Acute Myeloid Leukemia T Cell Depletion to Improve Transplants in Adults With Acute Myeloid Leukemia (BMT CTN 0303)
Leukemia, Myelocytic, Acute
About this trial
This is an interventional treatment trial for Leukemia, Myelocytic, Acute
Eligibility Criteria
Inclusion Criteria: Patients with AML with or without prior history of myelodysplastic syndrome based on the World Health Organization criteria at the following stages: First morphologic complete remission (CR) Second morphologic CR If prior history of central nervous system (CNS) involvement, no evidence of active CNS leukemia during the pre-transplant evaluation (no evidence of leukemic blasts in cerebrospinal fluid) First or second CR was achieved after no more than two cycles of induction (or re-induction for patients in second CR) chemotherapy No more than 6 months elapsed from documentation of CR to transplant for patients in first CR, or 3 months for patients in second CR. A 6/6 HLA antigen (A, B, DRB1)-compatible sibling donor; the match may be determined at serologic level for HLA-A and HLA-B loci; DRB1 must be matched at least at low-resolution using DNA typing techniques; HLA-C will be typed at the serologic level, but not included in the match algorithm Karnofsky performance status greater than 70% Life expectancy greater than 8 weeks Diffusing capacity of the lung for carbon monoxide (DLCO) of at least 40% (corrected for hemoglobin) with no symptomatic pulmonary disease Left ventricular ejection fraction (LVEF) by Multi Gated Acquisition Scan (MUGA) or echocardiogram greater than 40% Serum creatinine greater than 2 mg/dL, bilirubin greater than 2 mg/dL, and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at least 3 times the upper limit of normal at time of enrollment Willingness of both the patient and the donor to participate Exclusion Criteria: M3-AML (acute promyelocytic leukemia) in first CR Acute leukemia following blast transformation of prior chronic myelogenous leukemia (CML) or other myeloproliferative disease M4Eo-AML with inv 16 in first CR AML with t(8;21) in first CR Participation in other clinical trials that involve investigational drugs or devices except with permission from the Medical Monitor Evidence of active Hepatitis B or C infection or evidence of cirrhosis HIV positive Uncontrolled diabetes mellitus If proven or probable invasive fungal infection, infection must be controlled; patients may be on prophylactic anti-fungal agents, but are not permitted to be on anti-fungal agents for therapeutic purposes (i.e., active treatment for disease) Uncontrolled viral or bacterial infection (currently taking medication without clinical improvement) Documented allergy to iron dextran or murine proteins Pregnant or breastfeeding; women of childbearing age must avoid becoming pregnant while in the study Prior autologous or allogeneic hematopoietic stem cell transplantation (HSCT)
Sites / Locations
- City of Hope National Medical Center
- University of California, San Francisco
- Dana Farber Cancer Institute/Brigham & Women's Hospital
- Memorial Sloan-Kettering Cancer Center
- University Hospitals of Cleveland/Case Western
- Ohio State/Arthur G. James Cancer Hospital
- University of Pennsylvania Cancer Center
- Medical College of Wisconsin
Arms of the Study
Arm 1
Experimental
CD34+ selection with CliniMACS device
T cell depletion using Miltenyi device