At a glance
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A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Busulfan, and 7 other interventions for Adult Acute Lymphoblastic Leukemia in Remission and 46 related conditions. Completed, enrolled 40 participants across 1 site.
Detailed Summary
This phase II trial studies how well reduced intensity donor stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
Study Details
Timeline
Interventions
Given IV
Given IV
2 Gy administered as part of the conditioning regimen
Undergo DLI
Given IV
Given IV or PO
Given IV
Undergo CD34+ allogeneic PBSCT
Undergo CD34+ allogeneic PBSCT