Trials / Withdrawn
WithdrawnNCT00101140
Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 18 Years – 59 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Adult Acute Erythroid Leukemia
- Adult Acute Monoblastic and Acute Monocytic Leukemia
- Adult Acute Myeloid Leukemia
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- First posted
- 2005-01-10
- Last updated
- 2017-10-19
Source: ClinicalTrials.gov record NCT00101140. Inclusion in this directory is not an endorsement.