[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myeloid-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myeloid-neoplasm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,42,76,103,134,155,191],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100600227","randomization-for-the-identification-of-best-treatment-intensity-for-less-fit-adults-with-acute-myeloid-leukemia-and-myeloid-neoplasms-100600227",false,"NCT07094750","Randomization for the Identification of Best Treatment Intensity for Less Fit Adults With Acute Myeloid Leukemia and Myeloid Neoplasms","Impact of Treatment Intensity on Survival, Quality of Life, and Resource Utilization in Medically Less Fit Adults With Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms: A Randomized Pilot Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of high grade myeloid neoplasm (\\> 10% blasts in blood or marrow), other than acute promyelocytic leukemia (APL) according to the 2022 International Consensus Classification (ICC) classification. Patients with acute leukemias of ambiguous lineage are eligible\n* The use of cytoreductive therapy before treatment is permitted. Patients with symptoms\u002Fsigns of leukostasis, white blood cell (WBC) \\> 100,000\u002FμL, or acute symptoms that in the opinion of the treating physician are likely related to their high-grade myeloid neoplasm may receive up to 2 doses of cytarabine (up to 500 mg\u002Fm\\^2 each) prior to study day 1\n* Patients may have received treatment for antecedent low-grade myeloid neoplasm (\\\u003C 10% myeloid blasts on blood or bone marrow)\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3 (for patients aged \\\u003C 75 years) or ECOG performance status of 0 - 2 (for patients aged ≥ 75 years)\n* The presence of one or more of the following criteria for 'unfitness'. (Patients without respiratory symptoms at rest are eligible and should only complete spirometry\u002Fdiffusion capacity of the lung for carbon monoxide \\[DLCO\\] measurements as clinically indicated):\n\n  * ECOG Performance Status of 2 or 3\n  * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina\n  * Documented DLCO ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%; or dyspnea at rest, or requiring supplemental oxygen\n  * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 45 ml\u002Fmin\n  * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 × upper limit of normal (ULN)\n  * Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy\n* Adequate cardiac function:\n\n  * Patients aged ≤ 60 years without a history of cardiac disease or evidence of heart failure are eligible if they also exhibit the following:\n\n    * Chest x-ray (CXR) without evidence of moderate or severe pulmonary edema or pleural effusion, and a normal cardio-mediastinal silhouette\n    * Electrocardiogram (ECG) without evidence of atrial or ventricular chamber enlargement\n    * Note that patients with either abnormal CXR or ECG should have a structural heart assessment (echocardiogram, multigated acquisition scan \\[MUGA\\] or similar) and are eligible if left ventricular ejection fraction (LVEF) \\> 40% and the abnormalities in the CXR\u002FECG do not preclude safe administration of intensive chemotherapy\n  * Patients with a documented left ventricular ejection fraction (LVEF) ≥ 40%, assessed within 3 months prior to registration, e.g. by MUGA scan or echocardiography, or another appropriate diagnostic modality are eligible\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x ULN, unless judged due to leukemic organ involvement\n* Total bilirubin ≤ 3 x ULN unless judged due to leukemic organ involvement, Gilbert's syndrome, or hemolysis\n* Women of childbearing potential and men must agree to use adequate contraception beginning at the signing of the consent until at least 4 weeks after the last dose of study drug\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Known hypersensitivity to cytarabine, anthracycline, hypomethylating agents, or venetoclax\n* Cardiovascular disability status of New York Heart Association class ≥ 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea, or anginal pain\n* Subject exhibits evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial or fungal)\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active pregnancy or breast feeding","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"NA","This clinical trial studies whether less fit adults with acute myeloid leukemia (AML) or myeloid neoplasms are willing to let a computer program decide (randomization) whether they receive lower- or higher-intensity chemotherapy. Historically, treatment decision-making for patients with AML or myeloid neoplasms has divided patients into two categories, with patients considered fit receiving intensive \"curative\" chemotherapy, and patients considered unfit, such as older patients with a higher risk of early death from therapy, receiving non-intensive \"palliative\" therapy or no therapy. With the introduction of new treatment agents, it has become difficult to determine the difference between intensive and non-intensive therapy, especially for patients considered unfit for whom treatment-related side effects remain a concern. Treatment intensity is best identified through randomized trials but often patients are unwilling to undergo randomization due to preset beliefs. However, with improved supportive care and the awareness that new treatment agents may have similar risks as intensive therapy, it may be possible that more patients are willing to be randomized. This may help identify the best treatment intensity for less fit adults with AML or myeloid neoplasms, which may improve outcomes.",[26,27,28],"Acute Leukemia of Ambiguous Lineage","Acute Myeloid Leukemia","Myeloid Neoplasm","RECRUITING","2026-06-10",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":20},"2026-07-01",{"date":37,"type":20},"2029-06-08",{"name":39,"class":40},"Fred Hutchinson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":41},"100423737","phase-1-venetoclax-and-clag-m-for-the-treatment-of-acute-myeloid-leukemia-and-high-grade-myeloid-neoplasms-100423737","NCT04797767","Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms","A Phase 1\u002F2 Single-Center Trial Combining Venetoclax With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (CLAG-M) for Patients With AML and High-Grade Myeloid Neoplasms","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (per the World Health Organization \\[WHO\\] 2016 classification) or high-grade myeloid neoplasm (\\>= 10% myeloid blasts in peripheral blood or marrow as assessed by morphology or multiparameter flow cytometry at initial presentation). Patients with biphenotypic or mixed phenotype acute leukemia are eligible.\n* PHASE I:\n\n  * Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2017 guidelines\n  * Relapsed\u002Frefractory patients presenting for trial entry must require first or subsequent salvage therapy and have detectable blasts in peripheral blood or \\>= 5% blasts in bone marrow, as assessed by morphology or multiparameter flow cytometry; or extramedullary myeloid sarcoma, per European LeukemiaNet 2017 guidelines.\n  * These patients are only allowed in the phase 1 portion of the trial\n* PHASE II: Newly diagnosed patients presenting for trial entry must have adverse risk disease as per the European LeukemiaNet 2022 guidelines\n* Age \\>= 18 years\n* Aspartate transaminase (AST) and alanine transaminase (ALT) =\\\u003C 3.0 X upper limit of normal (ULN)\n* Bilirubin =\\\u003C 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)\n* Subject must have adequate renal function as demonstrated by a creatinine clearance \\>= 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection\n* Left ventricular ejection fraction (LVEF) \\>= 45%, assessed by multigated acquisition (MUGA) or echocardiogram (ECHO) within 3 months prior to study day 0 or after most recent anthracycline administration if appropriate and no clinical evidence of congestive heart failure\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2\n* Treatment-related mortality (TRM) score \\\u003C 13.1\n* Female subjects of childbearing potential must have negative results for pregnancy test. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use an effective method of birth control from the time of signing the consent form until at least 3 months after the last dose of study drug\n* Ability to understand and the willingness to sign a written informed consent document\n* White blood cell count in peripheral blood must be \\\u003C 25,000\u002Ful prior to initiation of study therapy (CLAG-M plus venetoclax). Cytoreduction with hydroxyurea and\u002For cytarabine (e.g., 500 mg\u002Fm\\^2 per dose) is allowed to decrease the risk of tumor lysis syndrome\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia or chronic myeloid leukemia in myeloid blast crisis\n* Known active central nervous system (CNS) involvement with acute myeloid leukemia (AML)\n* Concomitant illness associated with a likely survival of \\\u003C 1 year\n* Active systemic infection, unless disease is under treatment with antimicrobials and considered controlled or stable; patients with fever thought to be likely secondary to leukemia are eligible. Patients with chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment would be excluded. 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 positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate\n* Known hypersensitivity to any study drug\n* Pregnancy or lactation because of the unknown risks of this combination\n* Concurrent treatment with any other investigational agent\n* Subject is known to be positive for human immunodeficiency virus (HIV)\n* Subjects who cannot discontinue concomitant CYP3A inhibitors, except for voriconazole, prior to cycle 1 day 1 (C1D1)\n* Treatment with any of the following within 7 days prior to the first dose of venetoclax\n\n  * Steroid therapy for anti-neoplastic intent\n* Administration or consumption of any of the following within 3 days prior to the first dose of venetoclax:\n\n  * Grapefruit or grapefruit products\n  * Seville oranges (including marmalade containing Seville oranges)\n  * Star fruit",{"count":50,"type":20},62,[52,53],"PHASE1","PHASE2","This phase I\u002FII trial finds the best dose, side effects and how well giving venetoclax in combination with cladribine, cytarabine, granulocyte colony-stimulating factor, and mitoxantrone (CLAG-M) in treating patients with acute myeloid leukemia and high-grade myeloid neoplasms. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Chemotherapy drugs, such as cladribine, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax with CLAG-M may kill more cancer cells.",[56,27,57,28,58,59,60,61,62,63,64,65,66],"Acute Biphenotypic Leukemia","Mixed Phenotype Acute Leukemia","Relapsed Acute Biphenotypic Leukemia","Relapsed Acute Myeloid Leukemia","Relapsed Mixed Phenotype Acute Leukemia","Relapsed Myeloid Neoplasm","Refractory Acute Biphenotypic Leukemia","Refractory Acute Myeloid Leukemia","Refractory Mixed Phenotype Acute Leukemia","Refractory Myeloid Neoplasm","Recurrent Myeloid Sarcoma","2026-04-14",{"date":69,"type":33},"2026-04-17",{"date":71,"type":33},"2022-02-04",{"date":73,"type":20},"2028-12-31",{"name":75,"class":40},"University of Washington",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":41},"100437864","a-randomized-trial-of-a-mobile-health-exercise-intervention-for-older-adults-with-myeloid-neoplasms-100437864","NCT04981821","A Randomized Trial of a Mobile Health Exercise Intervention for Older Adults With Myeloid Neoplasms","A Pilot Randomized Trial of a Mobile Health Exercise Intervention for Older Patients With Myeloid Neoplasms","GO-EXCAP2","Inclusion Criteria:\n\n* Age ≥60 years (conventional definition of older age in clinical trials of MN)\n* Have a diagnosis of MN\n* Planned for or receiving outpatient cancer-directed treatments (participants receiving consolidative or maintenance outpatient therapies after induction chemotherapy are allowed to enroll)\n* English speaking\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-3\n* No medical contraindications for exercise per oncologist\n* Able to walk 4 meters as part of Short Physical Performance Battery measured walk (with or without assistive device)\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Physical, psychological, or social impairments that would interfere with subject's ability to participate in the study or participate in the intervention, as determined by the PI or the treating team","60 Years",{"count":86,"type":20},170,[23],"This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with MN receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.",[90,28],"Cancer",[92,28,93],"mobile health exercise intervention","GO-EXCAP","2026-03-29",{"date":96,"type":33},"2026-04-03",{"date":98,"type":33},"2022-01-03",{"date":100,"type":20},"2026-12-31",{"name":102,"class":40},"University of Rochester",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":122,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":133},"100500462","phase-2-a-pilot-study-to-evaluate-the-feasibility-of-post-hematopoietic-stem-cell-transplant-prophylaxis-with-decitabine-combined-with-filgrastim-for-children-and-young-adults-with-aml-mds-and-related-myeloid-malignancies-100500462","NCT05796570","A Pilot Study to Evaluate the Feasibility of Post-Hematopoietic Stem Cell Transplant Prophylaxis With Decitabine Combined With Filgrastim for Children and Young Adults With AML, MDS and Related Myeloid Malignancies","MORE","Inclusion Criteria:\n\n* Disease Criteria: Participants must have a histologically confirmed diagnosis of one of the following hematologic malignancies for eligibility, as defined by the criteria below:\n\n  * AML (relapsed, de-novo or secondary) based on WHO classification\n  * MDS (relapsed, de-novo or secondary) based on WHO classification\n  * Treatment myeloid neoplasm (tMDS\u002FAML; relapsed disease included)\n  * Myeloid Sarcoma\n  * Acute Undifferentiated Leukemia (MPAL and acute leukemia of ambiguous lineage\u002FNOS not eligible)\n* Note: MDS, AML, MDS\u002FAML, or tMDS\u002FAML as defined above may be idiopathic\u002Fde novo or derived from a germline predisposition to myeloid malignancy. For patients with an underlying germline disorder, those conditions that are not associated with increased risk for toxicity to treatment, including patients with known germline ANKRD26, DDX41, ELANE and other congenital neutropenia disorders, ETV6, GATA-2, Li-Fraumeni, RUNX1, SAMD9\u002FSAMD9L, or Shwachman-Diamond Syndrome, will be analyzed within the general treatment cohort (Cohort A, see Table 1) along with patients with idiopathic disease (Cohort B, see Table 2).\n\nMDS, AML, MDS\u002FAML, or tMDS\u002FAML derived from the following germline disorders will be enrolled in a separate cohort (B) and adverse events monitored closely for higher rates compared to cohort A:\n\n* Dyskeratosis Congenita or associated telomeropathies as defined by telomere length \\\u003C1st percentile on 3 out of 4 lymphocyte subsets and\u002For corresponding pathogenic genetic mutation.\n* Fanconi Anemia as defined by positive chromosomal breakage test to DEB\u002FMMC and\u002For corresponding pathogenic genetic mutation.\n* Nijmegen Breakage Syndrome as defined by positive chromosomal breakage test to DEB\u002FMMC and\u002For corresponding pathogenic genetic mutation\n* ERCC6L2 by genomic testing.\n\nTable 2: Overview Inherited Bone Marrow Failure syndromes (iBMF)\n\n-iBMF with Standard risk for Treatment Related toxicities:\n\n* germline mutations in ANKRD26\n* germline mutations in DDX41\n* ELANE and other Congenital Neutropenia Disorders\n* germline mutations in ETV6\n* germline mutations in GATA-2\n* Li-Fraumeni\n* germline mutations in RUNX1\n* SAMD9\u002FSAMD9L\n* Shwachman-Diamond Syndrome\n* Familial MDS with thrombocytopenia\n* Diamond-Blackfan Anemia\n\nTable 2: Overview Inherited Bone Marrow Failure syndromes (iBMF)\n\n* iBMF with Increased Risk for Treatment Related Toxicities:\n\n  * Fanconi Anemia\n  * Dyskeratosis Congenita and associated Telomere Disorders\n  * Nijmegen Breakage Syndrome\n  * ERCC6L2\n* Patients must be receiving an allogeneic hematopoietic stem cell transplant. All donor types and graft sources are permitted. All conditioning regimens are permitted. All GVHD prophylaxis regimens are permitted.\n* Timing of Enrollment: Registration can occur from day - 40 to day - 1 prior to stem cell infusion.\n* Disease Status: Study enrollment will occur pre HCT. Any disease status is acceptable at the time of enrollment; however, patients must be in a MRD negative remission (as defined by multidimensional flow cytometry (MDF) post HCT prior to protocol treatment start). Post HCT\u002F pretreatment disease status will be performed by Hematologics.\n* No limitations on prior therapy.\n* Age ≥1 year and ≤ 39 year of age.\n* ECOG performance status ≤2 (Lansky, Karnofsky ≥60%).\n* Participants must have adequate organ function to be eligible for allogenic HCT as per institutional standard.\n* Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Anti- retroviral therapy must not have a non-acceptable drug interaction with protocol treatment.\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Suppressive therapy must not have a non-acceptable drug interaction with protocol treatment.\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. Ongoing antiviral therapy must not have a non-acceptable drug interaction with protocol treatment.\n* Participants with a malignancy in remission are eligible for this trial.\n* Participants with known history or current symptoms of cardiac disease should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.\n* The effects of filgrastim on the developing human fetus are unknown. For this reason and because decitabine is known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 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 decitabine administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 2) except for bone marrow suppression.\n* Participants should not be enrolled on another study that prohibits initiation of maintenance therapy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or filgrastim.\n* Participants with uncontrolled intercurrent illness.\n* Participant who are not able to present for clinic visits for at least 7 months after study treatment initiation.\n* Participant with FLT3\u002FITD mutations are excluded as maintenance therapy with tyrosine kinase therapy should be considered in this context. However, if a participant has a co-occurring NUP28 mutation, they will be considered eligible.\n* Participants with a concurrent active malignancy are not eligible for this trial.","1 Year","39 Years",{"count":113,"type":20},37,[53],"The purpose of this study is to examine if it is feasible to administer decitabine and filgrastim after allogenic hematopoietic stem cell transplant (HCT) in children and young adults with myelodysplastic syndrome, acute myeloid leukemia and related myeloid disorders, and if the treatment is effective in preventing relapse after HCT.\n\nThe names of the study drugs involved in this study are:\n\n* Decitabine (a nucleoside metabolic inhibitor)\n* Filgrastim (a recombinant granulocyte colony-stimulating factor (G-CSF)",[27,117,118,119,120,28,121],"Myelodysplastic Syndromes","Myeloid Malignancies","MDS","Inherited Bone Marrow Failure Syndrome","Aml",[27,117,118,119,120,28,123],"AML","2026-03-17",{"date":126,"type":33},"2026-03-19",{"date":128,"type":33},"2023-04-19",{"date":130,"type":20},"2029-09-01",{"name":132,"class":40},"Franziska Wachter",2,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":41},"100570682","evaluating-the-effects-of-hemoglobin-threshold-specific-packed-red-blood-cell-transfusions-on-quality-of-life-and-functional-outcomes-in-patients-with-high-grade-myeloid-neoplasms-acute-myeloid-leukemia-or-b-acute-lymphoblastic-lymphomaleukemia-100570682","NCT06710418","Evaluating the Effects of Hemoglobin Threshold-specific Packed Red Blood Cell Transfusions on Quality of Life and Functional Outcomes in Patients With High-grade Myeloid Neoplasms, Acute Myeloid Leukemia, or B Acute Lymphoblastic Lymphoma\u002FLeukemia","Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of \"high-grade\" myeloid neoplasm (≥ 10% blasts in blood or bone marrow) or acute myeloid leukemia (AML) (other than acute promyelocytic leukemia \\[APL\\]) or B-cell acute lymphoblastic lymphoma\u002Fleukemia (ALL) according to the 2022 WHO classification. Outside diagnostic material is acceptable to establish diagnosis\n* Plan to undergo intensive chemotherapy induction or post-remission therapy for their diagnosis (defined as \"7+3,\" hyper-cyclophosphamide, vincristine, doxorubicin, and dexamethasone \\[CVAD\\], or regimen with cytarabine backbone ≥ 1,000mg\u002Fm\\^2), or allogeneic HSCT, expected to induce anemia requiring PRBC transfusion AND platelet counts of ≤ 30,000\u002FuL for ≥ 5 days following the therapy (as determined by principal investigator)\n* Plan to get all post-chemotherapy\u002Fpost-HSCT care at the University of Washington (UW)\u002FFred Hutchinson Cancer Center (FHCC)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients requiring a prophylactic platelet transfusion at thresholds \\> 10,000\u002FuL\n* Patients requiring systemic anticoagulation, anti-platelet agent, or antifibrinolytic therapy that will not be held once platelets reach a level of \\\u003C 50,000\u002FuL\n* Patients with grade ≥ 2 bleeding (as determined by the WHO Bleeding Criteria) at the time of randomization\n* Arterial or venous thrombotic event, including myocardial infarction within 6 months prior to initiation of the chemotherapy\u002FHSCT\n* Patients requiring renal replacement therapy at the time of randomization\n* Patients who decline transfusion for personal or religious beliefs\n* Pregnancy or lactation",{"count":19,"type":20},[23],"This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma\u002Fleukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and\u002For anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the \"minimum\" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (\\> 7 gm\u002FdL) compared to a more liberal hemoglobin threshold (\\> 9 gm\u002FdL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.",[27,145,146,28],"B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","2026-02-09",{"date":149,"type":33},"2026-02-12",{"date":151,"type":33},"2025-10-15",{"date":153,"type":20},"2027-12-31",{"name":75,"class":40},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":41},"100441709","phase-2-two-step-haplo-with-radiation-conditioning-100441709","NCT05031897","Two Step Haplo With Radiation Conditioning","A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning","Inclusion Criteria:\n\n* Radiation-based cohort diagnoses:\n\n  * Acute myeloid leukemia\n  * Acute lymphoid leukemia in remission\n  * Myelodysplasia (MDS)\n  * Chronic lymphocytic leukemia (CLL) with no or minimal lymph node involvement\n  * Multiple myeloma\n  * Chronic myeloid leukemia\n  * Myelofibrosis\n  * Myeloid malignancy not otherwise specified\n  * Chronic myelomonocytic leukemia\n  * Essential thrombocytopenia or polycythemia vera\n  * T cell leukemia\n  * T cell lymphoma without significant lymph node disease burden\n  * Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable\n  * Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history. Examples are patients with previous treatment with radiation therapy precluding total-body irradiation (TBI), or a past history of myeloablative therapy, precluding a 2nd myeloablative regimen.\n  * Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)\n* Chemotherapy-based cohort diagnoses:\n\n  * Hodgkin or non-Hodgkin lymphoma\n  * Small lymphocytic lymphoma\u002FCLL\n  * Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease\n  * Hematological malignancy in patients who cannot receive \\> 2 Gy radiation\n  * Aplastic anemia and other non-malignant hematologic dyscrasias\n  * Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)\n* Human leukocyte antigen (HLA) identical cohort diagnoses:\n\n  \\* Patients in this group will be treated in parallel to the radiation-based cohort or the chemotherapy-based group based on what category their diagnosis falls into. However, these patients will have HLA identical related donors (one-antigen cross-over event included).\n* Left ventricular ejection fraction of \\>= 50%\n* Diffusion lung capacity of oxygen \\>= 50% and forced expiratory volume at 1 second \\>= 50% of predicted corrected for hemoglobin\n* Serum bilirubin =\\\u003C 1.8\n* Aspartate aminotransferase or alanine aminotransferase =\\\u003C 2.5 x upper limit of normal\n* Creatinine clearance of \\>= 60 mL\u002Fmin\n* Patients must have adequate Karnofsky performance status (KPS) and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) scores:\n\n  * Patients \\\u003C age 60 years must have a KPS of \\>= 60% and an HCT-CI score of 5 or less\n  * Patients aged 60 to 65 years must have a KPS of \\>= 60% and an HCT-CI score of 4 or less\n  * Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less\n  * Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less\n  * (Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator (PI) and at least 1 co-investigator (CI) not on the primary care team of the patient). This is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than guideline HCT-CI points. An example is a patient with a solid tumor malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities\n* Patients must be willing to use contraception if they have childbearing potential\n* Patient or patient's guardian is able to give informed consent\n* Patients should have a life expectancy of \\>= 6 months for reasons other than their underlying hematologic\u002Foncologic disorder\n* Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol\n* Patients should not be:\n\n  * Human immunodeficiency virus positive\n  * Have active involvement of the central nervous system with malignancy. This can be documented by a normal neurological exam, magnetic resonance imaging (MRI) of the head, and\u002For a negative cerebral spinal fluid analysis\n* Pregnant or breastfeeding",{"count":163,"type":20},63,[53],"This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.",[167,27,168,169,170,171,172,173,174,175,176,177,178,28,179,180,181],"Acute Lymphoblastic Leukemia","Adult T-Cell Leukemia\u002FLymphoma","Aplastic Anemia","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia, BCR-ABL1 Positive","Chronic Myelomonocytic Leukemia","Essential Thrombocythemia","Hematopoietic and Lymphatic System Neoplasm","Hodgkin Lymphoma","Multiple Myeloma","Myelodysplastic Syndrome","Myelofibrosis","Non-Hodgkin Lymphoma","Polycythemia Vera","Small Lymphocytic Lymphoma","2025-10-28",{"date":184,"type":33},"2025-10-30",{"date":186,"type":33},"2021-10-25",{"date":188,"type":20},"2032-04",{"name":190,"class":40},"Thomas Jefferson University",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":201,"phases":4,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":41},"100444967","the-myeloid-neoplasms-biology-and-outcome-project-100444967","NCT05074316","The Myeloid Neoplasms Biology and Outcome Project","A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Patients With Myeloid Neoplasms","MyBOP","Inclusion Criteria:\n\n* Suspected or proven diagnosis of Myeloid Neoplasms according to the WHO Classification of Tumors of Haematopoietic and Lymphoid Tissues\n* Age ≥18 years\n* Ability to understand the nature and individual consequences of the registry\n* Written informed consent\n* Subjects who are physically or mentally capable of giving consent\n\nExclusion Criteria:\n\nSevere neurological or psychiatric disorder interfering with the ability to give written informed consent",{"count":200,"type":20},1000,"OBSERVATIONAL","The Myeloid Neoplasms Biology and Outcome Project (MyBOP) aims to establish a registry study for patients with myeloid neoplasms. It integrates clinical data, biological samples, socio-demographic information, long-term follow-up and patient reported outcomes in a structured manner for scientific purposes.\n\nThe ultimate benefits are:\n\n1. Improvement of evidence-based clinical management of patients with myeloid neoplasms through better understanding of the course of disease and prognostic and predictive parameters\n2. Direct access to new and personalized treatment approaches through recruitment into clinical studies based on the myeloid neoplasms study platform\n3. Quality assurance of participating centers by evaluating and comparing clinical outcomes and side effects of the MyBOP patients with published data.",[28],[205,206],"outcome project","registry","2025-03-24",{"date":209,"type":33},"2025-03-25",{"date":211,"type":33},"2020-03-10",{"date":213,"type":20},"2032-12-31",{"name":215,"class":40},"University Hospital Heidelberg"]