[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukaemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,50,76,102,129,157,189,216],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100604877","phase-1-study-of-azd3632-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-advanced-haematologic-malignancies-with-kmt2ar-npm1m-or-other-genotypes-associated-with-hox-overexpression-100604877",false,"NCT07155226","Study of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression","A Modular Phase I\u002FII, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants With Advanced Haematologic Malignancies With KMT2Ar, NPM1m, or Other Genotypes Associated With HOX Overexpression","MOMENTUM","Key Inclusion Criteria:\n\nCore criteria:\n\n* Adequate organ function.\n* Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nModule 1:\n\n* Advanced haematologic malignancy - a) for dose escalation - diagnosis of acute leukemia or myelodysplastic neoplasia (MDS) and harbouring one of the genetic alterations per local testing associated with upregulation of HOX; b) for Backfill - diagnosis of harbouring a KMT2Ar or NPM1m per local testing.\n* Participants must have measurable disease that is relapsed\u002Frefractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory acute leukaemia after standard of care therapy including but not limited to 2 cycles of intensive chemotherapy, hypomethylating agent (HMA) monotherapy, or HMA combinations such as HMA\u002Fvenetoclax.; b) Relapsed and primary refractory MDS is defined by ≥ 5% blasts in the bone marrow and\u002For persistence of peripheral blasts after treatment with at least 2 cycles of HMA. Participants ineligible for the treatment with an HMA and without any other standard of care (SoC) options are allowed to enrol; c) White blood cell count below 25,000\u002FμL. Participants may receive cytoreduction per protocol-specified criteria; d) Performance status: Eastern Cooperative Operative Group (ECOG) ≤ 2; e) Life expectancy: ≥ 8 weeks.\n\nModule 2:\n\n* Participants must have measurable disease that is relapsed\u002Frefractory to conventional therapies known to be effective for their disease and not have any available approved therapies.: a) Relapsed and primary refractory acute leukaemia after standard of care therapy including but not limited to 2 cycles of intensive chemotherapy, HMA monotherapy, or HMA combinations such as HMA\u002Fvenetoclax.; b) Relapsed and primary refractory MDS is defined by ≥ 5% blasts in the bone marrow and\u002For persistence of peripheral blasts after treatment with at least 2 cycles of HMA. Participants ineligible for the treatment with an HMA and without any other SoC options are allowed to enrol; c) White blood cell count below 25,000\u002FμL. Participants may receive cytoreduction per protocol-specified criteria; d) Performance status: ECOG ≤ 2; e) Life expectancy: ≥ 8 weeks.\n\nKey Exclusion Criteria:\n\nCore criteria:\n\n* Participants with Burkitt lymphoma\u002Fleukaemia or Acute Promyelocytic Leukaemia.\n* Active testicular or active central nervous system (CNS) (\\> CNS1 or radiographic) involvement by leukaemia.\n* Unresolved treatment-related toxicities Grade ≥ 2 from prior therapy.\n* Abnormal levels of potassium or magnesium prior to first dose of AZD3632.\n\nModule 1:\n\n* Receipt of non-CNS radiation therapy within 2 weeks and of CNS radiation within 8 weeks of the first scheduled dose.\n* Receipt of any investigational or non-investigational anticancer agents, including non-biologic agents, biologic agents and\u002For prior treatment other menin inhibitors (backfill participants only).\n* For nested food effect participants - diagnosis of diabetes mellitus (Type I or Type II).\n\nModule 2:\n\n* Receipt of any non-investigational anticancer agents, including non-biologic agents and\u002For biologic agents or receipt of non-CNS or CNS radiation therapy.\n* Participants for whom treatment with posaconazole is contraindicated per the local prescribing information.","ALL","16 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The purpose of this study is to understand the safety, tolerability, efficacy, pharmacokinetic (PK), pharmacodynamic (PD), and preliminary efficacy of orally administered AZD3632 in participants with advanced haematologic malignancies with KMT2Ar, NPM1m, or other genotypes associated with homeobox (HOX) overexpression.",[28,29,30],"Acute Lymphoblastic Leukaemia","Acute Myeloid Leukaemia","Higher-risk Myelodysplastic Syndromes",[32,33,34,35,36],"Myelodysplastic Syndromes","Menin inhibitor","Anti-leukaemic activity","Anti-fungal agent","HOX overexpression.","RECRUITING","2026-06-16",{"date":40,"type":41},"2026-06-17","ACTUAL",{"date":43,"type":41},"2026-01-09",{"date":45,"type":21},"2029-02-15",{"name":47,"class":48},"AstraZeneca","INDUSTRY",30,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100640433","phase-2-a-study-to-assess-how-well-the-study-medicine-ipn60340-works-in-combination-with-azacitidine-and-venetoclax-compared-to-placebo-in-combination-with-azacitidine-and-venetoclax-in-participants-with-newly-diagnosed-acute-myeloid-leukemia-who-cannot-receive-intensive-chemotherapy-100640433","NCT07623187","A Study to Assess How Well the Study Medicine IPN60340 Works in Combination With Azacitidine and Venetoclax, Compared to Placebo in Combination With Azacitidine and Venetoclax, in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Cannot Receive Intensive Chemotherapy","A Two-part, Phase 2b\u002FPhase 3 Double-blinded, Randomized Study of IPN60340 in Combination With Azacitidine and Venetoclax Versus Placebo in Combination With Azacitidine and Venetoclax in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy.","EVICTION 3","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older, at the time of signing the informed consent.\n2. Have newly diagnosed AML, as per WHO 2022 criteria.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 1 to 2 for participants ≥75 years of age, or 1 to 3 for participants \\\u003C75 years of age\n4. Participants must be considered ineligible for intensive chemotherapy, due to age or comorbidities,\n5. Adequate organ function as indicated in the protocol\n6. Contraceptive use by participant or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.\n7. Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Current diagnosis of:\n\n   I. Acute promyelocytic leukemia (APL) II. Active or uncontrolled central nervous system (CNS) leukemia III. Any γ9δ2TC neoplasm\n2. History of myeloproliferative neoplasms (MPN) including primary myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia, or MDS\u002FMPN as per WHO 2022 or treatment-related AML\n3. History of other malignancy within the last 2 years.\n4. Rapidly progressing disease in the opinion of the clinical investigator which may preclude treatment in this study.\n5. History of clinically significant or uncontrolled cardiac disorders, within 6 months prior to Cycle 1 Day 1 (C1D1)\n6. White blood cell (WBC) count \\>25 × 10\\^9\u002FL . Cytoreduction can be used before C1D1 and beyond as needed to keep WBC \\\u003C 25 × 10\\^9.\n7. Participants with severe hepatic impairment, e.g., Child-Pugh C, are excluded.\n8. Major surgery within 4 weeks prior to C1D1 or planned during the foreseeable duration of the study.\n9. Any gastrointestinal disorder or malabsorption syndrome that may impair absorption of venetoclax\n10. Uncontrolled or severe bacterial, fungal, viral, and\u002For parasitic infections treated with therapeutic oral or intravenous anti-infective agents. Prophylactic antimicrobials are allowed.\n11. Uncontrolled human immunodeficiency virus (HIV) disease will be excluded. Participants on anti-retroviral therapy should be included as long as their disease is under control, taking precautions to modify their highly active antiretroviral therapy (HAART) regimen to minimize drug interactions.\n12. Presence of hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) at screening or within 3 months prior to randomization.\n\n    NOTE: Participants with known positive HBsAb may be randomized provided they are hepatitis B-vaccinated and have negative HBsAg and HBcAb.\n13. Positive hepatitis C antibody test result at screening or within 3 months of randomization unless HCV-RNA negative test is documented.\n\n    NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled if a confirmatory negative hepatitis C ribonucleic acid (RNA) test is obtained.\n14. Participant has received strong and\u002For moderate cytochrome P450 (CYP)3A inducers within 7 days prior to the initiation of study treatment.\n15. Participant is unable to swallow capsules or tablets\n16. Prior treatment with hypomethylating agents, chemotherapy, B-cell lymphoma protein (BCL) 2 inhibitors, clinical trial therapy, cellular therapy or allogenic hematopoietic cell transplantation (HCT) for MDS.\n17. Treatment with systemic corticosteroids of \\>10 mg\u002Fday prednisone (or equivalent) or other systemic immunosuppressive medications within 5 half-lives prior to C1D1, or anticipated requirement for systemic immunosuppressive medications during the study.\n18. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator \\[or medical monitor\\], contraindicates participation in the study.","18 Years",{"count":60,"type":21},450,[25,62],"PHASE3","The purpose of this study is to find out how well the study drug IPN60340 works to treat participants with acute myeloid leukemia. Acute myeloid leukemia is a rare blood cancer that grows quickly. This study's main aim is to compare the percentage of participants who reach complete remission within the first 6 months of treatment between the 2 study arms (study drug and standard medicines compared to placebo and standard medicines).\n\nIn this study all participants will receive azacitidine and venetoclax plus either the study drug IPN60340 or placebo. Venetoclax will be given as a tablet by mouth once each day in 28-day cycles. Azacitidine will be given by injection under the skin (subcutaneously) or through the veins (intravenously) daily for the first 7 days of each 28-day cycle. IPN60340 or placebo (depending on which arm of the study the participant is assigned to) will be given through the veins (intravenously) on day 1 of each 28-day cycle.\n\nThere will be 4 periods in this study:\n\n* A screening period (up to 28 days) to assess whether the participant can take part requiring at least 1 visit to the study center.\n* A treatment period where all eligible participants will receive azacitidine and venetoclax plus either the study drug IPN60340 or placebo. The study requires 8 visits for the first month followed by 1 visit every month until unacceptable toxicity, disease progression, the start of new cancer treatment, or study closure, whichever is first.\n* A safety follow-up period (at 28 days (±3 days) after the last dose of study medicine) to assess safety after participants have finished treatment.\n* A long-term follow-up period where participants' health will be monitored using a telephone call or clinic visit every 12 weeks until the end of study.\n\nParticipants will undergo blood sampling, urine collections, physical examinations, clinical evaluations, electrocardiograms (ECG: recording of the electrical activity of heart), bone marrow aspirates (sampling of the liquid part of the bone marrow). Some participants will also undergo pregnancy testing. Participants in the Phase 3 portion of the study will also be asked to fill in questionnaires.\n\nThe time each participant will be in this study will vary based on how well the medicine works to treat the participant's AML. Azacitidine and venetoclax plus either IPN60340 or placebo will be provided to participants who tolerate it for as long as their disease does not progress. Participants may withdraw consent to participate at any time.",[65,29],"Acute Myeloid Leukaemia (AML)","NOT_YET_RECRUITING","2026-05-29",{"date":69,"type":41},"2026-06-03",{"date":71,"type":21},"2026-11-01",{"date":73,"type":21},"2032-05-31",{"name":75,"class":48},"Ipsen",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":58,"enrollmentInfo":84,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100587478","leukemia-adapted-protocol-100587478","NCT06928909","Leukemia Adapted Protocol","Evaluating the Feasibility of an Intensity-Adapted Pediatric Acute Myeloid Leukemia Treatment Guideline in Malawi","LEAP","Inclusion Criteria:\n\n1. Age Patients must be \\\u003C18 years of age at time of study enrollment.\n2. Diagnosis\n\n   Patients must be diagnosed with de novo AML according to 2022 WHO 5th Edition classification with or without extramedullary disease. Patients must have one of the following:\n   * Bone marrow myeloblasts ≥20%. In cases of dry taps due to fibrosis, myeloblast percentage can be estimated from a bone marrow biopsy core specimen. Due to unavailable molecular\u002Fcytogenetic diagnostics in Malawi, patients with \\\u003C20% bone marrow myeloblasts can be included in the study at the discretion of the treating oncologist with rationale documented.\n   * In cases where a bone marrow evaluation is not safe\u002Ffeasible, a peripheral blood sample may be used with a documented absolute myeloblast percentage of ≥1000\u002FμL calculated based on a total white blood cell count and percentage circulating blasts.\n3. Therapy Patients must begin treatment according to the 2023 KCH AML therapy CPG.\n\nExclusion Criteria:\n\n1. Patients with any of the following conditions or criteria will be excluded from the study:\n\n   * Juvenile myelomonocytic leukemia\n   * Transient myeloproliferative disorder\n   * Acute promyelocytic leukemia\n   * Mixed phenotype acute leukemia\n   * Trisomy 21\n   * Current pregnancy\n   * Previous or concurrent malignancy\n   * Isolated myeloid sarcoma\n2. Patients previously treated with antineoplastic therapy with the following exceptions:\n\n   * Hydroxyurea\n   * Corticosteroids\n   * Intrathecal chemotherapy at diagnosis",{"count":49,"type":21},"OBSERVATIONAL","In resource-constrained settings such as Malawi, survival rates for pediatric acute myeloid leukemia (AML) are dismally low compared to high-resource environments. This disparity highlights the urgent need for feasible treatment protocols tailored to the realities of these regions where most children with cancer are treated. In 2023, after reviewing favorable clinical trials results in other resource-limited settings, the Kamuzu Central Hospital (KCH) pediatric cancer unit adopted an evidence-based intensity-adapted clinical practice guideline (CPG) developed by the International Society of Paediatric Oncology (SIOP) as its standard of care for the treatment of pediatric AML, aiming to balance curative intent with manageable toxicity. The current study is a prospective evaluation of outcomes of standard of care in Malawi using the SIOP CPG in a real-world setting.\n\nThe LEAP study aims to assess the implementation of the SIOP AML guidelines at KCH in an effort to continually improve outcomes in Malawi. The study is an observational-implementation design with a composite effectiveness-implementation outcome called Implementation Success. Implementation Success combines feasibility, the ability of patients to complete all aspects of the CPG, with effectiveness, the ability to maintain historical rates of complete remission of 40% at the treatment center.\n\nThis prospective cohort study will enroll children under 18 years diagnosed with de novo AML at KCH. Implementation Success will be the primary endpoint, with secondary endpoints including CPG fidelity, long-term survival, adverse events, and hematologic recovery times. Patient-reported outcomes will also be collected to assess the impact of treatment on quality of life.\n\nThis will be the first prospective study of pediatric AML in sub-Saharan Africa, providing critical data on the management of AML in low-resource settings. By assessing the implementation of a context-adapted CPG, the study will contribute to the global effort to improve pediatric AML outcomes in resource-constrained environments. The findings will serve to guide practitioners in Malawi and similar settings, and the data generated will be invaluable for future clinical decisions and CPG development.",[29],[89,90],"Pediatric Acute Myeloid Treatment","Acute myeloid leukemia (AML)","2026-03-31",{"date":93,"type":41},"2026-04-06",{"date":95,"type":41},"2025-01-01",{"date":97,"type":21},"2030-12-31",{"name":99,"class":100},"Baylor College of Medicine","OTHER",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":101},"100595730","phase-1-clinical-study-of-u32-in-patients-with-acute-myeloid-leukemia-100595730","NCT07036250","Clinical Study of U32 in Patients With Acute Myeloid Leukemia","A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of U32 Injection in Patients With Acute Myeloid Leukemia.","Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form and be expected to complete the follow-up examinations and treatments as required by the study protocol.\n2. Be aged ≥2 years and ≤65 years at the time of signing the informed consent form, with no restrictions on gender.\n3. Meet the AML diagnosis according to the 2022 WHO classification and satisfy the diagnostic criteria for relapsed and refractory acute myeloid leukemia as defined in the \"Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (2023 Edition)\": a) Relapsed AML diagnostic criteria: reappearance of leukemia cells in peripheral blood after complete remission (CR), or positivity for minimal residual disease (MRD) detected by flow cytometry in bone marrow (excluding other causes such as bone marrow regeneration after consolidation chemotherapy), or extramedullary infiltration of leukemia cells. b) Refractory AML diagnostic criteria: newly diagnosed cases that are ineffective after two courses of standard treatment; relapse within 12 months after CR and subsequent consolidation therapy; relapse after 12 months that is ineffective to conventional chemotherapy; cases with two or more relapses; persistent extramedullary leukemia.\n4. AML patients who are molecularly positive after treatment and cannot achieve negativity through conventional therapy.\n5. Positive expression of CD38 or CLL-1 confirmed by immunohistochemistry or flow cytometry.\n6. Have previously received at least two lines of adequate treatment or allogeneic hematopoietic stem cell transplantation (HSCT).\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 3, with an expected survival of more than 3 months.\n8. Have adequate bone marrow reserve at screening, defined as: absolute lymphocyte count (ALC) ≥0.3×10\\^9\u002FL, platelets (PLT) ≥20×10\\^9\u002FL (including with platelet transfusion support).\n9. Have appropriate organ function: aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3 times ULN; total bilirubin ≤1.5 times ULN; serum creatinine ≤1.5 times ULN, or creatinine clearance rate ≥60 mL\u002Fmin; hemoglobin ≥60 g\u002FL or maintained at this level after transfusion; peripheral capillary oxygen saturation ≥92%; left ventricular ejection fraction (LVEF) ≥45%.\n10. Female subjects must meet the following criteria to be considered for enrollment: a) Be of non-childbearing potential, defined as: having undergone hysterectomy or bilateral oophorectomy, or having had bilateral tubal ligation, or being postmenopausal (complete cessation of menstruation for ≥1 year); b) Be of childbearing potential, but have a negative serum pregnancy test at screening, and agree to use medically accepted contraceptive measures (such as intrauterine device, oral contraceptives, or condoms) before enrollment and during the study, until 1 year after the last study drug administration.\n11. Male subjects of childbearing potential must agree to use barrier contraception or complete abstinence until 1 year after the last study drug administration.\n12. Have sufficient venous access for apheresis or intravenous blood draw, and no contraindications for leukapheresis.\n13. For subjects who have received daratumumab or other CD38 - targeted therapies, the washout period for CD38 monoclonal antibody should be at least 3 months before the reinfusion treatment.\n\nExclusion Criteria:\n\n1. Having other malignancies within 3 years prior to screening, with the exception of adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.\n2. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with detectable HBV-DNA levels above the lower limit of detection in peripheral blood; positive for hepatitis C virus (HCV) antibodies with detectable HCV-RNA levels above the lower limit of detection; positive for human immunodeficiency virus (HIV) antibodies; positive for cytomegalovirus (CMV) DNA; positive for EBV-DNA; positive for syphilis serology.\n3. A history of severe allergic reactions \\[defined as allergic reactions of grade 2 or higher, with any of the following clinical manifestations: airway obstruction (rhinorrhea, cough, wheezing, dyspnea), tachycardia, hypotension, arrhythmia, gastrointestinal symptoms (nausea, vomiting), urinary or fecal incontinence, laryngeal edema, bronchial spasm, cyanosis, shock, respiratory or cardiac arrest\\] or known allergy to any active ingredient, excipient, or murine product or xenoprotein contained in the study drug (including the lymphodepletion regimen).\n4. Severe cardiac disease, including but not limited to severe arrhythmias, unstable angina, large myocardial infarction, New York Heart Association (NYHA) Class III or IV heart failure, refractory hypertension (defined as failure to achieve target blood pressure despite the use of a reasonable and tolerable regimen of ≥3 antihypertensive medications \\[including diuretics\\] for \\>1 month or requiring ≥4 antihypertensive medications for effective blood pressure control).\n5. History of solid organ transplant or planned solid organ transplant (excluding allogeneic hematopoietic stem cell transplant).\n6. Acute or chronic graft-versus-host disease (GVHD) that is deemed uncontrollable by the investigator.\n7. Allogeneic hematopoietic stem cell transplant within 6 months prior to screening.\n8. Active autoimmune or inflammatory disease (e.g., Guillain-Barré syndrome \\[GBS\\], amyotrophic lateral sclerosis \\[ALS\\]) or clinically significant active cerebrovascular disease (e.g., cerebral edema, posterior reversible encephalopathy syndrome \\[PRES\\]).\n9. Presence of a tumor emergency (e.g., spinal cord compression, bowel obstruction, leukostasis, tumor lysis syndrome) requiring urgent treatment prior to screening or infusion.\n10. Presence of uncontrollable bacterial, fungal, viral, or other infections requiring antibiotic therapy.\n11. Planned to undergo major surgery within 4 weeks prior to lymphodepletion or during the study period, or surgical wounds not fully healed prior to enrollment.\n12. Presence of severe psychiatric disorders.\n13. Within 1 week prior to planned PBMC collection, receiving systemic corticosteroids or immunosuppressive agents that are deemed by the investigator to affect cell preparation. a) Systemic corticosteroids: subjects receiving systemic corticosteroid therapy within 1 week prior to planned PBMC collection and deemed by the investigator to require long-term systemic corticosteroid therapy during the treatment period (excluding inhaled or topical use); b) Immunosuppressive agents: subjects receiving immunosuppressive agents within 1 week prior to planned PBMC collection.\n14. Received live-attenuated or live virus vaccines within 4 weeks prior to screening.\n15. History of alcoholism or drug abuse.\n16. Participation in another interventional clinical trial within 30 days prior to screening.\n17. Any subject deemed by the investigator, based on clinical judgment or standards of care, to have a contraindication to any study procedure or other medical conditions that may pose an unacceptable risk.","2 Years","65 Years",{"count":112,"type":21},20,[24,25],"This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U32 injection in patients with acute myeloid leukemia.",[29],[117,118,119],"CAR-T","CD38","CLL-1","2025-06-23",{"date":122,"type":41},"2025-06-25",{"date":124,"type":21},"2025-07-03",{"date":126,"type":21},"2029-12-31",{"name":128,"class":48},"Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":156},"100577062","phase-2-vaccination-against-human-papillomavirus-hpv-after-allogeneic-stem-cell-transplantation-100577062","NCT06793410","Vaccination Against Human Papillomavirus (HPV) After Allogeneic Stem Cell Transplantation","Vaccination Against Human Papillomavirus (HPV) in Women and Men After Stem Cell Transplantation","Inclusion Criteria:\n\n* Recipient of AlloSCT from related or unrelated donor.\n* Adults (men and women) ≥18 years up to and including 45 years of age for vaccination.\n* Patients can be included regardless of prior HPV vaccination prior to transplantation\n\nExclusion Criteria:\n\n* Severe thrombocytopenia (under 50 x 10\\^9) not allowing intramuscular injection\n* Severe acute GvHD grade III-IV.\n* Extensive chronic GvHD requiring treatment with prednisone doses above 0.7 mg\u002Fkg\u002Fday plus at least two other systemic treatments against GvHD (for example ruxolitinib or photopheresis).\n* Prednisone doses above 1mg\u002Fkg\u002Fday at study start.\n* Treatment with rituximab 6 months before start of vaccination. Doses given later (unusual) do not require exclusion.\n* Treatment within 3 months before start of vaccination with iv or sc immunoglobulin.\n* Pregnancy, pregnancy desire or active pregnancy planning during time vaccine is given and up to three months after last vaccine dose.\n* Treatment with blood thinning medication contraindicating intramuscular injection\n* Allergy against Gardasil 9","45 Years",{"count":138,"type":21},100,[25],"Patients who undergo allogeneic stem cell transplantation lose previously acquired immunity and are routinely revaccinated against many infectious diseases. For several reasons, these patients have a long-term immune deficiency due to the transplant itself (lack of immune reconstitution) and due to possible complications, primarily GvHD and its treatment. The risk of secondary malignancy in the long-term following an allogeneic bone marrow transplant is greatly increased, and secondary cancer cases account for a significant proportion of late deaths in both women and men after transplantation. Some of these secondary cancers are associated with HPV. The risk of cervical cancer has been reported to be 13 times increased compared to a healthy population.\n\nTherefore in this trial, the aim is to study immune response (antigen-specific antibody response) after vaccination with 9-valent HPV vaccine (Gardasil 9®) in adult women and men (up to and including 45 years of age) who have undergone allogeneic stem cell transplantation. In this trial, the sponsor will compare \"early\" (start 9 months after tx) with \"late\" (start 15 months after tx) vaccination.",[142,143,29,144,145],"Recipients of Allogeneic Stem Cell Transplantation","HPV (Human Papillomavirus)-Associated","Myelodysplastic Syndrome","Diffuse Large B Cell Lymphoma (DLBCL)","2025-06-04",{"date":148,"type":41},"2025-06-05",{"date":150,"type":41},"2025-05-12",{"date":152,"type":21},"2029-10-31",{"name":154,"class":155},"Vastra Gotaland Region","OTHER_GOV",5,{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":164,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":172,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":188},"100584659","phase-2-anti-nkg2a-monoclonal-antibody-for-aml-or-mds-patients-undergoing-haploidentical-transplantation-100584659","NCT06892223","Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation","Phase II Clinical Trial to Optimize the Dose of an Anti-NKG2A Monoclonal Antibody (humZ270 MAb, IPH2201) for Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Haploidentical Transplantation with Post- Transplantation Cyclophosphamide","Inclusion Criteria:\n\n1. Patients capable of providing informed consent according to ICH\u002F GCP, and national\u002Flocal regulations and be willing to comply with all study-related procedures.\n2. Adult patients aged ≥18 years old, without any restriction of gender and race.\n3. Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome\u002FMyeloproliferative neoplasm (MDS\u002FMPN).\n4. Patients lacking a HLA identical donor and receiving haploidentical stem cell transplant with GVHD\u002FHVG prophylaxis consisting of Cyclophosphamide: 40 or 50 mg\u002Fkg\u002Fday, day +3 and +4, Cyclosporine A: 3 mg\u002Fkg\u002Fday from day +5, Mycophenolate mofetil: 45 mg\u002Fkg\u002Fday, from day +5 to day +35.\n5. Patient who has received haplo-SCT with a myeloablative or reduced intensity or nonmyeloblative conditioning followed, either by a bone marrow or a peripheral blood stem cell (PBSC) graft.\n6. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 8 days prior to start of study drug for women of childbearing potential.\n7. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the patient receives his last dose of study therapy contraception.\n\nExclusion Criteria:\n\n1. Patients aged \\\u003C 18 years old.\n2. Active uncontrolled infections.\n3. CNS involvement of AML disease.\n4. Karnofsky performance status (KPS) \\\u003C60% or severe organ dysfunction, including a left ventricular ejection fraction \\\u003C40%, DLCO \\\u003C50% or creatinine clearance \\\u003C50 ml\u002Fmin (as per transplant eligibility).\n5. Pregnant or breast-feeding or intending to become pregnant during the study.\n6. Patients who rapidly relapse after allogenic-SCT before day 30 after allogenic-SCT.\n7. Patients who experience acute GVHD before day +30 after allogenic-SCT.\n8. Patients treated with a second allogeneic Allo-SCT.","99 Years",{"count":166,"type":21},42,[25],"The goal of this clinical trial is to evaluate the effectiveness and safety of the anti-NKG2A monoclonal antibody (Monalizumab) in patients undergoing haploidentical stem cell transplantation (Haplo-SCT) with post-transplantation cyclophosphamide (PT-Cy). The main questions this trial aims to answer are:\n\n* Does Monalizumab improve graft-versus-host disease-free and progression-free survival (GPFS) in patients after Haplo-SCT?\n* What are the safety and side effects of Monalizumab in this patient group?\n* How does Monalizumab affect the reconstitution and function of NK cells in patients undergoing Haplo-SCT?\n* Researchers will administer Monalizumab to participants on day +30 and +44 after transplantation to see if it enhances immune responses and prevents disease relapse or GVHD.\n\nParticipants will:\n\n* Receive Monalizumab intravenously at 1 mg\u002Fkg on day +30 and day +44 after Haplo-SCT\n* Be monitored for clinical outcomes such as GVHD, survival rates, and immune function for up to one year after the transplant\n* Undergo regular checkups and tests to assess the effectiveness and safety of the treatment",[29,170,171],"MDS (Myelodysplastic Syndrome)","MPN (Myeloproliferative Neoplasms)",[173,174,175,176,177,178],"MONALIZUMAB","ALLOGENIC TRANSPLANT","ACUTE MYELOID LEUKEMIA","MYELODYSPLASTIC SYNDROM","MYELOPROLIFERATIVE NEOPLASM","GVHD","2025-03-21",{"date":181,"type":41},"2025-03-24",{"date":183,"type":41},"2021-12-03",{"date":185,"type":21},"2026-12",{"name":187,"class":100},"Istituto Clinico Humanitas",2,{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":199,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":101},"100581281","effectiveness-of-early-intervention-in-palliative-care-for-acute-myeloid-leukemia-patients-comparing-to-standard-of-care-100581281","NCT06848270","Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care","Effectiveness of Early Intervention in Palliative Care for Acute Myeloid Leukemia Patients Comparing to Standard of Care: a Randomized Pragmatic Clinical Trial, 1:1 Ratio, Parallel Group and Superiority Study","Inclusion Criteria:\n\n* Capable of making decisions\n* Diagnosed with acute myeloid leukemia\n* Aged 70 years or less\n* Treated or referred for treatment at the Hematology department of Centro Hospitalar e Universitário de São João.\n\nExclusion Criteria:\n\n* All patients referred for \"best supportive care\", that is, for supportive care including treatment with cytoreductive intent.","70 Years",{"count":198,"type":21},50,[200],"NA","Hemato-oncology patients undergoing intensive chemotherapy treatments experience different types of symptoms during and after treatments, which are often refractory to the established therapy. Physical symptoms such as pain, dyspnea, mucositis, insomnia, loss of appetite, constipation and diarrhea, among others, have a huge impact on quality of life, temporarily until symptomatic control, but also permanently with the development of anxiety, depression, long-term fatigue and post-traumatic stress. As recommended by ASCO (American Society of Clinical Oncology), the palliative approach to oncological diseases must be as early as possible and be part of the \"standard of care\". However, the lack of concrete data on this topic in the last decade served as a barrier to the early integration of this same care for hemato-oncology patients in its various areas. Palliative care presupposes global, interdisciplinary action, carried out by specific teams that must act in situations of incurable or serious illness, in an advanced and progressive phase. The potential benefits can be countless and of significant importance, from the impact on quality of life, symptomatic control, reduction of anxiety and depression and even the promotion of informed and conscious choices at the end of life as well as the reduction of aggressive strategies. used at this stage of the disease.",[203,29],"Palliative Care",[205,206],"Acute myeloid leukaemia","Palliative care","2025-02-21",{"date":209,"type":41},"2025-02-27",{"date":211,"type":21},"2025-04-01",{"date":213,"type":21},"2026-08-01",{"name":215,"class":100},"Universidade do Porto",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":227,"conditions":228,"keywords":229,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":243},"100542630","phase-3-maaza-regimen-for-the-treatment-of-newly-diagnosed-acute-myeloid-leukemia-aml-100542630","NCT06345365","MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)","A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;\n2. Age 18-75 years old;\n3. Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST\u002FALT \\\u003C2 × ULN, serum creatinine \\\u003C1.5 × ULN, 80 ml\u002Fmin ≤ creatinine clearance ≤120 ml\u002Fmin;\n4. Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \\\u003C1.5 × ULN;\n5. Physical condition: ECOG score 0-2;\n6. Obtained informed consent signed by the patient or family.\n\nExclusion Criteria:\n\n1. Allergy or significant contraindication to any of the drugs involved in the protocol;\n2. Patients with concomitant myelofibrosis;\n3. Severe cardiac disease, including myocardial infarction and cardiac insufficiency;\n4. Concomitant malignant tumours of other organs;\n5. Patients with active tuberculosis and HIV-positive patients;\n6. Other blood system diseases at the same time;\n7. Pregnant or breastfeeding women;\n8. Inability to understand or comply with the study protocol;\n9. Previous intolerance or allergy to similar drugs;\n10. Concurrent participation in other clinical studies;\n11. Any other condition that prevents the study from proceeding.","75 Years",{"count":225,"type":21},154,[62],"Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine).",[29],[230,231,232,233],"Mitoxantrone liposome","Newly diagnosed AML patients","Ara-Cytarabine","Azacytidine","2024-04-09",{"date":236,"type":41},"2024-04-10",{"date":238,"type":41},"2024-01-18",{"date":240,"type":21},"2028-12-31",{"name":242,"class":100},"Zhongnan Hospital",11]