[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-relapsed-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-relapsed-adult":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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},"100366362","phase-2-clag-go-for-patients-with-persistent-relapsed-or-refractory-aml-100366362",false,"NCT04050280","CLAG-GO for Patients With Persistent, Relapsed or Refractory AML","A Phase II Study of Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor With Fractionated Gemtuzumab Ozogamicin (CLAG-GO) for the Treatment of Patients With Persistent, Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Adult patients age 18 years or older, with a pathologically confirmed diagnosis of AML \\[excluding acute promyelocytic leukemia (APL)\\] according to WHO criteria. AML may be de novo, or following a prior hematologic disease and\u002For therapy-related.\n2. Patients must have relapsed after or be refractory to at least one course of an intensive chemotherapy regimen, for example anthracycline\u002Fcytarabine (\"7+3\" or daunorubicin and cytarabine liposome). Patients with residual disease on day 13-22 of initial induction chemotherapy are eligible, provided the bone marrow cellularity is ≥ 30% AND bone marrow blasts are ≥ 20%. Hypomethylating agents such as azacitidine or decitabine are allowed as a prior therapy, but are not considered an intensive chemotherapy regimen.\n3. Eastern Cooperative Oncology Group performance status of 0-2.\n4. Any systemic chemotherapy and any radiotherapy must be completed at least 7 days prior to initiation of protocol therapy, with the exception of hydroxyurea or 6-mercaptopurine for cytoreduction.\n5. At least 20% expression of CD33 as determined by flow cytometry or immunohistochemical staining.\n6. Adequate renal function, defined as a serum creatinine less than 1.8 mg\u002FdL.\n7. Adequate hepatic function, defined as a direct bilirubin less than 2 times the institutional upper limit of normal (ULN) and AST, ALT and Alkaline Phosphatase less than 3 times the ULN.\n8. Patients who relapse after allogeneic hematopoietic stem cell transplantation are eligible, provided they are at least 60 days from stem cell infusion, do not have \\> grade 1 graft versus host disease, and have been off all immunosuppressive therapy for at least 2 weeks.\n9. Female patients of childbearing potential must have a negative pregnancy test and agree to use an adequate method of contraception as defined by the protocol. This must persist through the treatment period until at least 6 months after the last dose of chemotherapy or GO.\n10. Male subjects who are able to father children and are having intercourse with females of childbearing potential must also agree to an acceptable method of contraception through the treatment period until at least 3 months after the last dose of chemotherapy or GO, and must refrain from sperm donation during this period.\n11. Ability to give written informed consent.\n\nExclusion Criteria:\n\n1. Patients with acute promyelocytic leukemia (FAB-M3) or chronic myelogenous leukemia in blast phase.\n2. Isolated myeloid sarcoma. Patients must have marrow involvement with AML to enter the study.\n3. Patients with known active AML involvement of the central nervous system.\n4. Prior treatment with gemtuzumab ozogamicin or cladribine for AML. Prior treatment with cytarabine is permitted.\n5. As patients will be receiving G-CSF prior to chemotherapy, patients presenting with symptomatic leukostasis (as judged by the investigator) are excluded. Hydroxyurea, 6-mercaptopurine and\u002For leukapheresis for blast count control (see inclusion criterion #4) for patients with asymptomatic hyperleukocytosis is permitted before starting treatment, but must be stopped for at least 24 hours prior to starting protocol treatment.\n6. Active uncontrolled infection. Patients on prophylactic antibacterial, antifungal, and\u002For antiviral agents and patients whose infections are controlled with these agents are eligible.\n7. Known active hepatitis B or C or other known active hepatic disorder.\n8. Any history of veno-occlusive disease (VOD)\u002Fsinusoidal obstruction syndrome (SOS).\n9. Active concurrent malignancy, unless disease-free for at least 3 years. Subjects with treated non-melanoma skin cancer, in situ carcinoma or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed. Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been treated surgically or with definitive radiotherapy.\n10. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that per investigator's judgment would limit compliance with study requirements.","ALL","18 Years",{"count":19,"type":20},39,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study involves evaluating a combination of chemotherapy drugs known as \"CLAG-GO\" \\[cladribine, cytarabine, granulocyte-colony stimulating factor (G-CSF) and gemtuzumab ozogamicin (GO)\\] in the treatment of acute myeloid leukemia (AML) that has not responded well to standard therapy or has returned after an initial remission (relapsed). The trial will be conducted at the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC). Potential participants will go through a screening period to see if they are eligible to join the study. If eligible, participants will be hospitalized for 4-5 weeks to receive study treatment with CLAG-GO, called induction chemotherapy. If tests show that the cancer is in remission after induction chemotherapy, participants may undergo further chemotherapy (known as consolidation) or may proceed with bone marrow\u002Fstem cell transplantation. Patients who receive consolidation chemotherapy and remain in remission may have up to 8 cycles of outpatient maintenance therapy. A cycle lasts about 28 days. All participants will be monitored carefully for both side effects and to see if the study treatment is working. Lab tests and exams will be conducted throughout the entire study. In addition, special studies will be done at various time points to try to understand better how the drugs work and which patients are likely to respond best.",[26,27,28],"Acute Myeloid Leukemia, Adult","Acute Myeloid Leukemia Recurrent","Acute Myeloid Leukemia, Relapsed, Adult","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2019-11-01",{"date":37,"type":20},"2028-02",{"name":39,"class":40},"University of Maryland, Baltimore","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100577747","phase-2-intensity-modulated-total-marrow-irradiation-in-fully-human-leukocyte-antigen-hla-matched-and-partially-hla-mismatched-allogeneic-transplantation-patients-with-high-risk-acute-myeloid-leukemia-aml-chronic-myeloid-leukemia-cml-and-myelodysplastic-syndrome-mds-100577747","NCT06802315","Intensity Modulated Total Marrow Irradiation in Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk Acute Myeloid Leukemia (AML), Chronic Myeloid Leukemia (CML), and Myelodysplastic Syndrome (MDS)","A Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Myeloablative Fludarabine\u002FBusulfan and Post-Transplant Cyclophosphamide (PTCY) for Fully Human Leukocyte Antigen (HLA)-Matched and Partially-HLA Mismatched Allogeneic Transplantation Patients With High-Risk AML, CML, and MDS","BMT-13","Inclusion Criteria:\n\n* 1\\. Age 18-65 years.\n* 2\\. Patients with CML, AML, or MDS who meet one of the following criteria: 2a. Relapsed or refractory AML (including AML in CR2) 2b. Poor-risk AML in first remission, with remission defined as \\\u003C5% bone marrow blasts morphologically:\n* AML arising from MDS, a myeloproliferative disorder, or secondary AML\n* Poor risk molecular features according to Leukemia Net including ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and\u002For ZRSR2\n* Poor-risk cytogenetics: Monosomal karyotype, complex karyotype (\\> 3 abnormalities), inv (3), t(3;3), t(6;9), MLL rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7. 2c. Primary refractory disease 2d. MDS with at least one of the following poor-risk features:\n* Poor-risk cytogenetics including 3q abnormalities, 7\u002F7q minus or complex cytogenetics (\\>3 abnormalities).\n* Current or previous INT-2 or high IPSS score.\n* Treatment-related MDS.\n* MDS diagnosed before the age of 21 years.\n* Progression on or lack of response to standard DNA-methyltransferase inhibitor therapy.\n* Life-threatening cytopenias, including those requiring regular PRBC or platelet transfusions. 2e. CML with a history of accelerated or blast phase.\n\nExclusion Criteria:\n\n* 1\\. Presence of significant co-morbidity as shown by:\n* 1a. Left ventricular ejection fraction \\\u003C 50%\n* 2b. Creatinine clearance \\\u003C30ml\u002Fmin.\n* 3c. Bilirubin \\> 2.0 mg\u002FdL (unless due to Gilbert's syndrome or hemolysis), and ALT and AST \\> 5 x ULN.\n* 4d. FEV1 and FVC \\\u003C 50% of predicted or DLCO \\\u003C50% of predicted once corrected for anemia.\n* 5e. Karnofsky score \\\u003C70\n* 6f. Active viral hepatitis or HIV infection.\n* 7g. Cirrhosis.\n* 2\\. Pregnancy or breast feeding\n* 3\\. Patients unable to sign informed consent.\n* 4\\. Patients previously received radiation to \\>20% of bone marrow-containing areas.","65 Years",{"count":52,"type":20},38,[23],"The study is a Phase II clinical trial. Patients will receive intensity-modulated total marrow irradiation (TMI) at a dose of 9 Gray (Gy) with standard myeloablative fludarabine intravenous (IV) and targeted busulfan (FluBu4) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (GVHD) prophylaxis will include Cyclophosphamide on Day +3 and +4, tacrolimus, and mycophenolate mofetil.",[28,56,57,58],"Acute Myeloid Leukemia Refractory","Chronic Myeloid Leukemia - Accelerated Phase","Myelodysplastic Syndromes",[60,61,62],"Total Marrow Irradiation","Stem Cell Transplant","Allogenic Transplant","2026-06-23",{"date":65,"type":33},"2026-06-26",{"date":67,"type":33},"2025-02-04",{"date":69,"type":20},"2032-03",{"name":71,"class":40},"University of Illinois at Chicago"]