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)
University of Illinois at Chicago
Summary
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).
Description
This is a single arm phase II clinical trial. The usual conditioning regimen for haploidentical transplant is the use of chemotherapy (fludarabine/cyclophosphamide) before the transplant and further chemotherapy with cyclophosphamide after the transplant. In addition, a small dose of radiation is also given. Patients will receive a standard conditioning regimen with fludarabine, cyclophosphamide and total body irradiation (Flu/Cy/TBI) prior to haploidentical hematopoietic stem cell transplant (HSCT). Graft-versus-host disease prophylaxis will include cyclophosphamide 50 mg/kg on Day +3 and 4…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient age 18-75 years 2. Related donor who is, at minimum, Human Leukocyte Antigen (HLA) haploidentical or mismatched unrelated donor. * Haploidentical: The donor and recipient must be identical in at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. A minimum match of 4/8 if using HLA-A,-B,-DRB1,-Cw, or 5/10 if using HLA-A,-B,-Cw ,-DRB1, and -DQB1, will be considered evidence that the donor and recipient share one HLA haplotype. * Unrelated donors: unrelated donors who are mismatched in one or more of the fol…
Interventions
- RadiationConditioning regimen with half-matched (haploidentical) stem cell transplant
Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2
- DrugConditioning 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
- DrugConditioning regimen with half-matched (haploidentical) stem cell transplant
Cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5
- DeviceConditioning regimen with half-matched (haploidentical) stem cell transplant
Total body irradiation 2Gy on Day -1.
- OtherConditioning regimen with half-matched (haploidentical) stem cell transplant
Stem cell infusion on Day 0.
Location
- University of Illinois Cancer CenterChicago, Illinois