Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission
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|ClinicalTrials.gov Identifier: NCT00101140|
Recruitment Status : Withdrawn
First Posted : January 10, 2005
Last Update Posted : October 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|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|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Official Title:||Phase II Study of Haploidentical Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With High-Risk Acute Myeloid Leukemia in First Remission|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00101140
|Study Chair:||Mark R. Litzow, MD||Mayo Clinic|
|OverallOfficial:||Jacob M. Rowe, MD||Rambam Health Care Campus|