Reduced Intensity Conditioning Versus Myeloablative Conditioning for Acute Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)

Status: Recruiting
Phase:
Diagnosis: Leukemia/MDS
NCT ID: NCT01339910 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-039

 

The study is designed as a Phase III, multicenter trial comparing outcomes after allogeneic hematopoietic stem cell transplantation (HCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) between patients receiving myeloablative conditioning (MAC) versus reduced intensity conditioning (RIC) regimens.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Dana Farber Cancer Institute at South Shore Hospital

Overall PI:
Edwin Alyea, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

Inclusion Criteria: - Age equal or less than 65 years old and equal to or greater than 18 years old. - Patients with the diagnosis of MDS or AML with fewer than 5% myeloblasts in the bone marrow and no leukemic myeloblasts in the peripheral blood on morphologic analysis performed within 30 days of start of the conditioning regimen enrollment. - For patients receiving treatment of their MDS or AML prior to transplantation: a)Interval between the start of the most recent cycle of conventional cytotoxic chemotherapy and enrollment must be at least 30 days; b)Interval between completing treatment with a hypomethylating agent or other non-cytotoxic chemotherapy and enrollment must be at least 10 days. - Patients must have a related or unrelated bone marrow or peripheral blood donor who is HLA-matched at 7 or 8 of 8 HLA-A, -B, -C and -DRB1 at high resolution using DNA-based typing. - HCT-Specific Comorbidity Index Score (HCT-CI) less than or equal to 4. - Organ function: a) Cardiac function: Ejection fraction greater than or equal to 40%; b) Hepatic function: total bilirubin less than or equal to 2 times the upper limit of normal and ALT and AST less than or equal to 3 times the upper limit of normal.; c)Pulmonary function: DLCO greater than or equal to 40% and FEV1 greater than or equal to 50% (corrected for hemoglobin. - Creatinine clearance greater than or equal to 50mL/min based on the Cockcroft-Gault formula. - Signed informed consent. Exclusion Criteria: - Prior allograft or prior autograft. - Symptomatic coronary artery disease. - Leukemia involvement in the CNS within 4 weeks of enrollment for patients with a history of prior CNS leukemia involvement (i.e., leukemic blasts previously detected in the cerebral spinal fluid). - Karnofsky Performance Score less than 70. - Patients receiving supplemental oxygen. - Planned use of DLI therapy. - Patients with uncontrolled bacterial, viral or fungal infections (undergoing appropriate treatment and with progression of clinical symptoms). - Patients seropositive for the human immunodeficiency virus (HIV). - Patients with prior malignancies, except resected basal cell carcinoma or treated cervical carcinoma in situ. Cancer treated with curative intent greater than 5 years previously. Cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Protocol Officer or one of the Protocol Chairs. - Females who are pregnant or breastfeeding. - Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment.
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