Treosulfan and Fludarabine Phosphate With or Without Total Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01894477

Treosulfan and Fludarabine Phosphate With or Without Total Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

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.

Status: 
Recruiting
Study Date: 
Fri, 11/01/2013 to Thu, 11/01/2018
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Associated Drug(s): 
Intervention: 
Procedure: Allogeneic Bone Marrow Transplantation Undergo allogeneic bone marrow transplant Other Names: Allo BMT Allogeneic BMT Drug: Fludarabine Phosphate Given IV Other Names: 2-F-ara-AMP 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)- Beneflur Fludara Oforta SH T 586 Other: Laboratory Biomarker Analysis Correlative studies Procedure: Peripheral Blood Stem Cell Transplantation Undergo allogeneic PBSC transplant Other Names: PBPC transplantation Peripheral Blood Progenitor Cell Transplantation Peripheral Stem Cell Support Peripheral Stem Cell Transplantation Radiation: Total-Body Irradiation Undergo TBI Other Names: TOTAL BODY IRRADIATION Whole-Body Irradiation Drug: Treosulfan Given IV Other Names: 1,2,3, 4-Butanetetrol, 1,4-dimethanesulfonate, [R-(R*,S*)]- Dihydroxybusulfan Ovastat Treosulphan Tresulfon