Spots Global Cancer Trial Database for Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial