Clinical Trial: Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission

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 Summary:

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.


Sponsor: Eastern Cooperative Oncology Group

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: January 7, 2005
Date Started:
Date Completion:
Last Updated: July 6, 2006
Last Verified: July 2006