[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myelogenous-leukemia-aml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myelogenous-leukemia-aml":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100558216","phase-1-a-phase-1b2a-trial-of-nadunolimab-in-combination-with-azacitidine-withwithout-venetoclax-in-patients-with-myelodysplastic-syndrome-mds-and-acute-myelogenous-leukemia-aml-100558216",false,"NCT06548230","A Phase 1B\u002F2A Trial of NADUNOLIMAB in Combination With Azacitidine (With\u002FWithout Venetoclax) in Patients With Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)","Inclusion Criteria:\n\n1. Diagnosis\n\n   * Arm 1: Diagnosis of MDS intermediate\u002Fhigh\u002Fvery high risk by Revised International Prognostic Scoring System (IPSS-R), Untreated or up to 2 prior treatments.\n   * Arm 2: Diagnosis of relapsed\u002Frefractory AML (per European Leukemia Network 2022) \\[26\\] receiving treatment as salvage 1-2. MDS or CMML treated with hypomethylating agent (HMA) therapies who progress to AML and have no available better therapies or are not candidates for available therapies, will be eligible at the time of progression to AML.\n2. Patients aged ≥18 years\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2\n4. Temporary prior measures such as apheresis, limited dose cytarabine or use of hydrea while eligibility work-up is being performed are allowed and not counted as a prior salvage\n5. In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks or at least 5 half-lives (whichever is shorter). The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document.\n6. The toxicity from prior therapy should have resolved to Grade ≤1, however alopecia and sensory neuropathy Grade ≤2 not constituting a safety risk based on investigators judgement is acceptable.\n7. The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled CNS leukemia at the discretion of the PI. (2) Use of 1-2 doses of cytarabine (up to 1.5 g\u002Fm2 each dose) for patients with rapidly proliferative disease is allowed up to 7 days before the start of study therapy (7 days washout). Use of hydroxyurea for patients with rapidly proliferative disease is allowed on study and before the start of study therapy and will not require a washout. These medications will be recorded in the case-report form.\n8. Concurrent therapy for CNS prophylaxis or continuation of therapy for controlled CNS disease is permitted. Patients with a known history of CNS disease must have been treated with CNS directed therapy, have at least 2 consecutive LPs with no evidence of CNS leukemia, and must be clinically stable for at least 4 weeks prior to enrollment and have no ongoing neurological symptoms that in the opinion of the treating physician are related to the CNS disease\n9. Serum biochemical values with the following limits:\n\n   1. Patients must have adequate renal function as demonstrated by a creatinine clearance (CrCl) ≥ 40 mL\u002Fmin calculated by either the Cockcroft-Gault formula, Modification of Diet in Renal Disease (MDRD) eGFR or measured by 24 hours' urine collection. For patients with BMI \\>23, Adjusted body weight and not Ideal Body Weight is the recommended parameter.\n   2. Direct bilirubin \\\u003C1.5 x ULN unless considered due to Gilbert's syndrome\n   3. Aspartate aminotransferase or alanine aminotransferase ≤2.0 x ULN (aspartate aminotransferase or alanine aminotransferase ≤3.0 x ULN if deemed related to leukemia by the treating physician)\n10. White blood cell count \\\u003C10 x 109\u002FL. Hydroxyurea may be used to reduce the WBC count to \\\u003C 10x109\u002FL.\n11. Ability to understand and provide signed informed consent.\n12. Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative serum or urine pregnancy test within 72 hours before the start of the treatment\n13. Women of childbearing potential must agree to use an adequate method of contraception during the study and until 4 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment.\n\nExclusion Criteria:\n\n1. Patients with any other known concurrent severe and\u002For uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study.\n2. Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed.\n3. Prior organ transplantation including allogenic stem-cell transplantation within 3 months prior to planned enrollment, active graft versus host disease (GVHD) \\>Grade 1 or requiring transplant-related immunosuppression with the exception of low dose cyclosporine and tacrolimus.\n4. Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia.\n5. Patients with a known HIV infection that is not well controlled (i.e. any detectable circulating viral load) at the time of enrollment.\n6. Patients with known positive hepatitis B or C infection by serology, with the exception of those with an undetectable viral load within 3 months (Hepatitis B or C testing is not required prior to study entry). Subjects with serologic evidence of prior vaccination to HBV \\[i.e., HBs Ag-, and anti-HBs+\\] may participate.\n7. Patients who have had any major surgical procedure within 14 days of Day 1.\n8. Other severe acute or chronic medical conditions that is active and not well controlled including colitis, inflammatory bowel disease, or psychiatric conditions including active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.\n9. Active and uncontrolled disease (active infection requiring systemic therapy or fever likely secondary to infection within prior 48 hours): prophylactic antibiotics or prolonged course of IV antibiotics for controlled infection are allowed, uncontrolled hypertension despite adequate medical therapy, active and uncontrolled congestive heart failure NYHA class III\u002FIV, clinically significant and uncontrolled arrhythmia, as judged by the treating physician.\n10. Requirement to use anti-TNF drugs (infliximab, etanercept, adalimumab, certolizumab, golimumab).\n11. Patients unwilling or unable to comply with the protocol.\n12. Live vaccination within 28 days from start of therapy","ALL","18 Years",{"count":18,"type":19},40,"ESTIMATED","INTERVENTIONAL",[22,23],"PHASE1","PHASE2","To evaluate safety and determine the recommended Phase II dose (RP2D). We hypothesize that targeting leukemia stem\u002Fprogenitor cells (LSCs) with nadunolimab (IL1RAP antibody) alone or in combination with current therapies of azacitidine (HMA) and venetoclax (Bcl-2 inhibitor), is an effective treatment strategy for high-risk MDS and AML, and with a clinical trial we will establish the safety and the early efficacy of this approach.",[26,27],"Myelodysplastic Syndrome(MDS)","Acute Myelogenous Leukemia (AML)","RECRUITING","2026-03-05",{"date":31,"type":32},"2026-03-09","ACTUAL",{"date":34,"type":32},"2025-03-05",{"date":36,"type":19},"2029-12-01",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":15,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100220190","phase-2-hsct-for-patients-with-fanconi-anemia-using-risk-adjusted-chemotherapy-100220190","NCT02143830","HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy","A Phase II Trial of HSCT for the Treatment of Patients With Fanconi Anemia Lacking a Genotypically Identical Donor, Using a Risk-Adjusted Chemotherapy Only Cytoreduction With Busulfan, Cyclophosphamide and Fludarabine","RAFA","Inclusion Criteria:\n\n* Patients must have a diagnosis of Fanconi anemia\n* Patients must have one of the following hematologic diagnoses:\n\n  1. Severe Aplastic Anemia (SAA), with bone marrow cellularity of \\\u003C25% OR Severe Isolated Single Lineage Cytopenia and at least one of the following features:\n\n     1. Platelet count \\\u003C20 x 109\u002FL or platelet transfusion dependence\\*\n     2. ANC \\\u003C1000 x 109\u002FL\n     3. Hgb \\\u003C8 gm\u002Fdl or red cell transfusion dependence\\*\n  2. Myelodysplastic Syndrome (MDS) (based on WHO or IPSS Classification\n  3. Acute Myelogenous Leukemia (untreated, in remission or with refractory or relapsed disease)\n* Donors will be either human leukocyte antigen (HLA) compatible unrelated or HLA-genotypically matched related donors (no fully matched sibling donor).\n* Patients and donors may be of either gender or any ethnic background.\n* Patients must have a Karnofsky adult, or Lansky pediatric performance scale status \\> 70%.\n* Patients must have adequate physical function measured by:\n\n  1. Cardiac: asymptomatic or if symptomatic then 1) left ventricular ejection fraction (LVEF) at rest must be \\> 50% and must improve with exercise or 2) Shortening Fraction \\> 29%\n  2. Hepatic: \\\u003C 5 x upper limit of normal (ULN) alanine transaminase (ALT) and \\\u003C 2.0 mg\u002Fdl total serum bilirubin.\n  3. Renal: serum creatinine \\\u003C1.5 mg\u002Fdl or if serum creatinine is outside the normal range, then CrCl \\> 50 ml\u002Fmin\u002F1.73 m2\n  4. Pulmonary: asymptomatic or if symptomatic, DLCO \\> 50% of predicted\n* Each patient must be willing to participate as a research subject and must sign an informed consent form.\n* Female patients and donors must not be pregnant or breastfeeding at the time of signing consent. Women must be willing to undergo a pregnancy test prior to transplant and avoid becoming pregnant while on study.\n\nExclusion Criteria:\n\n* Active CNS leukemia\n* Female patients who are pregnant (positive serum or urine HCG) or breast-feeding.\n* Active uncontrolled viral, bacterial or fungal infection\n* Patient seropositive for HIV-I\u002FII; HTLV -I\u002FII","3 Months",{"count":51,"type":19},70,[23],"The purpose of this study is to determine whether the use of lower doses of busulfan and the elimination of cyclosporine will further reduce transplant-related side effects for patients with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or matched unrelated donors following a preparative regimen of busulfan, fludarabine, anti-thymocyte globulin and cyclophosphamide.",[55,56,57,27],"Fanconi Anemia","Severe Marrow Failure","Myelodysplastic Syndrome (MDS)",[59,60,61,62,63,64,65],"marrow aplasia","cytopenia","myelodysplasia","AML","bone marrow transplant","cytoreductive regimen","T-cell reduction","2025-11-10",{"date":68,"type":32},"2025-11-12",{"date":70,"type":4},"2014-04",{"date":72,"type":19},"2028-12",{"name":74,"class":39},"Children's Hospital Medical Center, Cincinnati",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":15,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":20,"phases":86,"briefSummary":87,"conditions":88,"keywords":94,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":40},"100507203","phase-2-cord-blood-transplant-in-adults-with-blood-cancers-100507203","NCT05884333","Cord Blood Transplant in Adults With Blood Cancers","Optimized Cord Blood Transplantation for the Treatment of High-Risk Hematologic Malignancies in Adults","Inclusion Criteria:\n\n* I. Acute myelogenous leukemia (AML):\n* Complete first remission (CR1) at high risk for relapse such as any of the following:\n\n  * Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPD).\n  * Therapy-related AML.\n  * Presence of extramedullary leukemia at diagnosis.\n  * Requirement for 2 or more inductions to achieve CR1.\n  * Intermediate or high ELN2017 genetic risk AML.\n  * Any patient unable to tolerate consolidation chemotherapy as would have been deemed appropriate by the treating physician.\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or greater (CR2+).\n* Patients in morphologic remission with persistent cytogenetic, flow cytometric, or molecular aberrations are eligible\n\nII. Acute lymphoblastic leukemia (ALL):\n\n* Complete first remission (CR1) 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 MLL rearrangements (11q23) or other high-risk molecular abnormality.\n  * Failure to achieve MRD- complete remission after induction therapy.\n  * Persistence or recurrence of minimal residual disease on therapy.\n  * Any patient unable to tolerate consolidation and\u002For maintenance chemotherapy as would have been deemed appropriate by the treating physician.\n  * Other high-risk features not defined above.\n* Complete second remission (CR2) or greater (CR2+). Note: ALL with less than 5% blasts at time of transplant but persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n\nIII. Other acute leukemias: Acute leukemias of ambiguous lineage or mixed phenotype with less than 5% blasts. Leukemias in morphologic remission with persistent cytogenetic, flow cytometric or molecular aberrations are eligible.\n\nIV. Myelodysplastic Syndromes (MDS) and Myeloproliferative Disorders (MPD) other than myelofibrosis:\n\n* International prognostic scoring system (IPSS) risk score of INT-2 or high risk at the time of diagnosis.\n* Any IPSS risk category if life-threatening cytopenia(s) exists.\n* Any IPSS risk category with karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia.\n* MDS\u002FMPD overlap syndromes without myelofibrosis.\n* MDS\u002F MPD patients must have less than 10% bone marrow myeloblasts and ANC \\> 0.2 (growth factor supported if necessary) at transplant work-up.\n\nV. Non-Hodgkin lymphoma (NHL) at high-risk of relapse or progression if not in remission:\n\nEligible patients with aggressive histologies (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell histologies) in CR by PET\u002FCT imaging.\n\no Eligible patients with indolent B-cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2 nd or subsequent progression with PR or CR by PET\u002FCT imaging.\n\nVI. Blastic plasmacytoid dendritic cell neoplasm (BPDCN) in morphologic remission.\n\nOrgan Function and Performance Status Criteria:\n\n* Karnofsky score equal or greater than 80% (See Appendix B; inpatient Leukemia service transfers without discharge are acceptable provided patient has equivalent KPS as if were outpatient).\n* Calculated creatinine clearance \\> 70 ml\u002Fmin.\n* Bilirubin \\\u003C 1.5 mg\u002FdL (unless benign congenital hyperbilirubinemia or hemolysis).\n* ALT \\\u003C 3 x upper limit of normal (ULN).\n* Pulmonary function: Spirometry (FVC and FEV1) and corrected DLCO) \\> 60% predicted.\n* Left ventricular ejection fraction (MOD-bp)\\> 50%.\n* Albumin \\> 3.0.\n* Hematopoietic Cell Transplantation Comorbidity index (HCT-CI) ≤5.\n\nGraft criteria:\n\nTwo CB units will be selected according to current MSKCC CB unit selection algorithm. High resolution 8-allele HLA typing and recipient HLA antibody profile will be performed. Unit selection will occur based on HLA-match, total nucleated cell (TNC) and CD34+ cell dose adjusted per patient body weight. The bank of origin will also be considered. Donor specific HLA antibodies, if present, will also be taken into consideration and may influence the selection of the graft.\n\n* Each CB unit must be at least 3\u002F8 HLA-matched to the patient considering high-resolution 8-allele HLA typing. \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to have a cryopreserved TNC dose of at least 1.5 x 10\\^7 TNC\u002F recipient body weight (TNC\u002F kg). \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to have a cryopreserved CD34+ cell dose of at least 1.5 x 10\\^5 CD34+ cells\u002F recipient body weight (CD34+ cells\u002Fkg). \\[Taken from the Cord Blood Summary\\]\n* A minimum of one unit will be reserved as a backup graft. \\[Taken from the Cord Blood Summary\\]\n* Each CB unit will be required to be cryopreserved in standard cryovolume (24-27 ml\u002Fs per unit or per bag if unit in two bags) and be red blood cell depleted. \\[Taken from the Cord Blood Summary\\]\n\nExclusion Criteria:\n\n* Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.\n* Patients with persistent with CNS involvement in CSF or CNS disease at time of screening\n* Prior checkpoint inhibitors\u002F blockade in the last 12 months.\n* Two prior stem cell transplants of any kind.\n* One prior autologous stem cell transplant within the preceding 12 months.\n* Prior allogeneic transplantation.\n* Prior involved field radiation therapy that would preclude safe delivery of 400cGy TBI in the opinion of Radiation Oncology.\n* Active and uncontrolled infection at time of transplantation.\n* HIV infection.\n* Seropositivity for HTLV-1.\n* Inadequate performance status\u002F organ function.\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.","21 Years","65 Years",{"count":85,"type":19},54,[23],"Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard (\"optimized\") practice for cord blood transplant (CBT). This optimized practice includes how patients are evaluated for transplant, the conditioning treatment (standard chemotherapy and total body irradiation therapy) given to prepare the body for transplant, the amount of stem cells transplanted, and how patients are followed during and after transplant.The purpose of this study is to collect information about participant outcomes after CBT following MSK's optimized practice. The researchers will look at outcomes of the CBT treatment such as side effects, disease relapse, GVHD, and immune system recovery after CBT treatment.",[27,89,90,91,92,93],"Acute Lymphoblastic Leukemia (ALL)","Chronic Myelogenous Leukemia (CML)","Myelodysplastic Syndromes (MDS)","Myeloproliferative Disorder","Non-Hodgkin's Lymphoma",[95,96,97,98,99,100,101],"Cord Blood Transplant","CYCLOPHOSPHAMIDE (CYTOXAN)","CYCLOSPORINE A","FLUDARABINE","MYCOPHENOLATE MOFETIL (MMF)","THIOTEPA","23-143","2025-09-05",{"date":104,"type":32},"2025-09-08",{"date":106,"type":32},"2023-05-22",{"date":108,"type":19},"2028-05-22",{"name":110,"class":39},"Memorial Sloan Kettering Cancer Center"]