[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myelogenous-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myelogenous-leukemia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,60,88,117,145,167,191,215,270,312,342],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":43,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100526212","pharmacokinetic-study-of-venetoclax-tablets-crushed-and-dissolved-into-a-solution-100526212",false,"NCT06131801","Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution","A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\n* Age: Patients must be \\\u003C39 years of age at time of study enrollment\n* Diagnosis: Patients may have a diagnosis of any hematologic malignancy\n* Central access: Patients must have an existing venous or arterial access line for PK blood draws\n* Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment\n* Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.\n* Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.\n* Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.","ALL","0 Years","38 Years",{"count":20,"type":21},30,"ESTIMATED","OBSERVATIONAL","The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown.\n\nPrimary Objectives\n\n• To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution\n\nSecondary Objectives\n\n* To evaluate the safety of crushed venetoclax tablets administered as an oral solution\n* To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors\n* To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie. PO vs NG tube vs G-tube)\n* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution",[25,26,27,28,16,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"Hematologic Malignancy","Leukemia","Lymphoma","Acute Lymphocytic Leukemia","Acute Myelogenous Leukemia","AML","Chronic Myelogenous Leukemia","CML","Myeloproliferative Neoplasm","Non Hodgkin Lymphoma","Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma","Follicular Lymphoma","Burkitt Lymphoma","T-cell Lymphoma","B Cell Lymphoma","Peripheral T Cell Lymphoma","Cutaneous B-Cell Lymphoma",[44,45,46],"Venetoclax","Pediatric AML","Pediatric Relapsed\u002FRefractory AML","RECRUITING","2026-06-02",{"date":50,"type":51},"2026-06-04","ACTUAL",{"date":53,"type":51},"2023-11-15",{"date":55,"type":21},"2027-12-01",{"name":57,"class":58},"Children's Hospital Medical Center, Cincinnati","OTHER",5,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":4,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100639057","phase-1-adapt-nk-for-high-risk-myeloid-diseases-as-bridge-to-allo-hsct-100639057","NCT07591649","Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT","Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 18-74 years with Karnofsky score ≥ 70%\n* 75 years and older: KPS ≥ 70%, HCT-CI \\\u003C 5 (excluding history of solid tumor), AND not frail by Fried frailty criteria (see Appendix III)\n* HLA type C1\u002FC1 or C2\u002FC2\n\nNote: For easy determination, the definition of HLA-C ligand group assigments is included below:\n\nHLA-C1 group alleles are defined as HLA-C01, C03, C07, C08, C12, C14, C16 HLA-C2 group alleles are defined as HLA-C02, C04, C05, C06, C15, C17, C18\n\n* adequate liver, renal, pulmonary and cardiac function\n* ability to be off glucocorticoids and other immunosuppressive medications indicated for acute or chronic GVHD for at least 28 days prior to the AdaptNK cell infusion\n* There must be sufficient time between the most recent therapy and the screening bone marrow as delineated below:\n* anti-leukemic systemic cytotoxic chemotherapy - 2 weeks\n* Targeted anti-leukemic agents (FLT-3, IDH, menin inhibitors) - 3 half-lives of the medication\n* Radiotherapy - 1 week\n* donor lymphocyte infusions - 6 weeks\n* hematopoietic growth factors (filgrastim, TPO agonists, EPO) - 1 week\n* biologic therapy (monoclonal antibodies, T-cell engagers) - 2 weeks\n* Immune effector cellular therapy - 4 weeks\n* Intrathecal chemotherapy for treatment of active CNS leukemia - there must be at least two CSF samples negative for leukemia separated by one week before enrollment.\n* WBC shall be \\\u003C 25,000 before infusion. Hydroxyurea is permitted until day -3 to control excess blast proliferation. No other systemic treatment is allowed after the screening bone marrow is performed for inclusion in protocol\n* All prior treatment related toxicities should have resolved to ≤ grade 1 prior to study enrollment\n* agrees to use of adequate contraception from study enrollment to 4 months after cell infusion\n* voluntary written consent\n\nExclusion Criteria:\n\n* Myeloid neoplasms with known or strongly suspected germline background, except DDX41, TP53, or RUNX1.\n* Acute promyelocytic leukemia (APL)\n* myocardial infarction (MI) within previous 6 months of study enrollment\n* pregnant or breastfeeding\n* Active CNS involvement with AML\n* new or progressive pulmonary infiltrates\n* active autoimmune disease requiring immunosuppressive therapy\n* Preexisting inflammatory disease requiring immunosuppressive therapy\n* history of severe asthma and currently on chronic systemic medications\n* HIV-1\u002F2 positivity or hepatitis C\u002FB\n* active systemic infections requiring anti-infective treatment\n* received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)\n* Patients with second malignancies are excluded if they have required systemic cytotoxic chemotherapy within 1 year or if they are not in remission\n* Exception: patients that are on stable dosing of hormonal therapy (e.g. aromatase inhibitor or antiandrogen therapy) for active breast or prostate cancer for 1 year are eligible.\n* Patients with excised basal cell or squamous cell carcinoma of the skin are eligible.\n* Patients with excised carcinoma in situ of the cervix or breast are eligible.\n* Patients with untreated T1a or T1b prostate cancer are eligible.","18 Years",{"count":69,"type":21},18,"INTERVENTIONAL",[72,73],"PHASE1","PHASE2","This is a multi-institutional Phase I\u002FII study of an allogeneic KIR-HLA mismatched NK cell infusion (AdaptNK) and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy \\[cyclophosphamide (CY)\u002Ffludarabine (FLU)\\] in patients with relapsed or refractory acute myelogenous leukemia (AML). AdaptNK is a natural killer (NK) cell product that is enriched for NK cells with an \"adaptive\", or human cytomegalovirus (CMV)-induced, phenotype.",[76,77,29],"Relapsed Adult AML","Refractory AML","2026-05-15",{"date":80,"type":51},"2026-05-19",{"date":82,"type":51},"2026-05-08",{"date":84,"type":21},"2035-03-01",{"name":86,"class":58},"Masonic Cancer Center, University of Minnesota",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":70,"phases":98,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":87},"100636491","phase-2-cord-blood-transplantation-in-children-and-young-adults-with-blood-cancer-100636491","NCT07566377","Cord Blood Transplantation in Children and Young Adults With Blood Cancer","Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies","Inclusion Criteria:\n\nA patient cannot be considered eligible for this study unless ALL of the following conditions are met.\n\n° Disease type\n\nCohort 1, High Risk Disease: Patients with age ≤ 26 years at the time of informed consent with no available and suitably matched related or unrelated donor within 4 weeks, with one of the following diagnoses:\n\nI. Acute myelogenous leukemia (AML):\n\n* Complete first remission (CR1) with blast count \\\u003C 5% by bone marrow morphology at high risk for relapse such as any of the following:\n\n  * Known prior diagnosis of myelodysplasia (MDS)\n  * High risk cytogenetics (e.g., those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) and\u002For high-risk molecular abnormalities (e.g., TP53)\n  * Requirement for 2 or more inductions to achieve CR1\n  * Therapy-related AML (t-AML) or therapy-related myeloid neoplasm (t-MN) (including after therapy for other malignancy, and\u002For gene therapy or cell therapy)\n  * Presence of Minimal\u002FMeasurable Residual Disease (MRD+) by cytogenetics, flow cytometry or molecular methods (at End of Induction or End of Consolidation)\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or subsequent remission, with blast count \\\u003C 5% by bone marrow morphology\n* Presence of MRD by multiparameter flow cytometry at pre-transplant evaluation is acceptable.\n\nII. Acute lymphoblastic leukemia (ALL):\n\n* Complete first remission (CR1) with MRD negative status by multicolor flow cytometry, at high risk for relapse such as any of the following:\n\n  * Presence of any high risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other, KMT2A (11q23) or other high risk molecular abnormality\n  * Failure to achieve complete remission (CR) after four weeks of induction therapy (transplant to follow antibody therapy and\u002For CAR T cells)\n  * Persistence or recurrence of MRD on therapy (Transplant to follow antibody therapy and\u002For CAR T cells)\n  * T-ALL in CR even with presence of MRD\n  * Other high-risk features not defined above\n* Complete second remission (CR2) or subsequent remission with MRD negative status by multiparameter flow cytometry.\n\n  * Relapse in less than 36 months from CR1\n  * Relapse for T-ALL\n* Patients after antibody therapy (e.g., blinatumomab, inotuzumab, other) and\u002For CAR-T cell therapy that resulted in MRD negative status by multiparameter flow cytometry.\n\nIII. Other acute leukemias:\n\n* Leukemias of ambiguous lineage or of other types with \\\u003C 5% blasts by bone marrow morphology.\n* Patients with persistent\u002Frelapsed disease with cytogenetic, flow cytometric or molecular aberrations in \\\u003C 5% of cells.\n* Chronic myelogenous leukemia: Patients with history of blast crisis or accelerated phase.\n* Any leukemia that developed after gene therapy or cell therapy\n\nIV. Myelodysplastic Syndrome (MDS):\n\n* Any IPSS risk category with life-threatening cytopenia(s).\n* Any IPSS risk category with high risk cytogenetic\u002Fmolecular findings (5, 7, 8, complex karyotype, or TP53)\n\nV. Non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) at high risk of relapse or progression if not in remission:\n\n* Patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell NHL) in CR.\n* Patients with indolent B cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with stable disease\u002F CR\u002F PR with no single lesion equal to or more than 5 cm.\n* Patients with HL without progression of disease (POD) after salvage chemotherapy with no single lesion ≥5 cm.\n\nCohort 2: Very High-Risk disease:\n\n1. Patients in CR (bone marrow blasts \\\u003C5% by morphology) who had prior allogeneic transplant and disease recurrence. The second transplant will take place at least 4 months after the first.\n\n   * Acute myelogenous leukemia (AML) or Myelodysplastic Syndrome (MDS): Relapse after previous transplant, in CR after induction therapy. MRD positive status by multi-parameter flow cytometry is accepted.\n   * Acute lymphoblastic leukemia (ALL): Relapse after previous transplant, in CR after induction therapy and\u002For antibody therapy\u002FCAR T cells. MRD positive status after targeted therapy, as evaluated by multi-parameter flow cytometry is accepted.\n   * Other: patients with leukemia or lymphoma, who, in the opinion of their physician, are not likely to have reduction in disease burden with further chemotherapy.\n2. Patients with relapsed\u002Frefractory disease at either first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology. ° Relapse after previous transplant with \\\u003C 30% blasts by bone marrow morphology, or with cytogenetic, flow cytometric, or molecular abnormalities in \\\u003C 30% of bone marrow cells, after induction therapy.\n\n   ° Primary refractory or relapsed AML with \\\u003C 30% blasts by bone marrow morphology or with cytogenetic, flow cytometric, or molecular abnormalities in \\\u003C 30% of bone marrow cells.\n\n   ° Age 0-26 years at the time of informed consent\n\n   ° Performance: Karnofsky (≥16 years) or Lansky score (\\\u003C16 years) of ≥70% (see Appendix A).\n\n   ° Not Pregnant and Not Nursing\n\n   ° Required Organ Function\n   * Bilirubin ≤ 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia).\n   * ALT ≤ 3 x upper limit of normal.\n   * Pulmonary function (FVC, FEV1 and DLCO corrected for hemoglobin) ≥ 50% predicted.\n\n     * In young children unable to perform pulmonary function testing: pulse oximetry \\>92% in room air, and a normal CT of the chest (if CT is not normal, the child needs to be evaluated and cleared by pediatric pulmonary physician).\n   * Left ventricular ejection fraction \\> 50%.\n   * Age-adjusted Hematopoietic Cell Transplantation-Comorbidity Index (aaHCT-CI) ≤ 7.\n   * Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrolment and must be willing to use an effective contraceptive method while enrolled in the study.\n   * Renal: Serum creatinine (SCr) ≤ 1.5 x normal for age. If SCr is outside the normal range, then CrCl \\> 50 mL\u002Fmin (calculated or estimated) or estimated GFR (mL\u002Fmin\u002F1.73m2) \\>30% of predicted normal for age.\n\n   Normal GFR by Age : Mean GFR +- SD (mL\u002Fmin\u002F1.73m\\^2) 1 week : 40.6 + \u002F - 14.8 2-8 weeks : 65.8 + \u002F - 24.8 \\>8 weeks : 95.7 + \u002F - 21.7 2-12 years : 133.0 + \u002F - 27.0 13-21 years (males) : 140.0 + \u002F - 30.0 13-21 years (females) : 126.0 + \u002F - 22.0\n\n   GFR, glomerular filtration rate; SD, standard deviation; Greater than 2 years old: Normal GFR is 100 mL\u002F min; Infants: GFR must be corrected for body surface area.\n\n   Exclusion Criteria:\n\n   Exclusion criteria for both cohorts:\n\n   ° Inadequate performance status\u002F organ function.\n\n   ° Active CNS leukemic involvement.\n   * Chloroma \\>2 cm.\n   * Active and uncontrolled infection (bacterial\u002Ffungal\u002Fviral) at time of transplant.\n   * HIV infection.\n   * Seropositivity for HTLV-1.\n   * Pregnancy or breast feeding.\n   * Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.\n   * Any abnormal condition or lab result that is considered by the PI capable or altering patient's condition or study outcome.\n\n   Cohort 2 Very High-Risk Disease (additional to above):\n\n   ° Allogeneic HCT in the preceding 4 months.\n\n   Note (1): Prior checkpoint inhibitors\u002Fblockade in the last 12 months: eligibility to be discussed with study PI.\n\n   Note (2): For patients with known HBV and\u002For HCV infection :\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.","26 Years",{"count":97,"type":21},71,[73],"The purpose of this study is to find out whether Cord Blood Transplantation\u002FCBT as the first or second transplant is an effective treatment for children and young adults with blood cancer.",[29,101,102,103,35,26,27,104],"Acute Lymphoblastic Leukemia","Myelodysplastic Syndromes","Non-hodgkin Lymphoma","Graft-versus-host Disease",[106,104,27,26,35,103,102,101,29,107,108],"Cord blood transplants","Memorial Sloan Kettering Cancer Center","26-168","2026-05-11",{"date":111,"type":51},"2026-05-14",{"date":113,"type":51},"2026-04-28",{"date":115,"type":21},"2030-04-28",{"name":107,"class":58},{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":124,"enrollmentInfo":125,"targetDuration":127,"studyType":22,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":87},"100200817","the-prospective-collection-storage-and-reporting-of-data-on-patients-undergoing-hematopoietic-stem-cell-transplantation-utilizing-a-standard-preparative-regimen-100200817","NCT01890486","The Prospective Collection, Storage and Reporting of Data on Patients Undergoing Hematopoietic Stem Cell Transplantation Utilizing a Standard Preparative Regimen","The Prospective Collection, Storage and Reporting of Data on Patients","Inclusion Criteria:\n\nPlanned standard of care dose intensive therapy and either an allogeneic or autologous bone marrow transplant\n\nExclusion Criteria:\n\nParticipation in any other treatment research protocol","120 Years",{"count":126,"type":21},2000,"1 Year","To provide the IRB approved mechanism for the prospective collection and analysis on participants who are undergoing either an autologous or allogeneic hematopoietic stem cell transplant for a disease in which a research question is not being addressed.",[29,28,31,130,131,132,133,102,134,135],"Non-Hodgkin's Lymphoma","Hodgkin's Disease","Multiple Myeloma","Germ Cell Neoplasms","Chronic Lymphocytic Leukemia","Immunodeficiency Diseases","2026-04-09",{"date":138,"type":51},"2026-04-13",{"date":140,"type":51},"2001-05-21",{"date":142,"type":21},"2026-12",{"name":144,"class":58},"Wake Forest University Health Sciences",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":70,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":69},"100566539","phase-1-icp-248-in-combination-with-azacitidine-for-the-treatment-in-patients-with-myeloid-malignancies-100566539","NCT06656494","ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies","A Phase 1 Study of ICP-248 in Combination With Azacitidine for the Treatment in Patients With Myeloid Malignancies.","Inclusion Criteria:\n\nEligible subjects must meet all of the following criteria:\n\n1. Subject must have confirmation of diagnosis of AML (except for acute promyelocytic leukemia \\[APL\\]) or MDS per 2016 World Health Organization (WHO) criteria.\n2. For AML (except for APL) cohort:\n\n   1. Previously treated relapsed\u002Frefractory AML subjects\n   2. Treatment-naïve AML subjects should be: ≥60 years of age OR ≥18 years and \\\u003C60 years will be eligible if the subject has at least one of the following co-morbidities, which make the subject unfit for intensive chemotherapy\n3. For MDS cohort: Adult TN MDS and R\u002FR MDS: revised International Prognostic Scoring System (IPSS-R) score \\> 3 and bone marrow blasts ≥ 5%.\n4. Subject must have a projected life expectancy of at least 12 weeks.\n5. Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft-Gault formula.\n6. Subject must have adequate liver function\n\nExclusion Criteria:\n\n1. R\u002FR AML or R\u002FR MDS with no response or intolerance to post azacitidine or BCL-2i.\n2. Subject has acute promyelocytic leukemia (French-American-British Class M3 AML) .\n3. Subject has known central nervous system (CNS) leukemia.\n4. Suggest patients with active hepatitis B or C virus infection\n5. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.\n6. Subjects have another active malignancy within the past 2 years before study entry, except for curatively treated.",{"count":153,"type":21},266,[72],"Evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ICP-248 in combination with azacitidine in patients with acute myelogenous leukemia and Myelodysplastic Syndromes.",[29,157],"Myelodysplastic Syndromes (MDS)","2026-04-08",{"date":138,"type":51},{"date":161,"type":51},"2024-12-18",{"date":163,"type":21},"2028-01",{"name":165,"class":166},"Beijing InnoCare Pharma Tech Co., Ltd.","INDUSTRY",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":70,"phases":175,"briefSummary":176,"conditions":177,"keywords":179,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":87},"100585601","phase-2-co-transplant-of-an-unmodified-haplo-identical-graft-with-cord-blood-100585601","NCT06904482","Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood","Inclusion Criteria:\n\n* Participants with the following hematologic malignancies:\n\n  * Acute myelogenous leukemia (AML): High-risk AML including:\n\n    * Antecedent hematological disease (e.g., myelodysplasia (MDS))\n    * Treatment-related\n    * Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, TP53 mutations, complex cytogenetics)\n    * Participants must be in CR1, CR2, CR3 or CRi\n  * Acute lymphoblastic leukemia (ALL)\n\n    * High-risk CR1 including:\n\n      * Poor-risk cytogenetics (e.g., t(9;22)or 11q23 rearrangements)\n      * Presence of minimal disease by flow cytometry or PCR or Clonoseq after 2 or more cycles of chemotherapy\n      * No CR within 4 weeks of initial treatment\n    * Participants in CR2 or beyond\n    * Participants must be in CR1, CR2, CR3, or CRi\n  * Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system (IPSS-R) or treatment related MDS\n  * High-risk lymphoma\n* Age \\> 18 years\n* Participants without a suitable HLA-matched related or unrelated donor CASE9Z24 Page 17 Version dated 12.16.2025\n* Participants with the following suitable grafts:\n\n  * A 4-8\u002F8 HLA high resolution matched cord blood unit with a cell dose of 1.0x105 CD34 cells\u002Fkg.\n  * A haplo-identical donor with a goal cell dose of \\> 4.0x106 CD34cells\u002Fkg (minimum 2 x106 CD34 cells\u002Fkg)\n* Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia including standard intrathecal chemotherapy and\u002For radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Participants must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with inadequate Organ Function as defined by:\n\n  * Creatinine clearance \\\u003C 40ml\u002Fmin (Cockcroft-Gault)\n  * Bilirubin \\> 2X institutional upper limit of normal unless Gilbert syndrome\n  * AST (SGOT) \\> 3X institutional upper limit of normal\n  * ALT (SGPT) \\> 3X institutional upper limit of normal\n  * Pulmonary function: DLCOc \\\u003C 60%\n  * Cardiac: left ventricular ejection fraction \\\u003C 40%\n  * ECOG \\\u003C2\n* Participants with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.\n* Prior autologous stem cell transplant or CAR-T within the preceding 6 months or prior allogeneic transplant.",{"count":174,"type":21},36,[73],"The purpose of this study is to see if see if adding the specific combination of donors can result in acceptable levels of survival without evidence of disease.",[178,29,28,102],"aGVHD",[180,181],"Unmodified Haplo-Identical Graft with Cord Blood","post-transplant cyclophosphamide aGVHD prophylaxis","2026-02-25",{"date":184,"type":51},"2026-02-27",{"date":186,"type":51},"2025-08-13",{"date":188,"type":21},"2030-02-25",{"name":190,"class":58},"Case Comprehensive Cancer Center",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100514104","real-world-treatment-experience-of-patients-with-breast-lung-ovarian-multiple-myeloma-or-acute-myelogenous-leukemia-using-remote-symptom-monitoring-100514104","NCT05974150","Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring","Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia (AML) Using Remote Symptom Monitoring","Inclusion Criteria:\n\n* All participants must be 18 years of age or older.\n* Subjects may be any stage and anywhere in the treatment continuum.\n* Subject participants must have a diagnosis of a breast, lung, AML, ovarian cancer or multiple myeloma.\n* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.\n* All participants must be able to understand English.\n\nExclusion Criteria:\n\n* Any patient who cannot understand written or spoken English.\n* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.\n* Any patient on a treatment clinical trial.\n* Any prisoner and\u002For other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).",{"count":199,"type":21},25,"The goal of this study is to create a data set to add to Carevive's registry from real world clinical and patient reported data collected using an electronic care planning system (CPS) with remote symptom monitoring that is used in routine care for cancer patients on active treatment.\n\nPatients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic patient reported outcome (PRO) surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment.",[202,203,132,204,29],"Breast Cancer","Lung Cancer","Ovarian Cancer","2026-02-19",{"date":207,"type":51},"2026-02-23",{"date":209,"type":51},"2023-07-19",{"date":211,"type":21},"2026-12-31",{"name":213,"class":166},"Carevive Systems, Inc.",7,{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":70,"phases":224,"briefSummary":226,"conditions":227,"keywords":237,"overallStatus":260,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"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":223,"type":21},306,[73,225],"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.",[228,229,29,230,231,232,233,234,235,236,77],"Acute Leukemia","Myeloid Leukemia","Acute Myeloid Leukemia","Acute Myeloid Leukemia, in Relapse","Myelogenous Leukemia","Myelogenous Leukemia, Acute","Myelogenous Leukemia in Relapse","Transplant-Related Disorder","Allogeneic Disease",[230,26,238,239,240,241,77,242,243,244,245,246,247,248,249,250,251,252,253,254,255,256,257,258,259],"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","NOT_YET_RECRUITING","2025-09-04",{"date":263,"type":51},"2025-09-10",{"date":265,"type":21},"2026-01",{"date":267,"type":21},"2034-02",{"name":269,"class":166},"Actinium Pharmaceuticals",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":277,"enrollmentInfo":278,"targetDuration":4,"studyType":70,"phases":280,"briefSummary":281,"conditions":282,"keywords":294,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":87},"100501157","phase-2-allo-hsct-using-ric-and-ptcy-for-hematological-diseases-100501157","NCT05805605","Allo HSCT Using RIC and PTCy for Hematological Diseases","Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning (RIC) With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases","Inclusion Criteria:\n\n* Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\\\u003C 16 years).\n* 5\u002F6 or 6\u002F6 related donor, OR a 7-8\u002F8 HLA-A, B, C, DRB1 allele match, OR a haplotype (at least 5\u002F10) matched related donor. Donors will be requested to provide PBSCs although bone marrow is acceptable according to donor preference.\n\nEligible Diseases Acute Leukemias: Must be in remission by morphology (≤5% blasts) AND without evidence of MRD by flow cytometry, FISH, or conventional cytogenetics. PCR based MRD detection is not an exclusion to proceed.\n\nAcute Myeloid Leukemia (AML) and related precursor neoplasms:\n\n2nd or greater complete remission (CR); first complete remission (CR1) in patients \\> 60 years old; CR1 in ≤ 60 years old that is NOT considered as favorable-risk.\n\nFavorable risk AML is defined as having one of the following:\n\n* t(8,21) without cKIT mutation\n* inv(16) or t(16;16) without cKIT mutation\n* Normal karyotype with mutated NPM1 and wild type FLT-ITD (unless persistently NPM1 positive by PCR following two cycles of chemotherapy)\n* Normal karyotype with double mutated CEBPA\n* Acute prolymphocytic leukemia (APL) in first molecular remission at the end of consolidation\n\nAcute lymphoblastic Leukemia (ALL) \u002Flymphoma:\n\nCR2 or greater, CR1 unable to tolerate consolidation chemotherapy due to chemotherapy-related toxicities; CR1 high-risk ALL.\n\nHigh risk ALL is defined as having one of the following:\n\n* Evidence of high risk cytogenetics, e.g. t(9;22), t(1;19), t(4;11), other MLL rearrangements, IKZF1\n* 30 years of age or older at diagnosis\n* White blood cell counts of greater than 30,000\u002FmcL (B-ALL) or greater than 100,000\u002FmcL (T-ALL) at diagnosis\n* CNS leukemia involvement during the course of disease\n* Slow cytologic response (\\>10% lymphoblasts in bone marrow on Day 14 of induction therapy)\n* Evidence of persistent immonophenotypic or molecular minimal residual disease (MRD) at the end of induction and consolidation therapy.\n\nVery high risk pediatric patients with ALL:\n\npatients \\\u003C21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.\n\nBiphenotypic\u002FUndifferentiated\u002FProlymphocytic Leukemias in first or subsequent CR.\n\nChronic Myelogenous Leukemia in chronic or accelerated phase, or CML blast crisis in morphological remission (\\\u003C5% blasts) and with negative MRD by flow cytometry (a positive PCR for BCRABL is acceptable for BMT): Chronic phase patients must have failed at least two different TKIs, been intolerant to all available TKIs or have T315I mutation. Patients with CML blast crisis in CR are only eligible if there is an feasible TKI maintenance plan following BMT.\n\nPlasma Cell Leukemia after initial therapy, who achieved at least a partial remission; or relapsed and achieved subsequent remission (CR\u002FPR) Myelodysplastic Syndrome: IPSS INT-2 or High Risk; R-IPSS High or Very High; WHO classification: RAEB-1, RAEB-2; Severe Cytopenias: ANC \\\u003C 0.8, Anemia or thrombocytopenia requiring transfusion; Poor or very poor risk cytogenetics based on IPSS or R-IPSS definitions; therapy-related MDS. Blasts must be \\\u003C 5% by bone marrow aspirate morphology. If ≥5% blasts, patient requires chemotherapy for cytoreduction to \\\u003C5% blasts prior to transplantation Leukemia or MDS in aplasia. These patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease ≥ 28 days post-therapy. These high risk patients will be analyzed separately.\n\nBurkitt's Lymphoma in CR2 or subsequent CR. Relapsed T-Cell Lymphoma that is chemotherapy sensitive in CR\u002FPR that has failed or ineligible for an autologous transplantNatural Killer Cell Malignancies. Relapsed Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma which have progressed within 12 months of achieving a partial or complete remission. Patients who had remissions lasting \\> 12 months, are eligible after at least two prior therapies. Patients with bulky disease should be considered for de-bulking chemotherapy before transplant. Patients with refractory disease may be eligible, unless bulky disease and an estimated tumor doubling time of less than one month.\n\nLymphoplasmacytic Lymphoma, Mantle-Cell Lymphomais eligible after initial therapy if chemotherapy sensitive.\n\nLarge Cell and other high risk NHL \\> CR2\u002F\\> PR2: Patients in CR2\u002FPR2 with initial short remission (\\\u003C6 months) are eligible.\n\nRelapsed Multiple Myeloma: that is chemotherapy sensitive and has failed or ineligible for an autologous transplant.\n\nMyeloproliferative Neoplasms\u002FMyelofibrosis - with transfusion dependence or expected survival under 5 years by DIPSS, DIPSS-plus, or MPSS70 calculator.\n\nAcquired Bone Marrow Failure Syndromes except for Fanconi anemia Other Leukemia Subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy. This effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes. Therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee.\n\nAdditional Criteria for Bulky Disease (lymphomas) if stable disease is best response, the largest residual nodal mass must \\\u003C 5 cm (approximately) If response to previous therapy, the largest residual mass must represent a 50% reduction and be \\\u003C 7.5 cm (approximately)\n\nOrgan Function Criteria\n\nAdequate organ function is defined as:\n\nLiver: Transaminases ≤ 5 x upper limit of normal (ULN) and total bilirubin ≤ 2.5 mg\u002FdL except for patients with Gilbert's syndrome or hemolysis.\n\nRenal: A normal creatinine (adults) or creatinine clearance ≥ 40 mL\u002Fmin (pediatrics). Adults with a creatinine \\> 1.2 mg\u002Fdl or a history of renal dysfunction must have estimated GFR ≥ 40 ml\u002Fmin\u002F1.73m2.\n\nCardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction \\> 40%. For children that are not able to cooperate with MUGA and echocardiography, such should be clearly stated in the physician's note.\n\nPulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.\n\nIf recent confirmed mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease HIV infection with undetectable viral load. All HIV+ patients must be evaluated by Infectious Disease (ID) and a HIV management plan establish prior to transplantation Sexually active females of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control during study treatment Voluntary written consent (adult or parent\u002Fguardian with presentation of the minor information sheet, if appropriate)\n\nRelated donors will be evaluated and collected according to UMN BMT program standard processes. Unrelated donors will be identified and collected through the National Marrow and Donor Program (NMDP) per usual steps.\n\nExclusion Criteria:\n\n* Pregnant or breast feeding. The agents used in this study include Pregnancy Category D: known to cause harm to a fetus. Females of childbearing potential must have a negative pregnancy test prior to starting therapy.\n* Untreated active infection\n* Active central nervous system malignancy\n* CML in blast crisis\n* Intermediate or high grade NHL, mantle cell NHL, and Hodgkin disease that is progressive on salvage therapy. Stable disease is acceptable to move forward provided it is non-bulky.\n* Less than 3 months since prior myeloablative transplant\n* Evidence of progressive disease by imaging modalities or biopsy - persistent PET activity, though possibly related to lymphoma, is not an exclusion criterion in the absence of CT changes indicating progression.","75 Years",{"count":279,"type":21},56,[73],"This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide\u002F fludarabine\u002Ftotal body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis.",[29,28,283,284,285,31,286,102,287,288,38,289,290,291,292,37,33,293],"Biphenotypic Acute Leukemia","Undifferentiated Leukemia","Prolymphocytic Leukemia","Plasma Cell Leukemia","Leukemia, Myeloid","Myelodysplastic Syndrome With Excess Blasts-1","Relapsed T-Cell Lymphoma","Relapsed Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Marginal Zone Lymphoma","Myelofibrosis",[295,296,297,30,32,298,299,300,301,302,303,16],"MDS","CLL","SLL","PFS","TRM","GVHD","MMF","TBI","PTCy","2025-06-27",{"date":306,"type":51},"2025-07-01",{"date":308,"type":51},"2023-05-01",{"date":310,"type":21},"2028-10-22",{"name":86,"class":58},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":67,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":70,"phases":322,"briefSummary":323,"conditions":324,"keywords":328,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":87},"100568395","phase-2-abba-cord-dcbt-w-abatacept-for-agvhd-prophylaxis-100568395","NCT06680661","ABBA CORD: dCBT w\u002F Abatacept for aGVHD Prophylaxis","ABBA CORD: Double Umbilical Cord Blood Transplants With Abatacept for Graft Versus Host Disease Prophylaxis","Inclusion Criteria:\n\n* Patients with the following hematologic malignancies:\n\n  * Acute myelogenous leukemia (AML): High-risk and intermediate-risk AML including:\n\n    * Antecedent hematological disease (e.g., myelodysplasia (MDS))\n    * Treatment-related leukemia\n    * Complete Remission (CR1) with poor or intermediate-risk cytogenetics or molecular markers (e.g. Flt 3 mutation, 11q23, del 5, del 7, complex cytogenetics)\n    * CR2 or CR3\n    * Induction failure or 1st relapse with \\\u003C 10% blasts in the marrow\n  * Acute lymphoblastic leukemia (ALL):\n\n    * High-risk CR1 including:\n\n      * Poor-risk cytogenetics (e.g., Philadelphia chromosome t(9;22)or 11q23 rearrangements)\n      * Philadelphia chromosome-like ALL\n      * Presence of minimal disease by flow cytometry after 2 or more cycles of chemotherapy\n    * No CR within 4 weeks of initial treatment\n    * Induction failure with \\\u003C 10% blasts in the marrow\n    * CR2 or CR3\n  * Myelodysplastic syndromes (MDS), Intermediate, High or Very High Risk by the revised international prognostic scoring system or treatment related MDS.\n  * Bi-phenotypic or mixed-phenotypic acute leukemia in:\n\n    * CR.\n    * Induction failure or 1st relapse with \\\u003C 10% blasts in the marrow.\n  * Chronic Myelogenous Leukemia (CML) in second chronic phase after accelerated or blast crisis.\n  * Chronic Myelomonocytic Leukemia (CMML)\n  * Hodgkin's Lymphoma that is relapsed or refractory\n* Age \\> or equal to 18 years, \\\u003C or equal to 70yrs\n* KPS \\> or equal to 80 for Flu\u002FCy\u002FThio\u002FTBI; KPS \\> 60 for Flu\u002FTreo\u002FTBI\n* Patients without a suitable HLA-matched related or unrelated donor\n* Patient with the following CB units:\n\n  * At least two 4-8\u002F8 HLA high resolution matched CB units. Both must have a cell dose of 1.5x107 TNC\u002Fkg each and 1.5x105 CD34+\u002Fkg\n  * A minimum of 1 CB unit as back up.\n* Concurrent Therapy for Extramedullary Leukemia or CNS Lymphoma: Concurrent therapy or prophylaxis for testicular leukemia, CNS leukemia, and CNS lymphoma including standard intrathecal chemotherapy and\u002For radiation therapy will be allowed as clinically indicated. Such treatment may continue until the planned course is completed. Subjects must be in CNS remission at the time of protocol enrollment if there is a history of CNS involvement. Maintenance therapy after transplant is allowed.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for 12 months after the last dose of abatacept.\n* A woman is considered to be of childbearing potential if she is \\\u003C 60 years old, postmenarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus).\n\n  * Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with female partners of reproductive potential, and agreement to refrain from donating sperm, as defined below:\n\n  * With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for 12 months after the last dose of abatacept. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 12 months after the last dose of abatacept.\n  * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n* Patients with inadequate Organ Function as defined by:\n\n  * Creatinine clearance \\\u003C 50ml\u002Fmin\n  * Bilirubin \\> 2X institutional upper limit of normal unless Gilbert syndrome\n  * AST (SGOT) \\> 3X institutional upper limit of normal\n  * ALT (SGPT) \\> 3X institutional upper limit of normal\n  * Pulmonary function: DLCOc \\\u003C 60% normal\n  * Cardiac: left ventricular ejection fraction \\\u003C 50\n* Patients with uncontrolled inter-current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding women are excluded from this study because chemotherapy involved with RIC have the significant potential for teratogenic or abortifacient effects.\n* Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.\n* Presence of donor-specific antibodies against chosen graft source.\n* Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) \\> 5.\n* Prior autologous or allogenic stem cell transplant within the preceding 12 months.","65 Years",{"count":321,"type":21},20,[73],"The goal of this clinical trial is to see if adding abatacept to tacrolimus and MMF prevents or reduces the chances of acute graft versus host disease which is a complication that can occur after transplant in participants with blood cancer. The usual therapy for graft versus host disease prevention after a cord blood transplant includes tacrolimus and MMF. The main question this clinical trial aims to answer is whether or not abatacept will be safe and effective in reducing aGVHD rates in dCBT.\n\nParticipants will:\n\n* Partake in exams, tests, and procedures as part of usual cancer care.\n* Partake in conditioning, which is the treatment that is given before a transplant.\n* Have a cord blood transplant.\n* Partake in radiation following the transplant.",[29,325,31,102,326,327,27,35],"Acute Lymphatic Leukemia","Myelodysplastic Syndrome Other","Chronic Myelomonocytic Leukemia",[329,330,331,332],"Chronic Myelomonocytic Lymphoma","Umbilical Cord Blood Transplant","Double Umbilical Cord Transplant","Cord blood","2025-06-02",{"date":335,"type":51},"2025-06-04",{"date":337,"type":51},"2025-02-25",{"date":339,"type":21},"2028-10-31",{"name":341,"class":58},"Leland Metheny",{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":16,"minAge":350,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":353,"conditions":354,"keywords":355,"overallStatus":260,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":87},"100529603","role-of-bmp-pathway-in-mds-progression-100529603","NCT06175923","Role of BMP Pathway in MDS Progression","Role of the BMP Pathway in Myelodysplastic Syndromes Progression and in the Transition to Acute Myeloid Leukemia","BMP-MDS","Inclusion Criteria:\n\n* Adult patients with myelodysplastic syndrome or suspected myelodysplastic syndrome according to the criteria defined by the World Health Organization Or\n* Adult patient with suspicion of de novo acute myeloid leukemia at initial treatment\n\nExclusion Criteria:\n\n* Frontier MDS\u002Fmyeloproliferative syndromes including chronic myelomonocytic leukemia\n* MDS and AML having already benefited from cytotoxic treatment including hydroxycarbamide, azacytidine, intensive chemotherapy\n* Patients objecting to their inclusion in the study\n* Pregnant or breastfeeding women\n* Patients under legal protection measure","20 Years",{"count":352,"type":21},60,"Myelodysplastic syndromes (MDS) are hematological cancers that can progress to acute myelogenous leukemia (AML). The involvement of the microenvironment in the maintenance, resistance and evolution of MDS is increasingly described.\n\nThe Bone Morphogenetic Protein (BMP) pathway is involved in numerous functions, including self-renewal of the hematopoietic stem cell compartment and the regulation of hematopoiesis, via interaction with bone marrow stromal cells. Investigators have demonstrated its involvement in chronic myeloid leukemia (CML) and AML, in particular via the activation of TWIST1, ΔNp73, NANOG; it is responsible for an increased state of quiescence of certain cancer stem cells and their resistance.\n\nPreliminary results based on the analysis of large databases suggest that the BMP pathway is also altered early in MDS. This study explores the alteration of this pathway in MDS and its involvement in the transformation into AML.\n\nIf appropriate, the BMP pathway could constitute a very promising therapeutic target to combat transformation into AML.",[102,29],[356,357,295,358],"BMP","MSC","microenvironment","2024-01-19",{"date":361,"type":51},"2024-01-23",{"date":363,"type":21},"2024-01-27",{"date":365,"type":21},"2034-01-27",{"name":367,"class":58},"Hospices Civils de Lyon"]