Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
- Conditions
- Adult Acute Erythroid LeukemiaAdult Acute Monoblastic and Acute Monocytic LeukemiaAdult Acute Myeloid Leukemia
- Registration Number
- NCT00101140
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method