Status:
ACTIVE_NOT_RECRUITING
Fludarabine and Total Body Irradiation 800 Centigray (cGy) or 1125 cGy For Allogeneic Stem Cell Transplant Using Graft Versus Host Disease Prophylaxis With Post-Transplant Cyclophosphamide and Tacrolimus, Without Mycophenolate Mofetil
Lead Sponsor:
Ronald Paquette
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a pilot study to evaluate the feasibility, safety and potential benefits of removing one immune suppressive drug called mycophenolate mofetil (MMF) from the standard allogenic stem cell transp...
Eligibility Criteria
Inclusion
- Patient age 18-75 years
- Patient has a related donor who is at least Human Leukocyte Antigen (HLA) haploidentical, or an unrelated donor who is a most a single HLA antigen mismatch.
- Patient signs the Informed Consent Form for the study
- Patient has a hematologic malignancy other than myelofibrosis and meets standard criteria for allogeneic stem cell transplant.
- Patient is deemed suitable to receive Fludarabine and Total Body Irradiation (Flu/TBI) 1125 or Flu/TBI 800 conditioning regimen as standard of care transplant
- Donor is willing to donate peripheral blood stem cells
Exclusion
- Patient has a diagnosis of myelofibrosis
- Patient has high titer antibodies against one or more donor HLA antigens
- Patient has undergone prior autologous or allogeneic stem cell transplant.
- Inability to collect sufficient peripheral blood stem cells from the donor
Key Trial Info
Start Date :
April 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05256537
Start Date
April 26 2022
End Date
March 7 2026
Last Update
December 8 2025
Active Locations (1)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048