Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission.
|Adult Acute Erythroid Leukemia Adult Acute Monoblastic and Acute Monocytic Leukemia Adult Acute Myeloid Leukemia||Drug: anti-thymocyte globulin Drug: fludarabine phosphate Drug: thiotepa Procedure: biological therapy Procedure: bone marrow ablation with stem cell support Procedure: chemotherapy Procedure: non-specific immune-modulator therapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission|
- Determine the safety and antileukemia activity of haploidentical allogeneic peripheral blood stem cell transplantation in patients with high-risk acute myeloid leukemia in first remission.
- Determine the early treatment-related mortality (before day 100) of patients treated with this regimen.
- Determine the incidence of acute graft-versus-host disease in patients treated with this regimen.
- Determine the incidence of graft failure in patients treated with this regimen.
- Correlate a mismatch in the expression of the natural killer cell inhibitory receptors CD158a and CD158b with engraftment and disease recurrence in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive a preparative regimen comprising total-body irradiation twice on day –8; fludarabine IV over 30 minutes on days –7 to –3; thiotepa IV over 2 hours twice on day –7; and antithymocyte globulin IV over 4-6 hours on days –5 to –2. Patients undergo haploidentical allogeneic peripheral blood stem cell transplantation on day 0.
Patients are followed at day 100, at least monthly for 2 years, and then periodically for 3 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study within 2.2 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00101140
|Study Chair:||Mark R. Litzow, MD||Mayo Clinic|
|OverallOfficial:||Jacob M. Rowe, MD||Rambam Health Care Campus|