[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aml":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,54,0,25,[9,47,78,104,125,149,168,195,234,262,288,313,385,425,444,468,488,511,531,558,590,613,632,652,678],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100580206","phase-1-cer-1236-in-patients-with-acute-myeloid-leukemia-aml-myelodysplastic-syndrome-mds-and-myelofibrosis-mf-100580206",false,"NCT06834282","CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)","Phase 1\u002F1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelofibrosis (CertainT-1)","CertainT-1","Inclusion Criteria:\n\n* Patients need to have a confirmed diagnosis of de novo or secondary AML, or myelodysplastic syndrome (MDS)\u002FAML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.\n* Absolute lymphocyte count \\>0.3 x 109\u002FL prior to apheresis.\n* Eastern cooperative oncology group (ECOG) performance status 0 to 1.\n\nExclusion Criteria:\n\n* Prior therapy with a permanently integrated, genetically modified cell product.\n* No measurable leukemia on the screening bone marrow evaluation prior to any bridging therapy.\n* Active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years. Patients with history of autoimmune thyroiditis or type 1 diabetes well controlled on replacement regimen are eligible.\n* A known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents.\n* Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician.\n* Primary immunodeficiency disorder.","ALL","18 Years","85 Years",{"count":22,"type":23},18,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a ﬁrst in human, multi center, open label, phase 1\u002F1b study to evaluate the safety and preliminary efﬁcacy of CER-1236 in patients with relapsed\u002Frefractory (R\u002FR), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.",[29,30,31],"AML","Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia",[33],"Relapsed Acute Myeloid Leukemia","RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":38},"2025-04-07",{"date":42,"type":23},"2029-12-31",{"name":44,"class":45},"CERo Therapeutics Holdings, Inc.","INDUSTRY",4,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":24,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"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":55,"type":23},171,[26],"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.",[29,59,60,61,62,63,64,30,65,66,67,68],"AML With Mutated NPM1","Hematologic Malignancy","KMT2Ar","NPM1 Mutation","MLL Rearrangement","Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Acute Leukemia","Neoplasms by Histologic Type","2026-08-19",{"date":35,"type":38},{"date":72,"type":38},"2024-02-22",{"date":74,"type":23},"2027-08",{"name":76,"class":45},"Kura Oncology, Inc.",45,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":24,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100630639","venetoclax-azacitidine-and-liposomal-mitoxantrone-for-newly-diagnosed-aml-100630639","NCT07490288","Venetoclax, Azacitidine and Liposomal Mitoxantrone for Newly Diagnosed AML","A Single-Arm, Open-Label Study of Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) as Induction Therapy in Newly-diagnosed Adult Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Patients diagnosed with AML according to the WHO (2022) or ICC criteria, or with MDS\u002FAML as defined by ICC (with 10%-20% blasts in the bone marrow)\n* Age ≥ 14 years, male or female.\n* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n* Meet the following laboratory requirements (tests must be performed within 7 days prior to treatment):\n\n  i. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) for the corresponding age group.\n\nii. AST and ALT ≤ 2.5 times ULN for the corresponding age group. iii. Serum creatinine \\\u003C 1.5 times ULN for the corresponding age group. iv. Cardiac enzymes \\\u003C 2 times ULN for the corresponding age group. v. Left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiography (ECHO).\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML::RARA fusion gene.\n* Acute myeloid leukemia with RUNX1::RUNX1T1 fusion gene.\n* Acute myeloid leukemia with BCR::ABL1 fusion gene.\n* Previously treated patients (defined as having received prior induction chemotherapy for AML\u002FMDS; prior use of cytoreductive agents like hydroxyurea is allowed).\n* Concurrent active malignancy of other organs (requiring treatment).\n* Active cardiac disease, defined as one or more of the following:\n\n  i. History of uncontrolled or symptomatic angina. ii. Myocardial infarction within 6 months prior to study enrollment. iii. History of clinically significant arrhythmia requiring medication or causing severe symptoms.\n\niv. Uncontrolled or symptomatic congestive heart failure (\\> New York Heart Association \\[NYHA\\] Class 2).\n\n* Active, uncontrolled infectious diseases (e.g., untreated tuberculosis, pulmonary aspergillosis).\n* Any other condition that, in the opinion of the investigator, makes the patient unsuitable for study participation.","14 Years","100 Years",{"count":88,"type":23},27,[90],"NA","This is a single-arm, open-label clinical trial evaluating the safety and preliminary efficacy of a novel induction regimen combining Venetoclax, Azacitidine, and Liposomal Mitoxantrone (VAM) in patients with newly diagnosed Acute Myeloid Leukemia (AML) who are eligible for intensive chemotherapy.\n\nThe study plans to enroll 27 participants. Patients will receive VAM induction therapy, followed by three cycles of intermediate-dose cytarabine consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for high-risk or MRD-positive patients in remission.",[29],"2026-08-05",{"date":95,"type":38},"2026-08-07",{"date":97,"type":38},"2026-05-08",{"date":99,"type":23},"2029-03-01",{"name":101,"class":102},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":24,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":103},"100573301","phase-3-standard-dose-vs-intermediate-dose-cytarabine-induction-in-the-treatment-of-acute-myeloid-leukemia-with-runx1-runx1t1-100573301","NCT06744504","Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1","Anthracycline-based Standard-dose vs Intermediate-dose Cytarabine Induction in the Treatment of Acute Myeloid Leukemia With RUNX1-RUNX1T1: a Prospective, Randomized, Controlled Phase III Clinical Trial","Inclusion Criteria:\n\n1. AML conforming to WHO (2022) or ICC standards\n2. Possessing the RUNX1::RUNX1T1 fusion gene\n3. Age ranging from 14 to 60 years old, regardless of gender.\n4. The performance status assessment of the Eastern Cooperative Oncology Group (ECOG-PS) being 0 - 2.\n5. Meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment):\n\n1\\) Total bilirubin ≤ 1.5 times the upper limit of the normal value for the same age group; 2) AST and ALT ≤ 2.5 times the upper limit of the normal value for the same age group; 3) Serum creatinine \\\u003C 2 times the upper limit of the normal value for the same age group; 4) Cardiac enzymes \\\u003C 2 times the upper limit of the normal value for the same age group; 5) The cardiac ejection fraction determined by echocardiography (ECHO) \\> 50%. An informed consent form must be signed before the commencement of all specific research procedures, either by the patient themselves or their immediate relatives. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent form shall be signed by the legal guardian or the immediate relatives of the patient.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia accompanied by PML-RARA fusion gene.\n2. Acute myeloid leukemia featuring BCR-ABL fusion gene.\n3. Patients undergoing retreatment (but can receive cytoreductive therapy with hydroxyurea and cytarabine).\n4. Individuals concurrently having malignant tumors in other organs (requiring treatment).\n5. Active cardiac disorders, defined as one or more of the following:\n\n1\\) A history of uncontrolled or symptomatic angina pectoris; 2) Myocardial infarction less than 6 months from study enrollment; 3) A history of significant arrhythmia requiring medication or presenting with severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\\> NYHA Class 2)\n\n6\\. Severe infectious diseases (untreated tuberculosis, pulmonary aspergillosis).\n\n7\\. Individuals deemed ineligible for enrollment by the investigator.","60 Years",{"count":113,"type":23},284,[115],"PHASE3","Leukemia is one of the common malignant tumors that threaten human health. Although the efficacy of AML treatment has improved significantly in recent years, it remains one of the major diseases threatening human health. Current research on AML treatment mainly has two directions. One is the addition of new targeted therapy drugs, and the other research direction is to enhance the intensity of AML chemotherapy, including the use of large doses of anthracycline drugs or the use of high-dose cytarabine treatment.\n\nSince the 1990s, induction remission has been achieved by using anthracyclines in combination with high-dose cytarabine. The ECOG (Eastern Cooperative Oncology Group) contends that high-dose induction chemotherapy fails to enhance the bone marrow remission rate but elevates the chemotherapy-related mortality rate. Bradstock and the Australian Group also noted that although it does not increase the bone marrow remission rate, it can result in longer survival time and disease-free survival time. The clinical study from EORTC-GIMEMA AML-12 discovered that AML patients under the age of 45 could benefit from induction therapy incorporating high-dose cytarabine. In our previous randomized controlled clinical trials, it was found that the HAD and DA regimens containing intermediate-dose cytarabine could enhance the complete remission rate and improve the overall survival of adult AML. However, the degree of benefit varies among different AML subgroups.\n\nThe abnormalities of RUNX1-RUNX1T1 and CBFβ-MYH11 respectively involve a subunit of CBF (core binding factor), thus the two are collectively called CBF leukemia. Previous retrospective studies show that this type of leukemia benefits from intensified treatment regimens such as FLAG. However, at present, there is a lack of prospective randomized controlled clinical studies to confirm this. Therefore, in this study, we intend to further verify through a prospective randomized controlled clinical trial whether the induction treatment regimen containing intermediate-dose cytarabine can improve the long-term efficacy of adult RUNX1-RUNX1T1 acute myeloid leukemia.",[29,118],"RUNX1-RUNX1T1 Fusion Protein Expression",{"date":95,"type":38},{"date":121,"type":38},"2025-01-10",{"date":123,"type":23},"2029-12-01",{"name":101,"class":102},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":24,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":103},"100556756","intermediate-dose-had-regimen-for-cebpa-double-mutated-aml-100556756","NCT06529250","Intermediate-dose HAD Regimen for CEBPA Double-mutated AML","A Multicenter, Randomized, Controlled Clinical Trial of Intermediate-dose HAD Regimen for CEBPA Double-mutated Acute Myeloid Leukemia","HADCEBPA2023","Inclusion Criteria:\n\n1. AML diagnosed according to WHO-2022 classification with recurrent CEBPA mutations and containing mutation in the bZIP domain.\n2. Older than 14 years old and younger than 55 years old\n3. Male or female.\n4. The Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of AML patients were 0-2 points.\n5. Meet the following laboratory tests (performed within 7 days prior to treatment) 1) Total bilirubin ≤ 1.5 times of the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times of the upper limit of normal value (same age); 3) Blood creatinine \\\u003C 2 times of the upper limit of normal value (same age); 4) Myocardial enzymes \\\u003C 2 times of the upper limit of normal value (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range.\n\nExclusion Criteria:\n\n1. Patients who have previously received induction chemotherapy, regardless of efficacy.\n2. Simultaneously suffering from malignant tumors of other organs and requiring treatment).\n3. Pregnant or lactating women. Male or female patients participating in the trial must take contraceptive measures during the trial treatment period.\n4. Active heart disease, defined as one or more of the following:1) Have a history of uncontrolled or symptomatic angina pectoris;2) Myocardial infarction less than 6 months prior to enrollment in the study;3) A history of arrhythmia requiring medication treatment or severe clinical symptoms;4) Uncontrolled or symptomatic congestive heart failure (\\> NYHA grade 2);5) The ejection fraction is below the lower limit of the normal range.\n5. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).\n6. Those who were not considered suitable for inclusion by the researchers.","54 Years",{"count":135,"type":23},148,[90],"AML is highly heterogeneous in pathogenesis, and CEBPA double-mutated (CEBPAdm) AML is a common type of leukemia in China. Currently, no targeted therapies for CEBPAdm, and chemotherapy and transplantation are still the treatment options for CEBPA double-mutated AML. At present, the \"3+7\" treatment induction regimen of cytarabine combined with anthracyclines is still the first-line recommended regimen. In our retrospective study, the intermediate dose HAD regimen produced a 3-year RFS of 84.7% and a 3-year OS of 92.8% in CEBPAdm AML. Therefore, this project intends to confirm the efficacy of intermediate-dose HAD in the treatment of CEBPA double-mutated AML is superior to the conventional treatment regimen through the multi-center RCT study.",[29],[29,140,141],"CEBPA double-mutated","treatment",{"date":143,"type":38},"2026-08-10",{"date":145,"type":38},"2024-08-13",{"date":147,"type":23},"2029-09-01",{"name":101,"class":102},{"id":150,"slug":151,"hasResults":12,"nctId":152,"briefTitle":153,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":24,"phases":157,"briefSummary":158,"conditions":159,"keywords":162,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":163,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":103},"100536493","multicenter-platform-type-clinical-study-of-refractoryrecurrent-acute-myeloid-leukemia-100536493","NCT06265545","Multicenter, Platform-type Clinical Study of Refractory\u002FRecurrent Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1\\. Patients with acute myeloid leukemia (except for acute promyelocytic leukemia) diagnosed by bone marrow cell morphology, immunology and genetics above are classified according to the French-British-American Collaboration diagnostic criteria (FAB criteria) and the World Health Organization diagnostic criteria (WHO2016 criteria).\n\n  2\\. Meet criteria for refractory\u002Frecurrent AML (except APL). The recurrence was morphological recurrence, excluding molecular recurrence. Except for simple extramedullary leukemia.\n\n  3\\. Age and gender are not limited. 4. Informed consent must be signed before the start of the study procedure, and the informed consent must be signed by the patient himself or his immediate family if he is 18 years old and above; For young patients under the age of 18, the legal guardian shall sign the informed consent. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family.\n\nExclusion Criteria:\n\n1. Concurrent malignant tumors of other organs (patients requiring treatment).\n2. Participants considered unsuitable for inclusion by the researchers.",{"count":156,"type":23},458,[90],"To study the optimal therapeutic strategies for salvage treatment of refractory\u002Frelapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R\u002FR AML with different treatment regimens.",[29,160,161],"Refractory","Relapsed",[29,160,161],{"date":95,"type":38},{"date":72,"type":38},{"date":166,"type":23},"2028-06-30",{"name":101,"class":102},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":176,"enrollmentInfo":177,"targetDuration":4,"studyType":24,"phases":179,"briefSummary":181,"conditions":182,"keywords":184,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":103},"100650460","phase-2-hma-venetoclax-induction-in-newly-diagnosed-aml-100650460","NCT07748455","HMA-Venetoclax Induction in Newly Diagnosed AML","HMA-Venetoclax Induction in Young, Fit Patients With Newly Diagnosed Acute Myeloid Leukaemia: A Prospective, Single-Arm, Phase II Study","VENTURE-AML","Inclusion Criteria\n\nPatients must satisfy ALL of the following criteria to be eligible for enrolment:\n\n1. Age 18-50 years (inclusive) at the time of enrolment\n2. Confirmed diagnosis of AML (non-APL) per WHO 2022 Classification: ≥20% blasts in bone marrow or peripheral blood, or documented leukaemia-defining cytogenetic abnormality regardless of blast count (e.g. t(8;21), inv(16), t(15;17) is excluded as APL). Diagnosis must be confirmed by bone marrow aspirate and\u002For biopsy with morphology, flow cytometry, and cytogenetics.\n3. Newly diagnosed AML: no prior cytotoxic therapy for AML (excluding hydroxyurea for blast cytoreduction, which is permitted for ≤7 days prior to enrolment)\n4. ECOG Performance Status 0-2\n5. Adequate end-organ function at screening (within 7 days of first study drug administration):\n\n   1. Serum creatinine ≤2 × ULN or CrCl ≥40 mL\u002Fmin (CKD-EPI formula)\n   2. ALT and AST ≤3 × ULN (≤5 × ULN if attributed to hepatic leukaemic infiltration)\n   3. Total bilirubin ≤1.5 × ULN (≤3 × ULN for Gilbert syndrome or hepatic leukaemic infiltration)\n   4. LVEF ≥45% by echocardiography or MUGA (assessed within 28 days of enrolment)\n6. Willing and able to provide written informed consent (patient or legally authorised representative for patients with AMS at presentation)\n7. Willingness to comply with all study procedures, including bone marrow assessments, follow-up visits, and MRD monitoring\n8. For women of childbearing potential (WOCBP): negative serum or urine pregnancy test within 72 hours of Cycle 1 Day 1, and agreement to use effective contraception throughout study treatment and for 12 months after last dose\n9. For male patients with female partners of childbearing potential: agreement to use effective contraception and refrain from sperm donation throughout treatment and for 6 months after last dose 5.2 Exclusion Criteria\n\n   Patients will be excluded from participation if ANY of the following apply:\n10. Acute promyelocytic leukaemia (APL) \\[t(15;17); PML-RARA\\]: patients with APL must be referred for ATRA-based therapy as per institutional standard\n11. AML secondary to myeloproliferative neoplasm (MPN) in blast phase, where prior MPN was treated with ruxolitinib within 8 weeks of enrolment (due to drug interaction potential with venetoclax)\n12. Prior exposure to a BCL-2 inhibitor (venetoclax, navitoclax, or other) at any time\n13. Prior exposure to HMA therapy (azacitidine or decitabine) for a pre-existing MDS or MPN within 6 months of AML diagnosis\n14. Active, uncontrolled systemic infection at the time of enrolment that in the investigator's judgement would preclude initiation of cytotoxic therapy (note: controlled infection with appropriate antimicrobial therapy is not an exclusion)\n15. Known active hepatitis B virus (HBV) infection (HBsAg positive) without established antiviral prophylaxis; or active hepatitis C virus (HCV) infection with detectable viral load\n16. Known HIV infection with CD4 count \\\u003C350 cells\u002FμL or detectable viral load (HIV-positive patients with well-controlled disease on antiretroviral therapy may be enrolled after discussion with the Principal Investigator and Infectious Disease consultant)\n17. Cardiac exclusions:\n\n    1. QTcF \\>480 ms on screening ECG\n    2. Clinically significant and uncontrolled arrhythmia\n    3. NYHA Class III-IV heart failure\n    4. Acute coronary syndrome or stroke within 6 months of enrolment\n18. Malabsorption syndrome or other gastrointestinal condition that would significantly impair oral absorption of venetoclax\n19. Concomitant strong CYP3A4 inhibitors (e.g. ketoconazole, posaconazole, voriconazole, clarithromycin) or inducers (e.g. rifampicin, phenytoin, carbamazepine) that cannot be safely discontinued or dose-adjusted. (Note: azole antifungals require venetoclax dose reduction per label - see Section 7.4)\n20. Concurrent active malignancy requiring systemic therapy (patients with adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix are eligible)\n21. Pregnancy or breastfeeding\n22. Participation in any other interventional clinical trial within 4 weeks of enrolment\n23. Any condition that, in the investigator's judgement, would compromise patient safety, protocol compliance, or the integrity of study data","50 Years",{"count":178,"type":23},60,[180],"PHASE2","Acute myeloid leukaemia (AML) is a clonal haematological malignancy characterised by arrested myeloid differentiation and uncontrolled proliferation of blast cells in the bone marrow and peripheral blood. It is the most common acute leukaemia in adults and carries a high disease-related mortality. Globally, the median age of diagnosis is approximately 68 years; however, a significant proportion of patients are diagnosed below the age of 50 years, constituting the 'young fit' population for whom aggressive curative-intent therapy is most appropriate.\n\nThe epidemiology of AML in South Asia and Pakistan remains incompletely characterised. Published single-centre and multi-centre data from Pakistan suggest that AML represents a major proportion of haematological malignancies presenting to tertiary centres. AFBMTC, as the largest haematology and transplant centre in Pakistan, has accumulated over 2,000 HSCT procedures since 2001 and has established the necessary infrastructure for prospective clinical research in this disease.\n\nCytogenetic and molecular classification of AML profoundly influences prognosis and treatment decisions. The European LeukemiaNet (ELN) 2022 risk stratification framework categorises AML into Favourable, Intermediate, and Adverse risk groups based on chromosomal abnormalities and somatic mutations including NPM1, FLT3-ITD, IDH1\u002F2, RUNX1, ASXL1, TP53, and others. This framework underpins post-remission pathway assignment in the current protocol.",[29,183],"AML (Acute Myeloid Leukemia)",[185],"AML, Azacytidine, Venetoclax, LMIC","NOT_YET_RECRUITING","2026-08-02",{"date":93,"type":38},{"date":190,"type":23},"2026-08-01",{"date":192,"type":23},"2027-12-31",{"name":194,"class":102},"Pakistan Blood and Marrow Transplant (PBMT) Group",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":24,"phases":205,"briefSummary":206,"conditions":207,"keywords":209,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100645598","phase-3-a-study-of-t-cell-receptor-engineered-donor-t-cells-in-subjects-undergoing-allogeneic-peripheral-blood-stem-cell-transplantation-100645598","NCT07702578","A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation","A Phase 1\u002F3 Study Evaluating the Efficacy and Safety of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation","ALLOHA-2","Subject Inclusion Criteria:\n\n1. Patient aged ≥ 18 years at the time of signing informed consent.\n2. Karnofsky Performance Status (KPS) ≥50 at the time of the screening visit.\n3. Undergoing first allo-HCT with a diagnosis of:\n\n   * AML with bone marrow blasts \\\u003C 5%, absence of circulating blasts, and absence of extramedullary disease.\n   * MDS\n4. Must express HLA-A\\*02:01 as determined by pre-transplant institutional SOC work-up to be eligible for the treatment arm.\n5. Must have the HA-2 positive genotype to be eligible for the treatment arm.\n6. Undergoing RIC HCT using a haplo donor or MMUD.\n\n   * Donors for treatment-arm subjects must be HLA-A\\*02-negative.\n   * Donors for control-arm subjects do not have to be HLA-A\\*02-negative.\n7. Undergoing use of PTCy for GvHD prophylaxis at standard doses.\n8. Use of peripheral blood stem cell source.\n9. Organ function parameters for transplant eligibility are met per institutional standards. Where organ function may fall outside of institutional standard for transplant, and patient is still proceeding to transplant, the case should be reviewed and approved by the MedicalMonitor.\n10. Patient or legally authorized representative (LAR) capable of giving signed informed consent and willingness to comply with the requirements and restrictions listed in the informed consent form (ICF) and clinical protocol.\n11. Agrees to participate in long-term follow-up (LTFU) for up to 15 years post the final infusion of TSC-101 if they receive a TSC-101 infusion.\n12. Contraceptive use by male and female subjects must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. At a minimum:\n\n    * A male subject must agree to use a highly effective contraceptive during the intervention period and for at least 12 months after the last TSC-101 infusion and refrain from donating sperm during this period.\n    * A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n\n      * Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR\n      * A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the intervention period and for at least 12 months after the last TSC-101 infusion.\n\nSubject Exclusion Criteria:\n\nPatients are excluded from the study if any of the following criteria apply:\n\n1. Potential treatment-arm patient is positive for HLA-A\\*02:07.\n\n   • Patients considered for the control arm can be positive for HLA-A\\*02 (including HLA-A\\*02:07).\n2. For patients with AML: those in third complete remission (CR3) or greater, partial remission, or with active AML disease.\n3. If patient required hemodialysis or mechanical ventilation within 3 months prior to enrollment, circumstances must be discussed with the Sponsor Medical Monitor.\n4. Prior allo-HCT.\n5. Use of anti-thymocyte globulin (ATG), alemtuzumab, or other in vivo or ex vivo T-cell depleting agents from Day -14 (pre-HCT) through end of study (EOS). Corticosteroids and maintenance therapies may be allowed under certain circumstances.\n6. History of hypersensitivity to murine proteins.\n7. Enrollment in a concomitant study with an investigational agent. All other concomitant trials must be reviewed and approved by the Medical Monitor.\n8. Cardiac disease, defined as:\n\n   * Uncontrolled or symptomatic angina within the past 3 months.\n   * History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.\n   * Myocardial infarction \\\u003C 6 months from study entry.\n   * Uncontrolled or symptomatic congestive heart failure.\n   * Cardiac ejection fraction at rest of less than 40% or shortening fraction of less than 22% by echocardiogram or radionuclide scan (multi-gated acquisition \\[MUGA\\] scan).\n9. Medical or psychological conditions that would make the patient an unsuitable candidate for participation on a cell therapy trial, including active central nervous system disease and\u002For prior malignancy(s) within the last 3 years, except:\n\n   * Lobular breast carcinoma in situ, fully resected basal cell or squamous cell carcinoma of skin or treated cervical carcinoma in situ will be allowed. Cancer treated with curative intent ≥ 3 years previously will be allowed\n\nDonor Inclusion Criteria:\n\n1. Male or female ≥ 50 kg and aged ≥ 16 years at the time of signing informed consent who meet the criteria to donate as per the institutional SOC.\n2. Capable of giving signed informed consent, or assent\u002Fparental consent per institutional SOC, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n3. For treatment-arm donors: able to undergo peripheral blood stem cell (PBSC) collection and at least 2 rounds of leukapheresis (for both TSC-101 manufacturing and the stem cell collection for HCT).\n4. For treatment-arm donors: negative for all HLA-A\\*02 alleles • Donors for control-arm subjects do not have to be negative for HLA-A\\*02 alleles.\n\nDonor Exclusion Criteria:\n\n1. Donors for control-arm subjects who do not meet institutional standards for donor selection.\n2. Donors for treatment-arm subjects:\n\n   * Who test positive for any of the following: 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, syphilis, West Nile virus through central lab testing. Donors who screen positive for Creutzfeldt Jakob disease using donor history questionnaires will also be excluded. Donors with evidence of past cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infections will be allowed.\n   * For whom the treating Investigator deems subject level donor-specific HLA antibodies are high enough to warrant treatment with desensitization protocols.",{"count":204,"type":23},310,[115],"This is a multicenter, genetically-randomized, controlled, Phase 3 study evaluating the efficacy and safety of T-cell receptor-engineered donor T cells targeting HA-2 (TSC-101) administered following reduced-intensity conditioning (RIC) hematopoietic cell transplantation (HCT) in participants with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The study will compare TSC-101 plus standard of care (SOC) versus SOC alone in participants undergoing allogeneic peripheral blood stem cell transplantation from haploidentical or mismatched unrelated donors.",[29,208],"MDS",[210,211,29,208,212,213,214,215,216,217,218,219,220,201,221,222,223],"HA-2","TSC-101","Adoptive Cell Therapy","T-cell receptor","T lymphocyte","TCR-engineered T cells","bone marrow transplant","haploidentical","allogenic stem cell transplant","BMT","RIC","Mismatched unrelated donors MMUD","HCT","Hematopoietic cell transplantation","2026-07-20",{"date":226,"type":38},"2026-07-22",{"date":228,"type":38},"2026-06-18",{"date":230,"type":23},"2029-06",{"name":232,"class":45},"TScan Therapeutics, Inc.",26,{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":24,"phases":243,"briefSummary":244,"conditions":245,"keywords":246,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},"100475667","phase-1-a-phase-13-study-of-t-cell-receptor-engineered-donor-t-cells-in-subjects-undergoing-allogeneic-peripheral-blood-stem-cell-transplantation-100475667","NCT05473910","A Phase 1\u002F3 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation","A Phase 1\u002F3 Study Evaluating the Efficacy and Safety of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)","ALLOHA","Inclusion Criteria:\n\n* Male or female aged ≥ 18 years at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit.\n* Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Male Participants:\n* A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.\n* Female Participants:\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:\n* Not a woman of childbearing potential (WOCBP) OR\n* A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 12 months after the last dose of study intervention.\n* Preparing to undergo allogeneic HCT for either of the following:\n* AML, MDS, ALL\n* Participants in the treatment arms must express HLA-A\\*0201. Participants in the control arm may express any HLA type.\n* Having the HA1+\u002F- or HA-1+\u002F+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.\n* Having the HA2+\u002F- HA-2+\u002F+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.\n* Having a haploidentical donor, MMUD, or MUD for HCT who is adequately HLA-matched by institutional standards and meets the donor inclusion criteria.\n\nConsidered to be clinically indicated for haploidentical donor, MMUD, or MUD transplantation at the discretion of the treating investigator.\n\nConsidered to be clinically indicated for RIC at the discretion of the treating investigator.\n\nConsidered to be clinically indicated for peripheral blood stem cell transplantation at the discretion of the treating investigator.\n\nOrgan function parameters for transplant eligibility are met per institutional standards.\n\nCapable of giving signed informed consent - which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nParticipants must provide consent for mandatory study procedures including bone marrow biopsy and blood sampling for research analyses in the ICF.\n\nParticipants must agree to participate in long-term follow-up for up to 15 years post initial product treatment if they are enrolled in the study and receive the investigational Tcell infusion.\n\nDonor Inclusion Criteria :\n\nMale or female aged ≥ 18 years at the time of signing the informed consent. Able to undergo peripheral blood stem cell (PBSC) collection and up to 2 rounds of leukapheresis (for TSC-100 or TSC101 manufacturing for treatment arms only, and f for stem cell collection for both treatment arms and the control arm).\n\nDonors matched to TSC-100 participants should be HA-1-\u002F- (negative) and\u002For negative for all HLA-A\\*02 alleles Donors matched to TSC-101 participants should be negative for all HLA-A\\*02 alleles Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria:\n\nMedical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent uncontrolled malignancy or active CNS disease.\n\nThe presence of organ toxicities will not necessarily exclude participants from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA1\u002FHA2 TCRT cells may be required at the discretion of the treating investigator Participants with levels of donor-specific HLA antibodies that are considered by the treating investigator to be high enough to warrant desensitization protocols and who have no alternate donors.\n\nParticipants who meet inclusion criteria for TSC-101 but who are also positive for HLAA\\*02:07.\n\nParticipants with evidence of clinically significant infection or uncontrolled viral r reactivation of cytomegalovirus (CMV), Epstein-Barr virus (EBV), Adenovirus, BK virus (BKV), or human herpesvirus 6 (HHV-6).\n\nParticipants with active cardiac disease, defined as:\n\nUncontrolled or symptomatic angina within the past 3 months. History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.\n\nMyocardial infarction \\\u003C 3 months from study entry. Uncontrolled or symptomatic congestive heart failure. Prior allogeneic HCT. Participants who have a history of hypersensitivity to murine proteins. Enrollment on a concomitant trial with a novel investigational agent. Use of anti-thymocyte globulin, alemtuzumab, or other in vivo T-cell depleting agents from Day -14 through end of study.\n\nDonor Exclusion Criteria :\n\nDonors for TSC-100 positive for any HLA-A\\*02 allele would be excluded unless they are HA-1 negative. If donors with any HLA-A\\*02 allele are considered for patients eligible for TSC-100, the donor would undergo HA-1 testing to ensure that the donor is HA-1 negative (40% probability).\n\nDonors for TSC-101 positive for any HLA-A\\*02 allele are excluded regardless of HA- 2 status.\n\nDonors who test positive for any of the following: HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection, syphilis, West Nile virus through central lab testing. Donors who screen positive for risk of CreutzfeldtJakob disease or Zika virus infection using donor history questionnaires will also be excluded. Donors with evidence of past CMV or EBV infections will be allowed.\n\nRelated donor residing outside of the United States of America (USA). If the donor screening, testing and leukapheresis can be performed at the same site where the participant is being treated, the donor is considered eligible.",{"count":204,"type":23},[26],"This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MMUD, or MUD",[29,208],[210,211,29,208,212,213,214,215,216,217,247,219,220,248,249,201,221,240,250,251,18,252],"allogeneic stem cell transplant","HSCT","Hematopoietic stem cell transplantation","HA-1","TSC-100","Reduced Intensity Conditioning","2026-07-17",{"date":255,"type":38},"2026-07-21",{"date":257,"type":38},"2022-11-01",{"date":259,"type":23},"2028-06",{"name":232,"class":45},21,{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":269,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":273,"phases":4,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":284,"leadSponsor":286,"locationsCount":4},"100646147","model-informed-precision-dosing-on-cyclosporine-therapy-in-hematopoietic-stem-cell-transplant-recipients-100646147","NCT07695571","Model-Informed Precision Dosing on Cyclosporine Therapy in Hematopoietic Stem Cell Transplant Recipients","Hybrid Population Pharmacokinetic,Machine Learning and Deep Learning Modelling to Predict Dosing for the Individualization of Cyclosporine Therapy in Transplant Recipients","Inclusion Criteria:\n\n* • CsA therapy indicated alone or in combination for GVHD prophylaxis.\n\n  * Aged 2-65 years.\n  * Clinically stable after first HSCT.\n\nExclusion Criteria:\n\n* • Inaccurate sampling or dose administration times.\n\n  * Patients with missing key covariates.\n  * Patients lacking sufficient pharmacokinetic or TDM data","2 Years","65 Years",{"count":272,"type":23},300,"OBSERVATIONAL","The purpose of this study is to develop a new tool that helps doctors choose the right cyclosporine dose for patients undergoing bone marrow transplantation. The tool is designed to predict the best dose using sparse sampling, making it practical for everyday clinical care. It combines information about population pharmacokinetics of cyclosporine with advanced artificial intelligence techniques, including machine learning and deep learning. This tool aims to improve treatment, personalize dosing for each patient, and reduce the risk of graft-versus-host disease.",[276,29],"Bone Marrow Transplantation",[278,279],"Clinical Pharmacokinetics","Machine learning","2026-07-08",{"date":282,"type":38},"2026-07-10",{"date":190,"type":23},{"date":285,"type":23},"2027-06-01",{"name":287,"class":102},"Yasmin medhat munir Mohamed",{"id":289,"slug":290,"hasResults":12,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":24,"phases":297,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":312},"100641694","phase-1-a-study-of-crd3874-si-in-people-with-leukemia-100641694","NCT07661095","A Study of CRD3874-SI in People With Leukemia","A Phase 1 Study of the STING Agonist CRD3874-SI for Relapsed and Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documentation of Disease\n\n  o Participant has relapsed or refractory acute myeloid leukemia, defined as bone marrow blasts ≥ 5%, and\u002For reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, and\u002For development of extramedullary disease; or, no CR, CRh or CRi at response assessment after at least 1 line of therapy, as defined by standardized European LeukemiaNet 2022 Criteria. Patients must have failed treatment with available therapies known to be active for treatment of their AML.\n* Participant must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n* Participant must weigh at least 40 kg\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (See Appendix I for performance status criteria)\n* For patients with known HIV, HBV, and\u002For HCV infection \\[HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and\u002For HCV infection\\]:\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Required Organ Function\n\n  * Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n  * Serum total bilirubin \\\u003C 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  * Calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin by Cockcroft-Gault formula or CKD-EPI 2021 or estimated glomerular filtration rate 60 mL\u002Fmin or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).\n  * Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram.\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Participants with isolated myeloid sarcoma\n* Blast phase of chronic myeloid leukemia\n* Known active central nervous system leukemia\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.\n* Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n* Participants with concurrent other malignancy that will confound interpretation of study endpoints.\n* Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below\n\n  1. Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.\n  2. Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.\n  3. Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment\n* Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.\n* Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG; National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] v6.0 Grade ≥ 3)\n* Prior organ transplantation, other than allogeneic or autologous hematopoietic stem cell transplantation.\n* Received a live vaccine within 30 days of the planned start of study drug.\n\n  a. (Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.)\n* Evidence of clinically significant immunosuppression including the following:\n\n  a. Primary immunodeficiency state such as SCID b. Concurrent opportunistic infection c. Receiving systemic immunosuppressive therapy (\\>2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within seven days prior to enrollment. In the setting of non-immune mediated indications for use, chronic\u002Factive low dose steroid use (equivalent to ≤ 10 mg\u002Fday prednisone) may be permitted at the discretion of the Principal Investigator i. (Note: Other steroid formulations or steroid use for other indications may be permitted and include: 1) Intranasal, inhaled, ocular, or topical steroids, or local steroid injection (e.g., intra-articular injection); 2) Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; 3) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past two years prior to enrollment\n\n  a. (Note: Replacement therapy \\[e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency\\] is not considered a form of systemic treatment for autoimmune disease.)\n* Evidence of clinically significant interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis related to prior immunotherapy treatment\n* Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke.\n* Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 470 ms. Patients with a QTcF over 470 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.\n* Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n* Participant with active use of strong or moderate CYP3A4 inhibitors.\n* Female participant who is pregnant or lactating.\n* Because STING agonist agents impact immune and cellular functioning posing potential risk for impacting normal embryonic development, and because other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy. Male or female participants not willing to comply with contraceptive requirements will be excluded, which adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy",{"count":296,"type":23},24,[26],"The purpose of this study is to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).",[30,29,31],[30,29,31,301,302,303],"CRD3874-SI","Memorial Sloan Kettering Cancer Center","26-144","2026-06-16",{"date":306,"type":38},"2026-06-22",{"date":308,"type":38},"2026-06-15",{"date":310,"type":23},"2028-06-15",{"name":302,"class":102},7,{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":273,"phases":4,"briefSummary":322,"conditions":323,"keywords":367,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":103},"100289631","familial-investigations-of-childhood-cancer-predisposition-100289631","NCT03050268","Familial Investigations of Childhood Cancer Predisposition","SJFAMILY","NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown below, you may enroll regardless of the results of your clinical genetic testing.\n\nDEFINITION OF FAMILIAR CANCER FOR THIS PROTOCOL:\n\nIn this protocol, the definition of \"Familial Cancer\" is met if any of the following is present:\n\n* An individual with a history of cancer diagnosed under 26 years of age who has at least one first, second or third degree relative with a history of cancer diagnosed under 51 years of age; OR\n* An individual who has been diagnosed with more than one cancer, at least one of which was diagnosed under 26 years of age; OR\n* An individual with a clinical or molecular diagnosis of a known cancer predisposition syndrome; OR\n* An individual with a congenital cancer diagnosed before 6 months of age; OR\n* An individual with a rare pediatric cancer or tumor diagnosed before 26 years of age\n\nº Excluding human papilloma virus-associated cervical cancer and non-melanoma skin cancer occurring in adults.\n\nINCLUSION CRITERIA:\n\n* An individual who meets this protocol's definition of \"Familial Cancer,\" as above.\n* Biologic relatives of an individual meeting this protocol's definition of \"Familial Cancer,\" who are either affected or unaffected by cancer.\n\nEXCLUSION CRITERIA:\n\n* An inability or unwillingness of the research participant or his\u002Fher legally authorized representative (LAR) to provide written informed consent.\n* The participant has received allogeneic bone marrow transplantation and has NO pre-transplant germline (cancer-unaffected) DNA available AND is unwilling to provide a skin sample.",{"count":321,"type":23},1500,"NOTE: This is a research study and is not meant to be a substitute for clinical genetic testing. Families may never receive results from the study or may receive results many years from the time they enroll. If you are interested in clinical testing please consider seeing a local genetic counselor or other genetics professional. If you have already had clinical genetic testing and meet eligibility criteria for this study as shown in the Eligibility Section, you may enroll regardless of the results of your clinical genetic testing.\n\nWhile it is well recognized that hereditary factors contribute to the development of a subset of human cancers, the cause for many cancers remains unknown. The application of next generation sequencing (NGS) technologies has expanded knowledge in the field of hereditary cancer predisposition. Currently, more than 100 cancer predisposing genes have been identified, and it is now estimated that approximately 10% of all cancer patients have an underlying genetic predisposition.\n\nThe purpose of this protocol is to identify novel cancer predisposing genes and\u002For genetic variants. For this study, the investigators will establish a Data Registry linked to a Repository of biological samples. Health information, blood samples and occasionally leftover tumor samples will be collected from individuals with familial cancer. The investigators will use NGS approaches to find changes in genes that may be important in the development of familial cancer. The information gained from this study may provide new and better ways to diagnose and care for people with hereditary cancer.\n\nPRIMARY OBJECTIVE:\n\n* Establish a registry of families with clustering of cancer in which clinical data are linked to a repository of cryopreserved blood cells, germline DNA, and tumor tissues from the proband and other family members.\n\nSECONDARY OBJECTIVE:\n\n* Identify novel cancer predisposing genes and\u002For genetic variants in families with clustering of cancer for which the underlying genetic basis is unknown.",[67,324,325,29,326,327,328,329,330,331,332,333,334,335,336,337,338,339,340,341,342,343,344,345,346,208,347,348,349,350,351,352,353,354,355,356,357,358,359,360,361,362,363,364,365,366],"Adenomatous Polyposis","Adrenocortical Carcinoma","BAP1 Tumor Predisposition Syndrome","Carney Complex","Choroid Plexus Carcinoma","Constitutional Mismatch Repair Deficiency Syndrome","Diamond-Blackfan Anemia","DICER1 Syndrome","Dyskeratosis Congenita","Emberger Syndrome","Familial Acute Myeloid Leukemia","Familial Adenomatous Polyposis","Fanconi Anemia","Familial Cancer","Familial Wilms Tumor","Familial Neuroblastoma","GIST","Hereditary Breast and Ovarian Cancer","Hereditary Paraganglioma-Pheochromocytoma Syndrome","Hodgkin Lymphoma","Juvenile Polyposis","Li-Fraumeni Syndrome","Lynch Syndrome","Melanoma Syndrome","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Neuroblastoma","Neurofibromatosis Type 1","Neurofibromatosis Type II","Nevoid Basal Cell Carcinoma Syndrome","Non Hodgkin Lymphoma","Noonan Syndrome and Other Rasopathy","Overgrowth Syndromes","Pancreatic Cancer","Peutz-Jeghers Syndrome","Pheochromocytoma\u002FParaganglioma","PTEN Hamartoma Tumor Syndrome","Retinoblastoma","Rhabdoid Tumor Predisposition Syndrome","Rhabdomyosarcoma","Rothmund-Thomson Syndrome","Tuberous Sclerosis","Von Hippel-Lindau Disease",[368,369,370,371,372,373,374,375,376],"Familial cancer","Genetic predisposition","Heritable disease","Cancer risk","Genome analysis","Genetic modifiers","Next generation sequencing (NGS)","Genetic counseling","DNA",{"date":378,"type":38},"2026-06-17",{"date":380,"type":38},"2017-04-06",{"date":382,"type":23},"2037-03-31",{"name":384,"class":102},"St. Jude Children's Research Hospital",{"id":386,"slug":387,"hasResults":12,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":12,"sex":18,"minAge":392,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":273,"phases":4,"briefSummary":396,"conditions":397,"keywords":411,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":424},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212","NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","0 Years","38 Years",{"count":395,"type":23},30,"The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[60,64,398,399,18,400,29,401,402,403,354,343,404,405,406,407,408,409,410],"Lymphoma","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","Chronic Myelogenous Leukemia","CML","Myeloproliferative Neoplasm","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[412,413,414],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","2026-06-02",{"date":417,"type":38},"2026-06-04",{"date":419,"type":38},"2023-11-15",{"date":421,"type":23},"2027-12-01",{"name":423,"class":102},"Children's Hospital Medical Center, Cincinnati",5,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":4,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":24,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":103},"100632076","phase-1-phase1b2-trial-of-aza--apg1252-in-patients-with-high-risk-aml-100632076","NCT07508982","Phase1b\u002F2 Trial Of AZA + APG1252 In Patients With High-Risk AML","Inclusion Criteria:\n\n1. Part I, Lead-in phase and Part II, Cohort A:\n\n   Patients with relapsed and\u002For refractory AML Patients with high-risk MDS\u002FAML who have had prior therapy will also be included\n2. Part II, Cohort B\n\n   Patients with untreated, newly diagnosed AML of the following subtypes:\n   * AML-M6 or AML-M7 by FAB or having erythroid or megakaryocytic differentiation by WHO 2022 classification\n   * High-risk MDS\u002FAML with erythroid differentiation and no prior therapy\n   * AML with MECOM rearrangement, including, but not limited to t(3;3), inv(3q), confirmed by conventional karyotype or FISH for MECOM rearrangement.\n3. Age \\>\u002F= 18 years. Because no dosing or adverse event data are currently available on the use of APG1252 in combination with AZA in patients \\\u003C18 years of age, children are not included in this study at this time.\n4. Adequate organ function as defined below:\n\n   Liver function (bilirubin \\\u003C 2mg\u002FdL, AST and ALT \\\u003C3 x ULN - or ≤5 x ULN if related to leukemic involvement) Kidney function (estimated creatinine clearance \\> 50 mL\u002Fmin). Known cardiac ejection fraction of \\> or = 45% within the past 3 months\n5. ECOG performance status of ≤ 2.\n6. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n7. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n\nThe effects of APG1252 on the developing human fetus are unknown. For this reason and because BCL-2\u002FBCL-XL inhibitors as well as 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n\nApproved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n\nMen 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 completion of APG1252 administration. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Pregnant women are excluded from this study because the agent used in this study has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided. 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure.\n2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n3. Patient with documented hypersensitivity to any of the components of the therapy program.\n4. Patients with known active, uncontrolled CNS leukemia will not be eligible.\n5. Patients with prior treatment with a BCL-XL inhibitor will not be eligible.\n6. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.\n7. Known history of human immunodeficiency virus (HIV) infection (HIV 1\u002F2 antibodies) unless HIV RNA is undetectable by PCR.\n8. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. Hepatitis B virus DNA and HCV RNA must be undetectable upon testing. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.",{"count":432,"type":23},52,[26,180],"This is a phase Ib\u002FII study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML.",[29],"2026-05-29",{"date":415,"type":38},{"date":439,"type":38},"2026-05-22",{"date":441,"type":23},"2031-12-12",{"name":443,"class":102},"M.D. Anderson Cancer Center",{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":451,"enrollmentInfo":452,"targetDuration":4,"studyType":24,"phases":453,"briefSummary":454,"conditions":455,"keywords":457,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":466,"locationsCount":103},"100640378","phase-1-allogeneic-car-tct0890b-in-nkg2dl-rr-aml-100640378","NCT07617285","Allogeneic CAR-T(CT0890B) in NKG2DL+ R\u002FR AML","A Phase I Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cells (CT0890B) in Patients With NKG2DL-Positive Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Age 18-70 years (inclusive), male or female.\n2. Relapsed or refractory acute myeloid leukemia (R\u002FR AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease.\n3. Bone marrow blasts ≥5% by morphology.\n4. Estimated life expectancy \\>12 weeks.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n6. Adequate organ function without ongoing supportive care, defined as:\n\n   1. Cardiac: left ventricular ejection fraction (LVEF) ≥50%;\n   2. Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;\n   3. Renal: creatinine clearance ≥30 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n   4. Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.\n\n   c) Renal: creatinine clearance ≥30 mL\u002Fmin (calculated using the Cockcroft-Gault formula); d) Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN.\n\nExclusion Criteria:\n\n1. Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;\n2. Participants with a history of epilepsy or other central nervous system disease;\n3. Participants who have previously received autologous or allogeneic CAR-T therapy;\n4. Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks\n5. Participants who have received prior immunotherapy targeting NKG2DL;\n6. Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;\n7. Participant has any of the following at screening:\n\n1)Active, uncontrolled systemic infection or requiring intravenous anti-infective agents 2)Any of the following cardiac conditions, including:\n\n1. New York Heart Association Class III-IV heart failure;\n2. History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;\n3. History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;\n4. History of severe nonischemic ardiomyopathy;\n5. Other cardiac disease that the investigatorbelieve could jeopardize the participant 's well-being or compromise participation in this clinical trial; 3) Active bleeding of clinical significance as judged by the investigator; 4)Requiring supplemental oxygen to maintain oxygen saturation\\> 92%; 5)Patients with severe chronic obstructive pulmonary disease (COPD) or other lung diseases that cannot tolerate CAR-T treatment as judged by the investigator;","70 Years",{"count":88,"type":23},[26],"A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed\u002FRefractory Acute Myeloid Leukemia.",[29,456],"Refractory\u002FRelapse Acute Myeloid Leukemia",[458,459,29],"CT0890B","Universal CAR-T","2026-05-23",{"date":462,"type":38},"2026-06-01",{"date":464,"type":23},"2026-05-07",{"date":42,"type":23},{"name":467,"class":102},"Peking University People's Hospital",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":270,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":24,"phases":477,"briefSummary":478,"conditions":479,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":103},"100590918","phase-2-a-randomized-study-to-compare-post-transplant-cyclophosphamide-sirolimus-ruxolitinib-and-post-transplant-cyclophosphamide-sirolimus-mycophenolate-mofetil-to-prevent-graft-versus-host-disease-100590918","NCT06973668","A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease","Inclusion Criteria:\n\n1. Age ≥ 65 and \\\u003C 75 years are eligible if they have one of the following diseases.\n\n   1. Acute Myeloid Leukemia\n   2. Myelodysplastic syndrome\n   3. Chronic myelomonocytic leukemia\n2. Available HLA-identical or haploidentical related donor or a 7\u002F8 or 8\u002F8 HLA matched unrelated donor.\n3. Peripheral blood stem cells as a graft source\n4. Subject must voluntarily sign an informed consent.\n5. Adequate organ function per local laboratory reference range as follows: - Aspartate transaminase (AST) and alanine transaminase (ALT) \\\u003C 3.0X ULN - Total Bilirubin \\\u003C1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin) - Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 40 mL\u002Fmin\u002F1.73 m2 (as reported in epic using 2021 CKD-EPI creatinine equation)\n\n   * DLCO corrected for Hgb, if applicable) ≥ 50% of predicted\n   * Ejection Fraction ≥ 50%\n   * The effects on the developing human fetus are unknown. For this reason and as well as 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. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n     * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n     * History of hysterectomy or bilateral salpingo-oophorectomy.\n     * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n     * History of bilateral tubal ligation or another surgical sterilization procedure.\n\nApproved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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.\n\nMen 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 completion of study agent administration.\n\nExclusion Criteria:\n\n1. Subject is known to be positive for HIV.\n2. Subject has acute promyelocytic leukemia.\n3. Subject has known active CNS involvement with AML.\n4. Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score of \\>5\n5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:\n\n   1. Uncontrolled and\u002For active systemic infection (viral, bacterial or fungal)\n   2. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or subjects with positive anti-HBc antibody but negative Hep B DNA may participate.\n6. Cardiac history of CHF requiring treatment or Ejection Fraction \\\u003C 50% or unstable angina or MI within 1 year of study entry\n7. Major adverse cardiac events such as MI\u002Fstroke and pulmonary embolism (PE)\u002Fdeep vein thrombosis (DVT) within 6 months. Recent history of Central line-associated DVT may be allowed after discussion with PI.\n8. Current and\u002For history of active TB\n9. White Blood Cell count \\> 25 X 109 \u002FL.\n10. Pregnant women are excluded from this study because the study agent has unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with the study agent. These potential risks may also apply to other agents used in this study.","75 Years",{"count":476,"type":23},80,[180],"The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.",[29],"2026-05-18",{"date":482,"type":38},"2026-05-20",{"date":484,"type":38},"2025-07-22",{"date":486,"type":23},"2030-01-31",{"name":443,"class":102},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":496,"targetDuration":4,"studyType":24,"phases":498,"briefSummary":499,"conditions":500,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":504,"startDateStruct":506,"completionDateStruct":508,"leadSponsor":510,"locationsCount":103},"100563105","phase-1-venetoclax-in-combination-with-ivosidenib-and-azacitidine-for-newly-diagnosed-idh1-mutated-aml-100563105","NCT06611839","Venetoclax in Combination With Ivosidenib and Azacitidine for Newly Diagnosed IDH1-Mutated AML","A Multicenter, Single-Arm Clinical Study of the Venetoclax, Ivosidenib, and Azacitidine Triple-Drug Regimen in the Treatment of Chemotherapy-eligible Adult Patients With IDH1-Mutated Acute Myeloid Leukemia.","IDH1-AML-2024","Inclusion Criteria:\n\n1. Patients who meet AML according to WHO (2022) or AML and MDS\u002FAML defined by ICC standards with IDH1 mutations detected by PCR or second-generation sequencing.\n2. Age ≥14 years old, male or female.\n3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.\n4. Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :\n\n   1. Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);\n   2. AST and ALT≤ 2.5 times the upper limit of normal value (same age);\n   3. Blood creatinine \\&amp;lt; 2 times the upper limit of normal (same age);\n   4. Myocardial enzymes \\&amp;lt; 2 times the upper limit of normal (same age);\n   5. Left ventricular ejection fraction \\&amp;gt;50% by measure of echocardiogram (ECHO) Informed consent must be signed before the commencement of all specific study procedures, and is signed by the patient himself or his immediate family. Considering the patient\\&amp;#39;s condition, if the patient\\&amp;#39;s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\\&amp;#39;s immediate family.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are excluded from the study:\n\n1. Acute promyelocytic leukemia with PML-RARA fusion gene\n2. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene\n3. Acute myeloid leukemia with BCR-ABL fusion gene\n4. Treated patients (but can receive hydroxyurea or cytarabine to lower tumor burden).\n5. Concurrent malignant tumors of other organs (those requiring treatment).\n6. Active heart disease, defined as one or more of the following:\n\n   1. A history of uncontrolled or symptomatic angina;\n   2. Myocardial infarction less than 6 months after enrollment;\n   3. Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;\n   4. Uncontrolled or symptomatic congestive heart failure (\\&amp;gt; NYHA level 2);\n7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).\n8. Those who were not considered suitable for inclusion by the researchers.",{"count":497,"type":23},23,[26,180],"Venetoclax can bind to the BCL-2 protein, thereby initiating the apoptosis program and exerting anti-AML effects. The induction regimen combining venetoclax with hypomethylating agents (HMA) significantly improves the remission rate (over 60%) in elderly unfit AML patients and markedly prolongs survival in those achieving complete remission. Isocitrate dehydrogenase (IDH) 1 and 2 are involved in the citric acid cycle. Approximately 20% of AML patients carry IDH1 or IDH2 mutations, which lead to the reduction of α-ketoglutarate to 2-hydroxyglutarate (2-HG). 2-HG can cause histone methylation and inhibit TET2 activity, resulting in DNA hypermethylation, thereby affecting gene expression and cell differentiation. IDH mutations are more common in elderly patients and are often associated with cytogenetic abnormalities; they may also co-occur with FLT3-ITD, NPM1, or DNMT3A mutations. Ivosidenib is an IDH1 inhibitor, and previous studies have confirmed its safety and efficacy in AML treatment. According to adult AML treatment guidelines, IDH-mutated patients eligible for intensive chemotherapy may receive IDH inhibitors during induction therapy. Based on the study by Montesinos et al. on the role of ivosidenib and azacitidine in IDH-mutated AML, for patients ineligible for intensive chemotherapy, a new treatment option has been added: IDH1-mutated AML patients may receive ivosidenib (500 mg, days 1-28) combined with azacitidine (75 mg\u002Fm²\u002Fday for 7 days) in 28-day cycles, or ivosidenib monotherapy. Recent studies have shown that a triple-drug regimen comprising ivosidenib, venetoclax, and azacitidine demonstrates excellent efficacy and safety. In chemotherapy-ineligible patients, the triple regimen achieved a composite complete remission rate (CRc) of 86% and an overall response rate (ORR) of 92%. At a median follow-up of 27.4 months, the 2-year overall survival (OS) was 72%, and the 2-year event-free survival (EFS) was 72%. Therefore, this study aims to conduct a multicenter, single-arm clinical trial to preliminarily evaluate the long-term efficacy of this combination in adult AML.",[29,501,502],"IDH1 Mutation","Treatment","2026-05-10",{"date":505,"type":38},"2026-05-13",{"date":507,"type":38},"2025-10-17",{"date":509,"type":23},"2028-10-01",{"name":101,"class":102},{"id":512,"slug":513,"hasResults":12,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":517,"eligibilityCriteria":518,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":4,"enrollmentInfo":519,"targetDuration":4,"studyType":24,"phases":521,"briefSummary":522,"conditions":523,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":503,"lastUpdatePostDateStruct":525,"startDateStruct":526,"completionDateStruct":528,"leadSponsor":530,"locationsCount":103},"100559265","phase-1-the-efficacy-of-triple-regimen-in-newly-diagnosed-aml-patients-with-flt3-mutation-100559265","NCT06561880","The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation","The Efficacy of a Triple Regimen Including Gilteritinib, Venetoclax, and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation","FLT3AML-2024","Inclusion Criteria:\n\n1. MDS\u002FAML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.\n2. Age ≥15 years old, male or female.\n3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.\n4. Pass the requirements of the following laboratory tests (performed within 7 days before treatment) :\n\n1\\) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times the upper limit of normal value (same age); 3) Blood creatinine \\\u003C 2 times the upper limit of normal (same age); 4) Myocardial enzymes \\\u003C 2 times the upper limit of normal (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia with PML-RARA fusion gene\n2. Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene\n3. Acute myeloid leukemia with BCR-ABL fusion gene\n4. Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy).\n5. Concurrent malignant tumors of other organs (those requiring treatment).\n6. Active heart disease, defined as one or more of the following:\n\n1\\) A history of uncontrolled or symptomatic angina; 2) Myocardial infarction less than 6 months after enrollment; 3) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (\\> NYHA level 2); 5) The ejection fraction is lower than the lower limit of the normal range. 7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 8. Those who were not considered suitable for inclusion by the researchers.",{"count":520,"type":23},66,[26,180],"The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.",[524,29],"FLT3 Gene Mutation",{"date":505,"type":38},{"date":527,"type":38},"2024-10-08",{"date":529,"type":23},"2027-08-31",{"name":101,"class":102},{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":538,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":539,"targetDuration":4,"studyType":273,"phases":4,"briefSummary":541,"conditions":542,"keywords":544,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":103},"100638844","biomarkers-in-bone-marrow-supernatant-for-predicting-aml-chemosensitivity-100638844","NCT07587944","Biomarkers in Bone Marrow Supernatant for Predicting AML Chemosensitivity","Bone Marrow Microenvironment Signatures for Predicting AML Prognosis and Resistance","Inclusion Criteria:\n\n1. Clinical diagnosis aligns with the \"Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)\";\n2. All patients are experiencing their first onset of the disease and have not received any related chemotherapy prior to the study;\n3. Patients participate in the study accompanied by family members and sign informed consent documents.\n\nExclusion Criteria:\n\n1. Patients with concurrent malignancies requiring treatment;\n2. Presence of infectious diseases, including SARS, viral hepatitis, or HIV\u002F AIDS;\n3. Major surgery performed within the last 21 days;\n4. Performance Status (PS) score \\>3;\n5. Severe liver or kidney dysfunction or serious infection;\n6. Severe psychiatric conditions that impair understanding of the study protocol or voluntary withdrawal.",true,{"count":540,"type":23},405,"Chemoresistance in acute myeloid leukemia (AML) is closely associated with the bone marrow microenvironment. Elevated levels of IL-6, leptin, fumarate, and other factors within the bone marrow microenvironment have been shown to enhance oxidative phosphorylation or antioxidant capacity in AML cells, thereby inducing chemoresistance. To explore their potential as prognostic biomarkers or therapeutic targets, this study plans to enroll 405 newly diagnosed AML patients meeting the criteria of the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2023 Edition), along with 81 sex- and age-matched healthy controls. By analyzing the levels of IL-6, leptin, fumarate, and other factors in patient bone marrow supernatant, we will evaluate their associations with treatment response (primary endpoints: overall survival \\[OS\\] and overall response rate \\[ORR\\] after one cycle of chemotherapy) and prognosis. Furthermore, patient-derived xenograft (PDX) mouse models established from primary AML cells will be used to validate their roles in chemoresistance, aiming to provide a basis for therapies targeting the bone marrow microenvironment.",[29,543],"Adult",[29,545,546,547,548,549],"Chemosensitivity","Biomarker","Fumarate","Leptin","IL-6",{"date":551,"type":38},"2026-05-14",{"date":553,"type":38},"2025-12-01",{"date":555,"type":23},"2030-01-01",{"name":557,"class":102},"Fujian Medical University Union Hospital",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":24,"phases":568,"briefSummary":569,"conditions":570,"keywords":574,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":103},"100528289","phase-1-pilot-study-of-memory-like-natural-killer-ml-nk-cells-after-tcr-t-cell-depleted-haploidentical-transplant-in-aml-100528289","NCT06158828","Pilot Study of Memory-like Natural Killer (ML NK) Cells After TCRαβ T Cell Depleted Haploidentical Transplant in AML","A Phase I\u002FII Pilot Study of Memory-like NK Cells to Consolidate TCRαβ T Cell Depleted Haploidentical Transplant in High-risk AML","ABCD-NK","Patient Inclusion Criteria - Cohort 1:\n\n1. High risk acute myeloid leukemia (AML) in either:\n\n   1. Complete remission (CR) defined by \\\u003C 5% marrow blasts by morphology in the context of hematological recovery (ANC ≥ 0.5× 10\\^9\u002FL, platelet count ≥ 50 × 10\\^9\u002FL).\n   2. Morphological leukemia free state (MLFS) defined by the absence of hematological recovery and \\\u003C 5% marrow blasts by morphology\n2. Patients must further meet one of the below for inclusion into the study:\n\n   1. De novo AML in CR1 with any of the following high-risk features:\n\n      * MRD ≥ 1% after first induction course\n      * MRD ≥ 0.1% after second induction course\n      * RPN1-MECOM\n      * RUNX1-MECOM\n      * NPM1-MLF1\n      * DEK-NUP214\n      * KAT6A-CREBBP (if ≥ 90 days at diagnosis)\n      * FUS-ERG\n      * KMT2A-AFF1\n      * KMT2A-AFDN\n      * KMT2A-ABI1\n      * KMT2A-MLLT1\n      * 11p15 rearrangement (NUP98 - any partner gene)\n      * 12p13.2 rearrangement (ETV6 - any partner gene)\n      * Deletion 12p to include 12p13.2 (loss of ETV6)\n      * Monosomy 5\u002FDel(5q) to include 5q31 (loss of EGR1)\n      * Monosomy 7\n      * 10p12.3 rearrangement (MLLT10b - any partner gene)\n      * FLT3\u002FITD with allelic ratio \\> 0.1%, without bZIP CEBPA or NPM1\n      * RAM phenotype as evidenced by flow cytometry\n      * Other high-risk features not explicitly stated here, after discussion\u002Fapproval with protocol PI.\n   2. De novo AML in ≥ CR2\n   3. Therapy-related AML in CR1\n   4. AML evolving from myelodysplastic syndrome (MDS)\n3. One prior hematopoietic cell transplant is allowed, provided remission criteria as defined above are met.\n\nPatient Inclusion Criteria - Cohort 2:\n\n1. High risk acute myeloid leukemia (AML) defined by either of the following:\n\n   1. Treatment refractory disease: AML that is not in complete remission despite prior standard or salvage therapies.\n   2. Multiply relapsed disease: AML that has relapsed after 2 or more hematopoietic cell transplantations.\n2. BM disease burden: Less than 25% bone marrow blasts by morphology must be present (M2 marrow), irrespective of peripheral hematological recovery.\n\nPatient Inclusion Criteria - Both Cohorts:\n\n1. Less than or equal to 40 years of age.\n2. Lansky (\\\u003C16 years) or Karnofsky (≥16 years) performance status of \\>60%.\n3. Adequate organ function as defined below:\n\n   1. Total bilirubin ≤ 3 x IULN for age\n   2. AST(SGOT)\u002FALT(SGPT) ≤ 5 x IULN for age\n   3. GFR ≥ 60 mL\u002Fmin\u002F1.73m2 as estimated by (1) updated Schwartz formula for ages 1-17 years or Cockcroft-Gault formula for ages ≥ 18 years, (2) 24-hour creatinine clearance, or (3) renal scintigraphy. If GFR is abnormal for age based on updated Schwartz or Cockcroft-Gault formula, accurate measurement should be obtained by either 24-hour creatinine clearance or renal scintigraphy.\n   4. Renal function may also be estimated by serum creatinine based on age\u002Fgender. A serum creatinine \\\u003C 2 x IULN for age\u002Fgender is required for inclusion on this protocol.\n4. Adequate cardiac function, defined by left ventricular ejection fraction (LVEF) at rest ≥50% or shortening fraction (SF) ≥27% (via echocardiogram or MUGA).\n5. Adequate pulmonary function, defined by:\n\n   1. FEV1, FVC, and DLCO ≥50% of predicted.\n   2. O2 saturation ≥ 92% on room air by pulse oximetry and no supplemental O2 at rest for children \\\u003C 8 years of age or those unable to perform pulmonary function testing (PFT). For children unable to perform PFT, a high-resolution CT chest should be obtained.\n6. The effects of these treatments on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation, and for 24 months following transplant. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.\n7. Ability to understand and willingness to sign an IRB approved written informed consent document, or patient has a guardian who has the ability to understand and willingness to sign an IRB approved written informed consent document.\n8. Available familial haploidentical donor. The HCT donor must be available and willing to undergo 2 leukapheresis procedures: (I) one mobilized collection for the HPC graft and (II) one non-mobilized leukapheresis collection for the manufacturing of ML NK cells.\n9. Donor and recipient must be identical at a minimum of one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA- DQB1. A minimum of 5\u002F10 match is required and will be considered sufficient evidence that the donor and recipient share one HLA haplotype.\n\nPatient Exclusion Criteria - Both Cohorts\n\n1. Active GvHD. If patient had prior GvHD, patient must be off immunosuppression for at least 3 months prior to starting study treatment.\n2. Active non-hematologic malignancy. History of other malignancy is acceptable as long as therapy has been completed and there is no current evidence of disease.\n3. Currently receiving any other investigational agents at the time of transplant.\n4. Active CNS or extramedullary disease. History of CNS or extramedullary disease currently in remission is acceptable.\n5. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.\n6. Inability to discontinue medications that are likely to interfere with ML NK cell activity, i.e., glucocorticoids and other immunosuppressants.\n7. Presence of significant anti-donor HLA antibodies per institutional standards. Anti-donor HLA - Antibody Testing is defined as a positive crossmatch test of any titer (by complement dependent cytotoxicity or flow cytometric testing) or the mean fluorescence intensity (MFI) of any anti-donor HLA antibody by solid phase immunoassay \\> 3000.\n8. Presence of a second major disorder deemed a contraindication for HCT.\n9. Patients with Fanconi Anemia or Down Syndrome.\n10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (bacterial, viral with clinical instability, or fungal), symptomatic congestive heart failure, or unstable cardiac arrhythmia.\n11. Pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 14 days of the start of conditioning.\n\nDonor Eligibility Criteria - Both Cohorts\n\n1. The preferred donor should be an adult aged 18 years or older. However, in circumstances where no suitable adult donor is available, consideration may be given to a minor donor aged 12 years or older. This exception only applies when all identified, otherwise eligible adult donors meet one or more of the following criteria:\n\n   * A medical condition that poses unacceptable risk, including autoimmune disease, infection, hematologic disorder, malignancy or a pathogenic germline mutation.\n   * Comorbidities that preclude safe administration of granulocyte colony-stimulating factor (G-CSF), placement of a pheresis catheter and\u002For stem cell collection.\n   * Served as donor in prior haploidentical HCT.\n   * Significant psychosocial or logistical barriers.\n2. Donor must be HLA haploidentical (≥ 5\u002F10 and ≤ 9\u002F10 allele match at the -A, -B, -C, DRB1 and DQ loci) by high resolution typing and related to the patient.\n3. Donor must meet the selection criteria as defined by the Foundation for the Accreditation of Hematopoietic Cell Therapy (FACT).\n4. Donor must be available and willing to undergo one mobilized and one non-mobilized leukapheresis procedure.\n5. Donor may not be pregnant and\u002For breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days prior to initiation of recipient's conditioning regimen, within 7 days of donor stem cell mobilization regimen and prior to second non-mobilized leukapheresis..\n6. Donor must be able to understand and willing to sign an IRB-approved written informed consent document.",{"count":567,"type":23},68,[26,180],"This trial represents a single institution phase I\u002FII pilot study with the primary objective of establishing the safety and feasibility of generating and infusing ML NK cells after TCRαβ haplo-HCT.",[571,572,573,30],"AML, Childhood","Aml","Acute Myeloid Leukemia, Pediatric",[575,576,577,578,579,580],"high-risk AML","haploidentical transplant","high-risk acute myeloid leukemia","AML from MDS","memory-like natural killer cells","ML NK cells","2026-04-29",{"date":583,"type":38},"2026-05-05",{"date":585,"type":38},"2024-11-15",{"date":587,"type":23},"2030-05-31",{"name":589,"class":102},"Washington University School of Medicine",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":596,"eligibilityCriteria":597,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":24,"phases":600,"briefSummary":601,"conditions":602,"keywords":603,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":103},"100437507","phase-2-cardioprotection-in-aml-100437507","NCT04977180","Cardioprotection in AML","Phase II Trial of Cardioprotective Prophylaxis With Combination of Beta Blocker and Angiotensin-Converting Enzyme Inhibitors During Intensive Chemotherapy for Patients With Newly Diagnosed Acute Myeloid Leukemia","AML 001","Inclusion Criteria:\n\n1. Signed informed consent obtained prior to conducting any study-specific screening procedures.\n2. Willing and able to understand the nature of this study and to comply with both the study as well as follow-up procedures for the duration of the study.\n3. Age ≥ 18 years old with newly-diagnosed Acute Myeloid Leukemia (AML)\n4. ECOG performance status must be ≤ 2\n5. Planning to receive initial induction therapy containing an anthracycline for AML. Participants may have started initial induction therapy if anthracycline has not yet been administered.\n6. Adequate organ function as evidenced by the following laboratory findings:\n\n   1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or \\\u003C 3 x ULN for patients with Gilbert's Syndrome\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n   3. Creatinine clearance \\> 60 mL\u002Fmin\n7. Ability to take oral medication and a willingness to adhere to the beta blocker and lisinopril regimen\n8. Echocardiogram demonstrating an ejection fraction ≥ 50% prior to the initiation of induction chemotherapy\n9. For females of reproductive potential and males: Agree to abstain from sexual activity or use reliable contraception while undergoing treatment with chemotherapy and\u002For ACE inhibitors due to the risk of teratogenicity to the fetus.\n\nExclusion Criteria:\n\n1. Ongoing use of any beta blocker, ACEi, or angiotensin II receptor agonist (ARB) at the time of pre-enrollment screening.\n2. Uncontrolled, intercurrent illnesses including but not limited to symptomatic unstable angina pectoris, cardiac arrhythmias not well controlled with medications, myocardial infarction in the 6 months preceding registration or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements as determined by the study personnel, all at the discretion of the treating oncologist.\n3. Patient receiving concurrent investigational agents, or those who have received an investigational agent within one week of registration.\n\nException - Participants may receive concurrent investigational agents, or have done so within one week of registration if:\n\n* The side effects of the drug are well studied and well known AND\n* The drug is not known to be cardioprotective or cardiotoxic\n\n  4\\. Females who are pregnant or lactating.\n\n  5\\. Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or study outcomes.\n\n  6\\. Active, untreated and\u002For severe infections as determined by the treating oncologist.\n\n  7\\. History of hematopoietic stem cell transplant (HSCT) with active graft vs host disease, immunosuppression other than low-dose prednisone (≤ 5mg) or calcineurin inhibitors within the four weeks preceding registration\n\n  8 Moderate or severe mitral or aortic valve disease, as determined by echocardiography\n\n  9\\. Congestive heart failure as clinically diagnosed by treating oncologist at the time of presentation for induction chemotherapy, or documented diagnosed by a previous physician.\n\n  10\\. History of (repaired or unrepaired) congenital heart disease that precludes recommendation for or administration of additional anthracyclines\n\n  11\\. Significant liver disease, including cirrhosis or history of transplant or hepatorenal syndrome)\n\n  12\\. Bradycardia (defined as baseline resting heart rate ≤ 60 beats per minute) or third degree atrioventricular heart block at presentation for induction chemotherapy.\n\n  13\\. Baseline resting systolic blood pressure \\\u003C 95mmHg at presentation for induction chemotherapy.\n\n  14\\. Documented allergy to beta blockers or ACE inhibitors.",{"count":599,"type":23},70,[180],"Patients with acute myeloid leukemia (AML) often receive a drug called daunorubicin. Daunorubicin is a type of drug called an anthracycline, which increases the risk of some damage to the heart. Beta blockers and angiotensin-converting enzyme inhibitors (ACEi) are two types of drugs that are often used (and are FDA approved) to treat the type of damage to the heart caused by anthracyclines. They have also been used in some populations to prevent this type of heart damage. In this study, participants will be randomly assigned to either preventively take a beta blocker and ACEi or not to receive these. The primary purpose of the study is to look at how often people in each group develop this type of heart damage. The study investigators will also collect data about your quality of life and other changes in your heart function.\n\nFrequency and severity of anthracycline-induced cardiotoxicity among patients receiving acute myeloid leukemia (AML) chemotherapy is unknown. We hypothesize that up-titrating study agents to maximum tolerated dosage at the time of induction (starting treatment for AML) will prevent the development of systolic dysfunction as determined on serial echocardiography.",[29,30],[604],"cardioprotection","2026-04-28",{"date":583,"type":38},{"date":608,"type":38},"2022-03-04",{"date":610,"type":23},"2028-09",{"name":612,"class":102},"University of Virginia",{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":4,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":85,"maxAge":474,"enrollmentInfo":620,"targetDuration":4,"studyType":24,"phases":622,"briefSummary":623,"conditions":624,"keywords":4,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":626,"startDateStruct":628,"completionDateStruct":629,"leadSponsor":631,"locationsCount":4},"100634448","phase-3-azacitidine--venetoclax-vs-azacitidineas-maintenance-therapy-in-aml-100634448","NCT07539818","Azacitidine + Venetoclax VS Azacitidineas Maintenance Therapy in AML","A Study of Azacitidine With or Without Venetoclax as Maintenance Therapy in Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of AML per WHO 2022 or ICC criteria, or MDS\u002FAML (10-20% blasts) per ICC\n* Age ≥14 and \\\u003C75 years\n* ECOG performance status 0-2\n* First complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation\n* Received at least 2 cycles of intermediate- or high-dose cytarabine (cumulative dose ≥6 g\u002Fm² per cycle)\n* Time from first CR\u002FCRi to enrollment ≤10 months, and time from last treatment to enrollment ≤3 months\n* MRD-negative or low-level MRD detectable; MRD-positive patients are excluded\n* Signed informed consent\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML-RARA\n* AML with BCR-ABL\n* Active central nervous system involvement\n* Prior allogeneic hematopoietic stem cell transplantation\n* Planned allogeneic HSCT within 6 months\n* Deemed unsuitable by investigator",{"count":621,"type":23},788,[115],"This is a prospective, multicenter, randomized, open-label, phase III trial evaluating the efficacy and safety of azacitidine plus venetoclax versus azacitidine alone as maintenance therapy in patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR) or CR with incomplete count recovery (CRi) after induction and consolidation. Eligible patients aged 14 to 74 years are randomized 1:1 to receive either azacitidine 50 mg\u002Fm²\u002Fday on days 1-5 every 6 weeks for up to 12 cycles, or the same azacitidine regimen combined with venetoclax 400 mg on days 1-7 per cycle. The primary endpoint is disease-free survival (DFS). Secondary endpoints include overall survival (OS), relapse-free survival (RFS), cumulative incidence of relapse (CIR), minimal residual disease (MRD) conversion rate, and safety. A total of 788 patients are planned with stratification by prior venetoclax exposure and MRD status.",[29],"2026-04-13",{"date":627,"type":38},"2026-04-20",{"date":581,"type":23},{"date":630,"type":23},"2031-04-01",{"name":101,"class":102},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":269,"maxAge":474,"enrollmentInfo":638,"targetDuration":4,"studyType":24,"phases":640,"briefSummary":641,"conditions":642,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":625,"lastUpdatePostDateStruct":644,"startDateStruct":646,"completionDateStruct":648,"leadSponsor":650,"locationsCount":103},"100630889","phase-2-mt2025-35-allogeneic-hematopoietic-stem-cell-transplantation-using-reduced-intensity-conditioning-treosulfan-and-fludarabine-with-post-transplant-cytoxan-ptcy-for-the-treatment-of-hematological-diseases-100630889","NCT07493538","MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Patients 2-75 years of age\n* ≤7 5 years of age: Karnofsky score ≥ 70% (≥ 16 years) or Lansky play score ≥ 50 (\\\u003C 16 years) with appropriate organ criteria as below (in other inclusion criteria)\n* 5\u002F6 or 6\u002F6 related donor, OR a 5-8\u002F8 HLA-A, B, C, DRB1 allele match unrelated donor, OR a haplotype (at least 5\u002F10) related donor\n* adequate liver (no decompensated liver failure, Child Pugh A, AST\u002FALT \\\u003C5X ULN) and renal function (creatinine \\\u003C2.0)\n* absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 40%\n* DLCO FEV1, FVC ≥ 40% predicted, and absence of O2 requirement\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Evidence of untreated\u002Funcontrolled HIV infection\n* Untreated active serious infection\n* Active CNS malignancy\n* CML in blast crisis not in a complete remission by abnormal blast count.\n* Less than 3 months since prior myeloablative transplant",{"count":639,"type":23},132,[180],"This is a Phase II study following subjects proceeding with Treosulfan (36g\u002Fm2) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion, with post-transplant cyclophosphamide (PTCy) at 40mg\u002Fkg, tacrolimus and MMF for GVHD prophylaxis.",[29,208,67,30,643],"Myelodysplastic Syndromes",{"date":645,"type":38},"2026-04-16",{"date":647,"type":38},"2026-04-10",{"date":649,"type":23},"2035-03",{"name":651,"class":102},"Masonic Cancer Center, University of Minnesota",{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":4,"eligibilityCriteria":658,"healthyVolunteers":12,"sex":18,"minAge":659,"maxAge":474,"enrollmentInfo":660,"targetDuration":4,"studyType":24,"phases":662,"briefSummary":663,"conditions":664,"keywords":667,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":670,"lastUpdatePostDateStruct":671,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":103},"100519771","phase-1-uab-2419-cd34-selection-using-the-automated-clinimacs-prodigy-100519771","NCT06047886","UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy","Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS","Inclusion Criteria:\n\n1. AML in morphologic remission with intermediate\u002Fhigh-risk features or relapsed disease 1 or 2\n2. ALL in morphologic remission with high-risk features or relapsed disease 1 or 2\n3. Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)\n4. Myelodysplastic syndromes with \\\u003C=10% blasts\n5. CML in morphologic remission after blast phase or accelerated phase\n6. Primary myelofibrosis with \\\u003C=10% blasts \\^morphologic remission is defined as \\\u003C5% blasts on the bone marrow biopsy. Negative test for donor-specific antibody within 28 days of starting conditioning regimen, or adequate for standard desensitization protocol.\n\nExclusion Criteria:\n\n1. Non-compliant patients.\n2. No appropriate caregivers identified.\n3. Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).\n4. Patients with known allergy to DMSO.\n5. Pregnant or breastfeeding women","4 Weeks",{"count":661,"type":23},50,[26],"Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.",[29,18,665,643,402,666],"Lymphoid Malignancies","Primary Myelofibrosis",[668,669],"hematologic malignancies","graft failure","2026-04-08",{"date":625,"type":38},{"date":673,"type":38},"2025-04-22",{"date":675,"type":23},"2029-12",{"name":677,"class":102},"University of Alabama at Birmingham",{"id":679,"slug":680,"hasResults":12,"nctId":681,"briefTitle":682,"officialTitle":682,"acronym":4,"eligibilityCriteria":683,"healthyVolunteers":12,"sex":18,"minAge":684,"maxAge":685,"enrollmentInfo":686,"targetDuration":4,"studyType":24,"phases":688,"briefSummary":689,"conditions":690,"keywords":696,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":704,"completionDateStruct":705,"leadSponsor":707,"locationsCount":103},"100632643","mynavigate-a-guide-to-after-treatment-effects-for-adolescents-and-young-adults-100632643","NCT07516353","my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults","Inclusion Criteria:\n\n* Patients aged 15-24 who are currently undergoing cancer treatment at one of the three participating sites: DFCI, CNH, or RPOCH.\n* Patients must have initiated and be actively receiving cancer directed therapy for a newly diagnosed cancer.\n* Patients must be actively receiving cancer directed therapy, between the time of diagnosis and end of therapy for the following diagnoses: 1) Sarcomas: including osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma; 2) Acute Myeloid Leukemia (AML); 3) Acute Lymphoblastic Leukemia\u002FLymphoma (ALL); 4) Hodgkin and mature B-cell Lymphomas; and 5) Medulloblastoma.\n* Patients whose treatment includes alkylators, anthracyclines, and\u002For radiation.\n\nInclusion of Children:\n\n• This study is designed to keep AYAs aged 15-24 engaged in cancer survivorship care and therefore a subset of participants will be \\\u003C18 years of age. The rationale for inclusion of children in this study is that AYA cancer survivors are particularly vulnerable to loss to follow-up and consequently lack of risk-based survivorship care, resulting in increased risk for preventable toxicity. Many existing interventions to improve engagement in survivorship screening and care are introduced after treatment completion and in long-term survivorship. Yet, for patients who are unaware of their late effect risks, and\u002For those who move frequently and are lost to follow-up, this may be too late. This study is designed to improve awareness of and engagement in risk-informed survivorship care for AYAs. This study presents no more than minimal risk to participants.\n\nExclusion Criteria:\n\n* Patients who are unwilling to give informed consent or assent to participate will be excluded. For patients under 18, patients whose guardians do not give informed consent will be excluded.\n* Patients with no chance of cure as identified by the AYA's physician, will be excluded given that issues of survivorship are not relevant and may be distressing to this population. Similarly, patients with relapsed or refractory disease will also be excluded.\n* Patients who are non-English-speaking and -reading will be excluded as the digital tool is being developed initially in English.\n* We will seek physician permission before offering enrollment to patients. If the provider team requests that the patient not be approached to participate, the patient will be excluded.","15 Years","24 Years",{"count":687,"type":23},143,[90],"This study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. my.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).",[691,692,693,363,30,572,18,694,695],"Sarcoma","Osteosarcoma","Ewing Sarcoma","Medulloblastoma","Acute Lymphoblastic Leukemia ,Lymphomas",[697,698,699,700,701,691,692,693,363,30,572,18,694],"Cancer Survivorship","Adolescent and Young Adult Cancer","Late Effects of Cancer Treatment","Hodgkin and mature B-cell Lymphomas","Acute Lymphoblastic Leukemia\u002FLymphoma","2026-03-31",{"date":670,"type":38},{"date":35,"type":23},{"date":706,"type":23},"2030-12-31",{"name":708,"class":102},"Dana-Farber Cancer Institute"]