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A Randomized, Multi-Center, Phase III Study of Allogeneic Stem Cell Transplantation Comparing Regimen Intensity in Patients with Myelodysplastic Syndrome or Acute Myeloid Leukemia
|Bone Marrow Transplant (BMT)
|Leukemia, Acute Myeloid (AML)
|Myelodysplastic Syndrome (MDS)
- The primary objective of the randomized trial is to compare 18-month overall survival (OS) rates between the two groups. The hypothesis to be tested is that reducing the intensity of the conditioning regimen will decrease treatment related mortality without increasing relapse so that overall survival will be improved.
- Secondary objectives include comparisons of disease free survival rates after transplantation, rates of transplant-related mortality, incidence of relapse, hematologic recovery, kinetics of donor cell engraftment, incidence of graft failure, incidence and severity of acute and chronic graft versus host disease (GVHD), quality of life, rates of infectious complications, rates of ≥ grade 3 toxicities according to the CTCAE criteria, immune reconstitution and quality of life.
- Age ≤ 65 years and ≥ 18 years.
- 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 enrollment.
- For patients receiving treatment of their MDS or AML prior to transplantation: Interval between the start of the most recent cycle of conventional cytotoxic chemotherapy and enrollment must be at least 30 days. 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. Related donor must be a 7/8 or 8/8 match at HLA-A, -B, -C (serologic typing or higher resolution) and -DRBI (at high resolution using DNA-based typing). Unrelated donor must be a 7/8 or 8/8 match at HLA-A, -B, -C, and -DRBI at high resolution using DNA-based typing.
- HCT Specific Comorbidity Index Score (HCT CI) ≤ 4 (Appendix G)
- Organ function:
- Cardiac function: Ejection fraction ≥ 40 percent
- Hepatic function: total bilirubin ≤ 2x the upper limit of normal and ALT and AST ≤ 3x the upper limit of normal
- Pulmonary function: DLCO ≥ 40 percent and FEV1 ≥ 50 percent (corrected for hemoglobin)
- Estimated Creatinine clearance ≥ 50 mL/min/based on the Cockcroft-Gault formula.
- Signed informed consent.
- 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., leukemia blasts previously detected in the cerebral spinal fluid).
- Karnofsky Performance Score < 70 (Appendix F).
- 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 > 5 years previously will be allowed. Cancer treated with curative intent < 5 yeras 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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