[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myeloid-leukemia":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,54,80,100,137,170,225],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100615412","halt-aging-in-survivors-of-blood-cancers-100615412",false,"NCT07292272","Halt Aging in Survivors of Blood Cancers","Halt Aging in Survivors of Blood Cancers: the HALTAging-1 Study","HALTAging-1","Inclusion Criteria:\n\n1. Age ≥50 years\n2. A history of hematological malignancy\n3. Participants must be able to and willingly give informed consent\n\nExclusion Criteria:\n\n1. Patients receiving intensive induction or consolidation chemotherapy. Maintenance chemotherapy, or lower-intensity chemotherapy for an indolent hematological malignancy is allowed.\n2. Neurodegenerative disease (e.g. Alzheimer's dementia), stroke, or uncontrolled psychotic disorders (e.g. schizophrenia or bipolar disorder) in the past 3 months if those disorders are considered significant enough to impair participation in the study.\n3. Illnesses such as clinical evidence of decompensated heart failure, unstable angina, or orthopedic or neuromuscular disorders that could limit safe participation in aerobic exercise.\n4. Cardiopulmonary exercise test results that preclude safe exercise (e.g., life-threatening arrhythmia, balance difficulties, peak VO2 \\\u003C10 ml\u002Fkg\u002Fmin).\n5. Estimated life expectancy of less than 6 months (that precludes assessment of study primary endpoint).\n6. Self-reported pregnancy or the possibility of pregnancy.\n7. Participants who do not plan to follow up at the participating center.","ALL","50 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"NA","Older survivors of blood cancer are at a high risk of accelerated biological aging, which increases their risk of developing multiple aging-related conditions. Whereas physical exercise can improve overall health, older cancer survivors do not meet the recommended physical activity, highlighting the need to develop behavioral interventions to increase adherence. Several other knowledge gaps exist to implement exercise interventions in older survivors of blood cancer; the dose and duration of exercise necessary to slow biological aging in older blood cancer survivors remain unknown. To bridge these gaps in knowledge, we have designed a Phase 2 randomized control trial to test the effects of behavioral and exercise interventions on various outcomes.",[27,28,29,30,31,32,33,34],"Hematological Malignancy","Leukemia","Lymphoid Leukemia","Multiple Myeloma","Myeloid Leukemia","Monocytic Leukemia","Non-hodgkin Lymphoma","Other Hematologic Condition",[36,28,29,30,31,32,33,34,37,38,39,40],"Hodgkin Lymphoma","Epigenetic clock","Biological aging","Quality of life","Blood cancer survivors","RECRUITING","2026-06-29",{"date":44,"type":45},"2026-07-01","ACTUAL",{"date":47,"type":45},"2026-04-09",{"date":49,"type":21},"2033-03-25",{"name":51,"class":52},"University of Nebraska","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":53},"100643726","phase-1-phase-12-flag-ida-ven-and-asciminib-in-cml-and-ph-aml-100643726","NCT07604233","Phase 1\u002F2 FLAG-IDA, VEN and Asciminib in CML and Ph+ AML","Phase Ib\u002FII of the Combination of Fludarabine, Cytarabine, Idarubicin, G-CSF (FLAG-Ida) With Venetoclax and Asciminib in Patients With Advanced Phase Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Age 18 to 70 years. Because no dosing or adverse event data are currently available on the use of the combination of FLAG-Ida with venetoclax and asciminib in patients \\\u003C18 years of age, children are excluded from this study.\n* Newly diagnosed or relapsed\u002Frefractory:\n\n  * BCR::ABL1-rearranged CML in myeloid BP or Philadelphia chromosomepositive or BCR::ABL1-rearranged AML as defined by the WHO 2022 criteria23\n  * BCR::ABL1-rearranged CML in lymphoid BP.\n* ECOG performance status ≤ 2.\n* Adequate liver, cardiac, renal and pancreatic function as defined by the following criteria:\n\n  * Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis, or the underlying leukemia approved by the Principal Investigator (PI)\n  * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 3 x ULN, unless due to the underlying leukemia approved by the PI\n  * Creatinine clearance ≥ 30 mL\u002Fmin\n  * Serum amylase or lipase ≤ 1.5 x ULN\n  * Left ventricular ejection fraction ≥ 40%.\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* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Because the therapeutic agents used in this trial could potentially be teratogenic, women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. This includes all female patients, up until the age of 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* Approved 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* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of trial treatment\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents used for the treatment of other cancers.\n* Patients who have progressed on asciminib and\u002For a combination of intensive chemotherapy plus venetoclax. Patients with prior treatment with a hypomethylating agent and venetoclax will be eligible.\n* Active grade III-V cardiac failure as defined by the New York Heart Association Criteria.\n* Myocardial infarction, unstable angina, or stroke within 3 months prior to signing informed consent.\n* Clinically significant atrial or ventricular arrhythmias (such as uncontrolled, clinically significant atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician.\n* Prolonged QTcF interval on pre-entry electrocardiogram (\\> 470 msec) unless corrected after electrolyte replacement or approved by a cardiologist.\n* History of acute pancreatitis within 6 months or medical history of chronic pancreatitis.\n* Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment).\n* Active secondary malignancy that in the investigator's opinion will shorten survival to less than one year.\n* Treatment with any investigational antileukemic agent in the last 14 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea, cytarabine (up to 2 g\u002Fm2 given for cytoreduction within the preceding 7 days) and\u002For an FDA-approved BCR::ABL1 TKI is permitted.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the combination of FLAG-Ida, venetoclax, asciminib, or blinatumomab.\n* Pregnant women are excluded from this study because study drugs have 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 study drugs, breastfeeding should be discontinued.\n* Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","18 Years","70 Years",{"count":64,"type":21},30,[66,67],"PHASE1","PHASE2","The goal of Phase 1b is to establish the safety of asciminib in combination with FLAG-Ida and venetoclax in patients with CML-MBP, CML-LBP, and Ph+ AML. The goal of Phase 2 is to learn if asciminib in combination with FLAG-Ida and venetoclax can help to control the disease.",[31],"NOT_YET_RECRUITING","2026-06-04",{"date":73,"type":45},"2026-06-08",{"date":75,"type":21},"2026-11-30",{"date":77,"type":21},"2033-06-03",{"name":79,"class":52},"M.D. Anderson Cancer Center",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":53},"100549087","phase-1-mitoxantrone-for-venetoclax-resistant-acute-myeloid-leukemia-100549087","NCT06429449","Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Subject must have confirmation of non-APL AML by WHO criteria and have been treated with first-line venetoclax\u002FHMA (azacitidine or decitabine).\n2. Subject must have relapsed disease per IWG criteria or disease refractory to first line venetoclax\u002FHMA defined by less than a PR response after ≥ 1 complete cycle of venetoclax\u002FHMA.\n3. Subject must have either measurable residual disease (MRD+), as measured by FDA-approved flow cytometric test performed by Hematologics (cohort 3 and 4) or relapsed\u002Frefractory disease (cohort 1 and 2).\n4. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 2.\n5. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL\u002Fmin, calculated using the formula CKD-EPI Creatinine Equation\n6. Subject must have adequate heart function as measured by left ventricular ejection fraction (LVEF) \\>50%, assessed by multigated acquisition (MUGA) or echocardiogram (ECHO) within 1 month prior to study day 1\n7. Subject must have adequate liver function as demonstrated by:\n\n   1. aspartate aminotransferase (AST) ≤ 3.0 × ULN\\*\n   2. alanine aminotransferase (ALT) ≤ 3.0 × ULN\\*\n   3. bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome\\*\n\n      * Unless considered due to leukemic organ involvement\n8. Non-sterile male subjects must use contraceptive methods with partner(s) at least prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. No contraception is required if male subjects are surgically sterile (vasectomy with medical assessment confirming surgical success) or if the male subject has a female partner who is postmenopausal or permanently sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).\n9. Female subjects must be either:\n\n   1. Postmenopausal; defined as Age \\> 60 years with no menses for 12 or more months without an alternative medical cause; OR\n   2. Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy); OR\n   3. If subject is of childbearing potential, use of contraception is required while on study treatment and for 6 months after the last dose.\n10. Subject must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB), prior to the initiation of any research directed procedures.\n\nExclusion Criteria:\n\n1. Subject has known active CNS involvement from AML.\n2. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his\u002Fher participating in this study including, but not limited to:\n\n   1. Significant active cardiac disease within the previous 6 months including: New York Heart Association heart failure \\> class 2, unstable angina, or myocardial infarction.\n   2. Renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.\n3. Subject has a malabsorption syndrome or other condition that precludes enteral route of administration. This includes history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease (e.g.\n\n   sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug and\u002For predispose the subject to an increased risk of gastrointestinal toxicity.\n4. Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial or fungal). Uncontrolled is defined as ongoing signs\u002Fsymptoms related the infection without improvement despite appropriate antibiotics, antiviral therapy and\u002For other treatment.\n5. Subject has a history of other malignancies prior to study entry, with the exception of:\n\n   1. Adequately treated in situ carcinoma of the breast or cervix uteri\n   2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin\n   3. Prostate cancer not requiring therapy beyond hormonal therapy\n   4. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent\n6. Subject has a white blood cell count \\> 25 × 109\u002FL. Note: hydroxyurea or apheresis are permitted to meet this criterion (cohort 3 only).\n7. Pregnant or breast-feeding females.\n8. Known or suspected hypersensitivity to azacitidine or mannitol.\n9. Any prior exposure to an anthracycline or anthracenedione","80 Years",{"count":64,"type":21},[66],"This is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.",[28,31,32],"2026-01-13",{"date":93,"type":45},"2026-01-15",{"date":95,"type":45},"2024-07-21",{"date":97,"type":21},"2027-11",{"name":99,"class":52},"University of Colorado, Denver",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":119,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100454196","phase-2-exercise-training-and-nr-supplementation-trial-to-improve-fitness-in-aya-hct-survivors-100454196","NCT05194397","Exercise Training and NR Supplementation Trial to Improve Fitness in AYA HCT Survivors","Intensive Tailored Exercise Training With NAD+ Precursor Supplementation to Improve Muscle Mass and Fitness in Adolescent and Young Adult Hematopoietic Cell Transplant Survivors","IAMFIT","Inclusion Criteria:\n\n1. Males and females, ages 10-30 years at enrollment\n2. Able to understand and speak English\n3. Diagnosis of leukemia (myeloid, lymphoid), aplastic anemia, bone marrow failure syndrome, or myelodysplastic syndrome requiring allogeneic HCT\n4. 6-48 months from allogeneic HCT\n5. Females must have a negative urine\u002Fserum pregnancy test and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study.\n6. Subject's informed consent or parental\u002Fguardian permission (informed consent) and if appropriate, child assent\n7. Minimum weight of 24 kg\n\nExclusion Criteria:\n\n1. Known sensitivity to NR\n2. Concurrent use of any medications, including statins, likely to increase risk of NR toxicity\n3. Active malignancy, investigational agent(s) within 4 wks, or supraphysiological glucocorticoids at the baseline visit\n4. Currently meeting public health exercise guidelines\n5. Use of NAD+ precursors (supra-physiologic) within 4 weeks\n6. Hemoglobin \\\u003C 10 g\u002FdL\n7. Platelets \\\u003C 50K\n8. Diabetes Mellitus requiring insulin or insulin secretagogue\n9. HbA1C ≥ 8% or fasting glucose \\> 125 mg\u002FdL; However if the participant is diabetic, both fasting glucose level and HbA1C must meet the criteria to be deemed eligible.\n10. Kidney disease (eGFR \\\u003C 60 ml\u002Fmin\u002F1.73 m2)\n11. Liver disease Alanine aminotransferase (ALT)\u002FAspartate aminotransferase (AST) (ALT\u002FAST \\> 3 x ULN)\n12. Limitations in physical function preventing exercise testing\u002Ftraining\n13. Unstable angina or history of acute myocardial infarction (\\\u003C5 days of planned study procedures)\n14. Recurrent syncope\n15. Symptomatic severe aortic stenosis\n16. Uncontrolled arrhythmia causing symptoms\n17. Pulmonary embolus \\\u003C3 months of study procedures\n18. Thrombosis of lower extremities\n19. Symptomatic moderate or severe persistent asthma based on Forced Expiratory Volume (FEV) from pre-HCT pulmonary function testing\n20. Room air desaturation at rest ≤85%\n21. Females: Pregnant or planning pregnancy\n22. Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (e.g. infection, renal failure, thyrotoxicosis, \\>moderate Graft versus host disease (GVHD) resulting in physical or functional impairment)\n23. Parents\u002Fguardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.\n24. For MRI procedure: Contraindications to MRI. Individuals will be screened to ensure they can safely complete the MRI. \\*participants who cannot complete the MRI will not be excluded from participation in the remainder of the study procedures if they meet those inclusion and exclusion criteria.\n25. Current weight precludes safe completion of study procedures","10 Years","30 Years",{"count":111,"type":21},80,[67],"This will be a randomized, placebo-controlled trial with a 2x2 factorial design testing the effects of an NAD+ precursor (NR) and exercise on skeletal muscle quality and VO2max in AYA HCT survivors.\n\nThe primary outcome is the change in muscle strength (isometric knee extension) from baseline to 16 weeks. Key secondary outcomes are the change in muscle strength (ankle plantarflexion) from baseline to 16 weeks, the change in grip strength from baseline to 16 weeks, the change in lower extremity muscle mass from baseline to 16 weeks, the change in muscle OXPHOS capacity from baseline to 16 weeks, and the change in aerobic capacity (VO2 max) from baseline to 16 weeks.",[115,116,117,118,31],"Lymphoblastic Leukemia","Cancer Survivors","Aplastic Anemia","Myelodysplastic Syndromes",[120,121,122,123,124,125,116,126],"Sarcopenia","NAD+","Exercise Intervention","OXPHOS Capacity","VO2 Max","Adolescent young adults","Hematopoietic Stem Cell Transplantation (HCT)","2025-12-02",{"date":129,"type":45},"2025-12-04",{"date":131,"type":45},"2023-02-23",{"date":133,"type":21},"2026-06-30",{"name":135,"class":52},"Children's Hospital of Philadelphia",3,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":147,"conditions":148,"keywords":153,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":169},"100382468","phase-1-study-of-hqp1351-in-subjects-with-refractory-cml-and-ph-all-100382468","NCT04260022","Study of HQP1351 in Subjects With Refractory CML and Ph+ ALL","A Phase Ib Study of the Pharmacokinetics, Safety and Efficacy of Orally Administered HQP1351 in Subjects With Refractory Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)","Inclusion Criteria:\n\n* For HQP1351 monotherapy, patients must have CML in any phase (CP, AP, or BP of any phenotype) or Ph+ ALL, with or without T315I mutation\n* For Cohort D, patients with Ph+ BCP ALL or CML LBP must be resistant or intolerant to at least one second or later generation TKI, such as dasatinib, nilotinib, bosutinib and ponatinib, despite optimal supportive care\n* For HQP1351 monotherapy only: Be previously treated with and developed resistance or intolerance to at least two TKIs including ponatinib, imatinib, dasatinib, nilotinib, bosutinib, and asciminib. For patients with a T315I mutation, number of pretreated TKIs is not restricted.\n\n  1. The definition of resistance to first-line TKI treatment refers to European Leukemia Net (ELN) recommendations. The definitions are the same for patients in CP, AP, BP, and Ph+ ALL, and apply also to second-line treatment, when first-line treatment was changed for intolerance. The patients must meet at least one criterion:\n\n     1. Three months after the initiation of therapy: non-complete hematologic response (CHR) and\u002For Ph+ \\>95%\n     2. Six months after the initiation of therapy: BCR-ABL1\\>10% and\u002For Ph+ \\>35%\n     3. Twelve months after the initiation of therapy: BCR-ABL1\\>1% and\u002For Ph+ \\>0%\n     4. Then, and at any time after the initiation of therapy: Loss of CHR, or loss of complete cytogenetic response (CCyR), or confirmed loss of major molecular response (MMR) (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), mutations, clonal chromosome abnormalities in Ph+ cells (CCA\u002FPh+)\n  2. The definition of resistance to second-line TKI treatment\n\n     a) For CML CP patients: the patients must meet at least one criterion as follows:\n\n     i.) Three months after the initiation of therapy: No CHR or Ph+ \\>95% or new mutations\n\n     ii.) Six months after the initiation of therapy: BCR-ABL1\\>10% and\u002For Ph+ \\>65% and\u002For new mutations\n\n     iii.) Twelve months after the initiation of therapy: BCR-ABL1\\>1% and\u002For Ph+ \\>35% and\u002For new mutations\n\n     iv.) Then, and at any time after the initiation of therapy: Loss of CHR or loss of CCyR, new mutations, confirmed loss of MMR (In 2 consecutive tests, of which one with a BCR-ABL1 transcripts level ≥1%), clonal chromosome abnormalities in Ph+ cells (CCA\u002FPh+)\n\n     b) For CML AP patients: the patients must meet at least one criterion as follows:\n\n     i.) Three months after the initiation of therapy: failure to achieve a major hematologic response (MaHR)\n\n     ii.) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 4 weeks\n\n     iii.) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR\n\n     c) For CML BP and Ph+ ALL patients: the patients must meet at least one criterion as follows:\n\n     i) One month after the initiation of therapy: failure to achieve a MaHR\n\n     ii) At any time after the initiation of therapy, the loss of a MaHR, confirmed in at least 2 consecutive analyses separated by at least 1 week\n\n     iii) At any time after the initiation of therapy, the development of new BCR-ABL kinase domain mutations in the absence of a MaHR\n  3. Intolerance to TKIs is defined as:\n\n     1. Non-hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP\u002FBP or Ph+ ALL patients\n     2. Hematological AEs: patients with grade 3 or 4 toxicity during TKIs treatment, that is recurrent after unresponsive after optimal management, including dose adjustments in the absence of a CCyR for CP patients or MaHR for AP\u002FBP or Ph+ ALL patients\n* Patients providing written informed consent before initiation of any study-related activities\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n* Minimum life expectancy of 3 months or more\n* Patients with adequate organ function as defined below:\n\n  1. Creatinine \\\u003C 2 × upper limit of normal (ULN); or, creatinine \\> 2 × ULN, with 24h glomerular filtration rate (GFR) ≥ 30 mL\u002Fmin (Cockcroft-Gault)\n  2. Serum albumin ≥ 3.0 g\u002FdL\n  3. Total bilirubin \\\u003C 1.5 × ULN\n  4. Aspartate aminotransferase (AST \\[Serum glutamic oxaloacetic transaminase (SGOT)\\]) and alanine aminotransferase (ALT \\[serum glutamate-pyruvate transaminase (SGPT)\\]) \\\u003C 3 × ULN for institution (\\\u003C5×ULN if liver involvement with leukemia)\n  5. Serum amylase and lipase ≤ 1.5 × ULN\n  6. Prothrombin time (PT) ≤ 1.5 × ULN\n* Heart function: Left ventricular ejection fraction (LVEF) \\> 50%\n* Normal QT interval corrected Fridericia (QTcF) interval on screening electrocardiogram (ECG) evaluation: male ≤450ms, female ≤470ms\n* For females of childbearing potential, a negative pregnancy test must be established before enrollment. And the eligible female and male patients with childbearing potential must agree to use an effective form of contraception with their sexual partners throughout participation in this study\n* Ability to comply with study procedures, in the Investigator's opinion\n\nExclusion Criteria:\n\n* Received TKI therapy within 5 half-lives or 7 days prior to first dose of HQP1351, whichever is shorter, or any adverse events (AEs) (except alopecia and pigmentation) not recovered to CTCAE v5.0 grade 0-1 due to any other treatments\n* Received other therapies as follows:\n\n  1. For CP and AP patients, received hydroxyurea or anagrelide within 24 hours prior to the first dose of HQP1351; or, interferon, immunotherapy or cytarabine within 14 days prior to the first dose of HQP1351; or, any other radiotherapy, cytotoxic chemotherapy or investigational therapy within 28 days prior to receiving the first dose of HQP1351\n  2. For BP patients, received chemotherapy within 7 days prior to the first dose of HQP1351\n  3. For Ph+ ALL patients, received corticosteroids within 24 hours before the first dose of HQP1351, or received chemotherapy within 7 days prior to the first dose of HQP1351\n  4. Patients who are currently receiving treatment with a medication that has the potential to interact with HQP1351\n  5. Patients who had been treated with HQP1351\n  6. Patients requiring immunosuppressive therapy other than short time of steroid\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter absorption of study drugs\n* Patients with cardiovascular diseases, including uncontrolled high blood pressure (HBP) (that is blood pressure \\>140\u002F90mmHg.); or, receiving drugs that can cause prolonged QT interval. Patients with well controlled HBP can be considered to be included. (\"well controlled HBP\" is defined as: HBP can be ≤ 140\u002F90mmHg with antihypertensive treatment). Those requiring 3 or more antihypertensive medications should be discussed with the medical monitor.\n* Have clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n  1. Any history of myocardial infarction (MI) within 6 months or unstable angina within 3 months\n  2. Any history of cerebrovascular accident within 1 year, or transient ischemic attack (TIA) within 3 months\n  3. Any history of peripheral vascular infarction, including visceral infarction within 6 months\n  4. Congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] class III or IV) within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal, per local institutional standards, within 6 months prior to enrollment\n  5. History of clinically significant (as determined by the treating physician) atrial arrhythmia or any history of ventricular arrhythmia\n  6. Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 3 months prior to enrollment. Patients who have experienced a venous thromboembolic event should only be eligible if the condition is well controlled with optimal intervention (as determined by the treating physician). Continued prophylactic anticoagulation is acceptable.\n  7. Patients with revascularization procedures including cardiac bypass within the 6 months and stenting within the past 3 months should be excluded.\n* Have history of autologous or allogeneic stem cell transplant, or with active graft-versus-host disease (GVHD), or active immune suppression in recent 6 months prior to informed consent date or active immune suppression in recent 6 months prior to informed consent date\n* CML CP patients with CCyR\n* Patients who have a significant bleeding disorder unrelated to CML or Ph+ ALL\n* Patients who had a major surgery within 4 weeks prior to study entry or have not recovered from side effects of such surgery which the Investigator considers not appropriate for enrollment\n* Cytologically confirmed central nervous system (CNS) involvement (if asymptomatic, spinal fluid examination is not necessary prior to first treatment)\n* Patients with another primary malignancy within 1 year of study entry. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are considered disease-free at the time of study entry.\n* Have ongoing or active infection, including known history of immunodeficiency virus (HIV) or HIV antibody positive, hepatitis B virus (HBV) or HBsAg positive, hepatitis C virus (HCV). Patients who have positive HCV antibody must have an undetectable HCV viral load.\n* Patients with COVID-19 who now present with positive swab\n* Patients who have poorly controlled diabetes, defined as HbA1C values of \\> 7.5%. Patients with pre-existing, well-controlled diabetes are not excluded.\n* Known allergy to any components in the study drug\n* Pregnant or lactating\n* Patients who have any conditions or illness that, according to the opinions of the investigator or the medical monitor, would comprise patient safety or interfere with the evaluation of safety and efficacy to the study drug",{"count":145,"type":21},242,[66],"A multi-center, open-label, randomized, phase Ib study to evaluate the pharmacokinetics (PK) of HQP1351 and to determine the recommended phase 2 dose (RP2D) of HQP1351 in subjects with CML chronic phase (CP), accelerated phase (AP), or blast phase (BP) or with Ph+ ALL, who have experienced resistance or intolerance to at least two tyrosine kinase inhibitors (TKIs) or in subjects with Ph+ B-cell precursor (BCP) ALL or lymphoid blast phase CML (CML LBP), who have experienced resistance or intolerance to at least one second or later generation TKI.",[149,31,150,151,152],"Leukemia, Myeloid, Chronic","Chronic Myeloid Leukemia","Philadelphia Positive Acute Lymphoblastic Leukemia","B Cell Precursor Type Acute Leukemia",[154,155,156,157,158],"T315I mutation","Chronic Phase","Accelerated Phase","Blast Phase","Lymphoid blast phase","2025-11-04",{"date":161,"type":45},"2025-11-05",{"date":163,"type":45},"2020-01-09",{"date":165,"type":21},"2030-03-31",{"name":167,"class":168},"Ascentage Pharma Group Inc.","INDUSTRY",9,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":61,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":181,"conditions":182,"keywords":193,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100605053","phase-2-radioimmunotherapy-conditioning-with-131i--apamistamab-for-allogeneic-transplant-in-relapserefractory-aml-100605053","NCT07157514","Radioimmunotherapy Conditioning With 131I- Apamistamab for Allogeneic Transplant in Relapse\u002FRefractory AML","An Adaptive, Operationally Seamless Phase II \u002F III Study of 131I-apamistamab-Led Allogeneic Hematopoietic Stem Cell Transplant in Patients With Relapsed or Refractory Acute Myeloid Leukemia With Active Disease","Inclusion Criteria:\n\n1. Have active, relapsed, or refractory AML with ≥5% and ≤20% blasts in the marrow.\n2. 2R\u002FR AML is defined as one of the following: Primary induction failure after ≥2 cycles of therapy, first early relapse after remission \\\u003C6 months, relapse refractory to salvage combination therapy or second or subsequent relapse\n3. Documented CD45 expression by leukemic cells via flow cytometry.\n4. ≥18 years of age and not suitable for myeloablative conditioning regimen.\n5. Circulating blast count \\\u003C10,000\u002Fmm³ (hydroxyurea allowed).\n6. Calculated creatinine clearance (Cockcroft-Gault) \\>50 mL\u002Fmin.\n7. Adequate hepatic function: AST\u002FALT ≤2 × ULN; total bilirubin ≤1.5 × ULN (≤3 × ULN if due to underlying malignancy or Gilbert's).\n8. Karnofsky performance score ≥70.\n9. Expected survival \\>60 days.\n10. Central venous catheter line in place before study treatment.\n11. 8\u002F8 HLA-matched related or unrelated donor (HLA-A, HLA-B, HLA-C, DRB1).\n12. Women of childbearing potential must be surgically sterile or use acceptable contraception through 1-year post-transplant.\n13. Men with partners of childbearing potential must be surgically sterile or use acceptable contraception through 12 weeks after last dose.\n14. Able to understand procedures, provide informed consent, and comply with study requirements.\n\nExclusion Criteria:\n\n1. Positive human anti-mouse antibody (HAMA) at screening.\n2. \\>20% leukemic blasts in marrow.\n3. Prior radiation to maximally tolerated levels of any critical organ.\n4. Active CNS leukemia (blasts in CSF or CNS chloromas).\n5. Prior allogeneic or autologous HSCT.\n6. Candidates suitable for myeloablative conditioning.\n7. Clinically significant cardiac disease, including: NYHA Class III or IV heart failure, Clinically significant arrhythmias (ventricular tachycardia, ventricular fibrillation, Torsade de Pointes), Myocardial infarction with uncontrolled angina within 6 months, Clinically significant congestive heart failure or cardiomyopathy\n8. QTcF \\>450 ms after correction of electrolytes (unless paced rhythm or investigator deems eligible; cardiology consult optional).\n9. Positive HIV, HBV, or HCV test (exceptions: vaccinated HBV, or positive hepatitis markers with adequate organ function).\n10. Active, uncontrolled infection.\n11. Acute promyelocytic leukemia (t\\[15;17\\]).\n12. Active malignancy within 2 years, except: Myelodysplastic syndrome, Treated non-melanoma skin cancer, Completely resected stage 0-1 melanoma (\\>1 year from resection), Carcinoma in situ or cervical intraepithelial neoplasia, Organ-confined prostate cancer without progression\n13. Inability to tolerate diagnostic or therapeutic procedures, particularly radiation isolation.\n14. Received anti-leukemic therapy within 14 days prior to randomization (hydroxyurea allowed up to day of 131I-apamistamab).",{"count":178,"type":21},306,[67,180],"PHASE3","This is a multicenter, open-label study in people aged 18 and older with relapsed or refractory acute myeloid leukemia. It has two parts. In Phase 2, we are testing three radiation dose levels of 131I-apamistamab combined with fludarabine and low-dose whole-body radiation before stem cell transplant to find the safest and most effective dose. In Phase 3, patients will be randomly assigned to receive either this treatment combination or a standard of care regimen before transplant. The main goal is to see if the new approach helps people live longer. Phase 2 will enroll about 60 people, and Phase 3 will enroll about 246 people.",[183,31,184,185,186,187,188,189,190,191,192],"Acute Leukemia","Acute Myelogenous Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia, in Relapse","Myelogenous Leukemia","Myelogenous Leukemia, Acute","Myelogenous Leukemia in Relapse","Transplant-Related Disorder","Allogeneic Disease","Refractory AML",[185,28,194,195,196,197,192,198,199,200,201,202,203,204,205,206,207,208,209,210,211,212,213,214,215],"Acute Myeloid","Acute Bone Marrow Cell Transplant","Transplant","Bone Marrow HCT","Relapsed AML","I-131","Iomab","I131- Apamistamab","Iodine","Iodine-131","131-I AML","Iomab-B","Radioimmunotherapy","Allogeneic Transplant","Radiotherapy","CD45","Anti-CD45 antibody","Apamistamab","Fludarabine","Bone Marrow Transplant","Radiolabeled antibody therapy","131I -apamistamab","2025-09-04",{"date":218,"type":45},"2025-09-10",{"date":220,"type":21},"2026-01",{"date":222,"type":21},"2034-02",{"name":224,"class":168},"Actinium Pharmaceuticals",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":232,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":249,"locationsCount":53},"100526118","phase-2-interferon--for-tp53-myeloid-malignancy-post-allo-hsct-100526118","NCT06130579","Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT","Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT","Inclusion Criteria:\n\n1. Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia (2022ICC) criteria, acute myeloid leukemia (AML) with TP53 mutation (unrestricted remission status), minimal residual disease (MRD) monitored by flow cytometry within 2 months after receiving the first allogeneic hematopoietic stem cell transplantation Negative patients\n2. Male or female, aged 12-65 years\n3. Karnofsky score \\>60, estimated survival time \\>3 months\n4. No history of severe graft-versus-host disease (GVHD), uncontrolled GVHD, or severe systemic organ dysfunction:\n\n   1. Absolute neutrophil count (ANC) greater than 0.5×109\u002FL\n   2. Creatinine \\\u003C 1.5mg\u002FdL\n   3. Cardiac ejection index \\>55%\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. severe cardiac, renal, or liver dysfunction\n2. combined with other malignant tumors requiring treatment\n3. inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness\n4. patients who are unable to complete the necessary treatment plan and follow-up observation\n5. patients with severe acute anaphylaxis\n6. clinically uncontrolled severe life-threatening infections\n7. patients enrolled in other clinical trials\n8. other reasons considered by the investigator to be inappropriate for clinical trial participants.","12 Years","65 Years",{"count":235,"type":21},35,[67],"To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML\u002FMDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[31,118],[240,241,242],"IFN-α","Preventing relapse","allo-HSCT","2025-05-28",{"date":245,"type":45},"2025-06-03",{"date":247,"type":45},"2024-01-01",{"date":133,"type":21},{"name":250,"class":52},"Peking University People's Hospital"]