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n\nIf recent confirmed mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Sexually active females of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control during study treatment Voluntary written consent (adult or parent\u002Fguardian with presentation of the minor information sheet, if appropriate)\n\nRelated donors will be evaluated and collected according to UMN BMT program standard processes. Unrelated donors will be identified and collected through the National Marrow and Donor Program (NMDP) per usual steps.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.\n* Untreated active infection\n* Active central nervous system malignancy\n* CML in blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Less than 3 months since prior myeloablative transplant\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.","75 Years",{"count":192,"type":21},56,[24],"This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide\u002F fludarabine\u002Ftotal body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.",[196,197,198,199,200,201,202,64,29,203,204,205,206,207,208,209,65,210],"Acute Myelogenous Leukemia","Acute Lymphocytic Leukemia","Biphenotypic Acute Leukemia","Undifferentiated Leukemia","Prolymphocytic Leukemia","Chronic Myelogenous Leukemia","Plasma Cell Leukemia","Myelodysplastic Syndrome With Excess Blasts-1","Burkitt Lymphoma","Relapsed T-Cell Lymphoma","Relapsed Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone Lymphoma","Follicular Lymphoma","Myelofibrosis",[212,213,214,92,215,216,217,218,219,220,221,17],"MDS","CLL","SLL","CML","PFS","TRM","GVHD","MMF","TBI","PTCy","2025-06-27",{"date":224,"type":40},"2025-07-01",{"date":226,"type":40},"2023-05-01",{"date":228,"type":21},"2028-10-22",{"name":230,"class":47},"Masonic Cancer Center, University of Minnesota",1,{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":243,"conditions":244,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":231},"100557408","breath-analysis-for-the-detection-of-invasive-fungal-infections-100557408","NCT06537726","Breath Analysis for the Detection of Invasive Fungal Infections","Real-time Breath Analysis for the Detection of Invasive Fungal Infections in Neutropenic High-risk Patients","REDEFINE","Inclusion Criteria:\n\n* Diagnosis of acute leukemia\n* Planned chemotherapy with a duration of hospitalisation of 2 weeks or longer\n* Neutropenia (\\\u003C500\u002Fµl) present at inclusion or planned chemotherapy with expected neutropenia (\\\u003C500\u002Fµl) for more than 7 days\n\nExclusion Criteria:\n\n* Unable to follow instructions for breath analysis\n* Anatomic abnormalities precluding the use of a mouthpiece for breath analysis",{"count":241,"type":21},130,"OBSERVATIONAL","Patients with leukemia and concomitant neutropenia are at high risk of developing invasive fungal infections (IFI) that are associated with high morbidity and mortality. As these patients typically have severe thrombocytopenia, direct diagnostic sampling with invasive procedures is often not possible due to the high peri-interventional risk. Therefore, the presumptive diagnosis of IFI is primarily based on compatible lung findings on computed tomography and serologic detection of fungal cell wall components, which, however, have limited sensitivity and specificity.\n\nWith the present study, the investigators aim to determine a set of specific volatile biomarkers in leukemia patients with proven or probable IFI using secondary electrospray ionization high-resolution mass spectrometry (SESI-HRMS).",[63,29,245,246,247,248,249],"Leukemia, Lymphoblastic","Neutropenia","Chemotherapy-induced Neutropenia","Invasive Fungal Infections","Invasive Pulmonary Aspergillosis","2025-04-09",{"date":252,"type":40},"2025-04-10",{"date":254,"type":40},"2024-08-19",{"date":256,"type":21},"2027-10-31",{"name":258,"class":47},"University of Zurich",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":271,"conditions":272,"keywords":273,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":285,"locationsCount":231},"100565575","venetoclax-combined-with-intensive-therapy-for-acute-myeloid-leukemia-patients-with-lower-early-peripheral-blast-clearance-rate-after-standard-induction-therapy-100565575","NCT06643962","Venetoclax Combined with Intensive Therapy for Acute Myeloid Leukemia Patients with Lower Early Peripheral Blast Clearance Rate After Standard Induction Therapy","A Single-Center Prospective Cohort Study to Evaluate the Efficacy and Safety of Intensifying Treatment with Venetoclax in Patients with Newly Diagnosed Acute Myeloid Leukemia (non-APL) and Exhibiting Lower Early Peripheral Blast Clearance Rate After Standard Intensive Induction Chemotherapy","Inclusion Criteria:\n\n* Newly diagnosed AML, except for the APL subtype, according to the 2022 World Health Organization classification (WHO 2022 criteria)\n* Age ≥18 years and ≤70 years\n* Eligible for intensive chemotherapy\n* No prior chemotherapy for AML except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \\[WBC\\] counts\\>25x10\\^9\u002FL)\n* Eastern Cooperative Oncology Group (ECOG) performance status≤2\n* Adequate renal function is defined as:\n\n  * Serum creatinine≤2.0×upper limit of normal (ULN)\n  * Creatinine clearance (CrCl)\\>30 mL\u002Fmin calculated by the Cockcroft-Gault equation.\n* Adequate hepatic and heart function is defined as:\n\n  * Serum total bilirubin≤1.5×ULN unless considered due to Gilbert's disease, or leukemic involvement\n  * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP)≤2.5×ULN, unless considered due to leukemic involvement\n  * Myocardial enzyme\\\u003C2.0×ULN\n  * Left ventricular ejection fraction is within the normal range by measure of echocardiogram (ECHO)\n* Signed a written informed consent form (ICF)\n* Female participants who are of non-reproductive potential (i.e., post-menopausal by history of no menses for ≥1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy). Female participants of childbearing potential must have a negative serum pregnancy test upon study entry\n\nExclusion Criteria:\n\n* AML with BCR-ABL1 or myeloid blast crisis of CML\n* Participants who have received prior treatment for AML with chemotherapy, hypomethylating agents, or venetoclax\n* Participants who are ineligible for intensive induction chemotherapy:\n\n  * ≧71 years old OR\n  * ≧18 to 70 years old and fulfill at least one criterion associated with lack of fitness for intensive induction chemotherapy:\n\n    * ECOG PS of 2-3\n    * Cardiac history of CHF requiring treatment or Ejection Fraction ≦50% or chronic stable angina\n    * Diffusing capacity of the lungs for carbon monoxide (DLCO)≦65% or the forced expiratory volume in one second (FEVI) ≦65%\n* Participants with a prior history of MDS, MPN, or MDS\u002FMPN\n* Participants with other concurrent malignant tumors on treatment, except for:\n\n  * Malignancy treated with curative intent and with no known active disease present for ≧3 years\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without current evidence of disease\n  * Adequately treated carcinoma in situ without current evidence of disease\n  * Localized prostate cancer with a Gleason score of 6 or less\n* Pregnant or lactating women\n* Active heart disease is defined as any one of the following:\n\n  * Uncontrolled or symptomatic angina pectoris\n  * A myocardial infarction six months before enrolled\n  * Arrhythmia needs medication or with severe clinical symptoms\n  * Uncontrolled or symptomatic congestive heart failure (New York Hear Association \\[NYHA\\] classification\\> grade 2)\n* Participants with an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment\n* Participants with an active viral infection caused by HIV, hepatitis B, or hepatitis C virus that cannot be controlled by treatment\n* Participants with evidence of central nervous system leukemia before the study treatment\n* Participants with epilepsy which needs drug treatment, dementia, or other abnormal mental states that prevent understanding or following the protocol\n* Conditions that restrict the intake or absorption of orally administered drugs","70 Years",{"count":268,"type":21},83,[270],"NA","This single-center prospective cohort study aims to evaluate the efficacy and safety of Intensifying treatment with Venetoclax along with intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) except acute promyelocytic leukemia (non-APL) and exhibiting lower early peripheral blast clearance rate (EPBCR) after standard Intensive Induction therapy (3+7 regimen).",[63,29,98],[274,275,276,277,278],"acute myeloid leukemia","venetoclax","intensive chemotherapy","early peripheral blast clearance","newly diagnosed","2024-11-10",{"date":281,"type":40},"2024-11-12",{"date":283,"type":40},"2024-10-31",{"date":256,"type":21},{"name":286,"class":47},"Affiliated Hospital of Nantong University",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":242,"phases":4,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":231},"100555478","eln-2022-in-menafc--middle-eastern-or-north-coast-of-africa--patients-with-newly-aml-100555478","NCT06512610","ELN 2022 in MENAFC ( Middle Eastern or North Coast of Africa ) Patients With Newly AML","Validation of the Use of the \"ELN 2022\" Risk Stratification System in HLA MENAFC Patients Newly Diagnosed With Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Newly diagnosed AML\n* At least 18 yo\n* MENAFC (Middle East ern of North Coast of Africa) patients with HLA HLA \\> 50%\n* ECOG performance status of 0,1,2,3\"\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia\n* Patients alive at the start of the study who did not receive study information or who objected to the collection of data\"","80 Years",{"count":20,"type":21},"\"In daily clinical practice, 2022 ELN guidelines were used to predict response to conventional treatment and to guide the need for allogenic stem cell transplantation. But, the team has to underline that ELN guidelines are mainly reflective of relatively young Caucasian patients. Few studies have compared 2017 and 2022 ELN in ethnicity cohorts to evaluate the potential prognostic value of this new criteria in these types of population. For example, with the 2022 ELN guidelines, the disease-free surviva) and the overall survival of African American \\\u003C 60 y.o were not statistically different between intermediate and adverse groups (p=0.30, p=0,46). There were not a significant difference between favorable and intermediate groups in DFS (p=0.42, p=0.42) respectively in African American and Hispanic patients or in OS (p=0.67) in Hispanic patients. Is the 2022 ELN applicable to all ethnic subgroups? To date, no studies have examined and validated its applicability in Middle Eastern or North Coast of Africa (MENAFC) patients.\"",[29],"2024-07-16",{"date":300,"type":40},"2024-07-22",{"date":302,"type":21},"2024-08-01",{"date":304,"type":21},"2025-01-01",{"name":306,"class":47},"Centre Hospitalier Universitaire de Nice"]