BMT-06: Study of Intensity Modulated Total Marrow Irradiation (IM-TMI)
BMT-06: Phase II Study of Intensity Modulated Total Marrow Irradiation (IM-TMI) in Addition to Fludarabine/Cyclophosphamide and Post-Transplant Cyclophosphamide Conditioning for Partially HLA Mismatched Allogeneic Transplantation in Patients With Acute Leukemia and Myelodysplastic Syndrome (MDS)
About This Trial
This study is being done to see if the addition of a targeted form of radiation to standard conditioning regimen will increase the amount of cancer cells that are killed off in the bone marrow and reduce the chances that your disease may return. This description is called Intensity Modulated Total Marrow Irradiation (IM-TMI).
Who May Be Eligible (Plain English)
Original Eligibility Criteria
View original clinical language
Treatments Being Tested
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2
Conditioning regimen with half-matched (haploidentical) stem cell transplant
All patients will receive the following standard conditioning regimen: Fludarabine 30 mg/m2 IVPB daily from Day -6 (6 days before stem cell infusion) through Day -2
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Total body irradiation 2Gy on Day -1.
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Stem cell infusion on Day 0.
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Mesna 14.5 mg/kg IV starting 30 minutes prior to cyclophosphamide on Days -6 and -5 and continuing for at least 12 hours after end of cyclophosphamide
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Cyclophosphamide 50 mg/kg IV on Days 3 and 4 after transplant at a dose of 50mg/kg per day
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Mesna 10 mg/kg IV every 4 hours for 10 doses starting 1 hour prior to cyclophosphamide on Days 3 and 4
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Tacrolimus 0.03 mg/kg IBW Q24H starting on Day 5
Conditioning regimen with half-matched (haploidentical) stem cell transplant
Mycophenolate mofetil (MMF) 15 mg/kg PO TID (maximum daily dose of 3g/day) starting on Day 5