At a glance
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A Phase II Study to Assess Immunosuppression With Sirolimus Combined With Cyclosporine (CSP) and Mycophenolate Mofetil (MMF) for Prevention of Acute GVHD After Non-Myeloablative HLA Class I or II Mismatched Donor Hematopoietic Cell Transplantation- A Multi-Center Trial
In Brief
A Phase 2 clinical trial evaluating Allogeneic Hematopoietic Stem Cell Transplantation, Cyclosporine, and 6 other interventions for Adult Acute Lymphoblastic Leukemia and 23 related conditions. Completed, enrolled 77 participants across 5 sites in 2 countries.
Detailed Summary
This phase II trial studies how well sirolimus, cyclosporine and mycophenolate mofetil works in preventing graft-vs-host disease (GVHD) in patients with blood cancer undergoing donor peripheral blood stem cell (PBSC) transplant. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with sirolimus, cyclosporine, and mycophenolate mofetil before and after transplant may stop this from happening.
Study Details
Timeline
Interventions
Undergo allogeneic peripheral blood stem cell transplant
Given PO or IV
Given IV
Correlative studies
Given PO
Undergo allogeneic peripheral blood stem cell transplant
Given PO
Undergo total-body irradiation