At a glance
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A Randomized Phase II Study of Treosulfan, Fludarabine and Low-Dose TBI as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML)
In Brief
A Phase 2 clinical trial evaluating Allogeneic Bone Marrow Transplantation, Fludarabine Phosphate, and 4 other interventions for Acute Myeloid Leukemia in Remission and 5 related conditions. Targeting 102 participants across 1 site.
Detailed Summary
This randomized phase II trial studies how well treosulfan and fludarabine phosphate, with or without total body irradiation before donor stem cell transplant works in treating patients with myelodysplastic syndrome or acute myeloid leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor 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. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and mycophenolate mofetil after the transplant may stop this from happening.
Study Details
Timeline
Interventions
Undergo allogeneic bone marrow transplant
Intravenously administered Fludarabine Phosphate
Undergo allogeneic PBSC transplant
Undergo TBI
Intravenously administered Treosulfan
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