A randomized pilot trial comparing anti-thymocyte globulin with anti-thymocyte globulin plus post transplant cyclophosphamide for prophylaxis against acute and chronic graft versus host disease in matched donor hematopoietic cell transplants - a study from the Cell Therapy Transplant Canada/ Australasian Leukemia Lymphoma Group Consortium.
Bone marrow transplant patients given either of two different immunosuppressive regimens both achieved excellent survival, establishing safety for larger trials.
This randomized pilot trial compared ATG alone versus ATG plus PTCy for GVHD prophylaxis in 79 AML/MDS patients undergoing matched-donor HCT, finding non-inferior 100-day survival (95%) in both arms. The results establish the safety profile needed to design a larger randomized trial comparing these GVHD prophylaxis strategies.
What the study was
- Study design
- Randomized pilot trial
- Population
- AML (n=55) and MDS (n=24) patients undergoing matched-donor HCT, Canada/Australia
- Sample size
- 79
- Category
- Treatment Innovation
- Maturity
- Exploratory
- Journal
- Bone marrow transplantation
Why it surfaced
Randomized design in AML/MDS transplant setting; addresses critical GVHD prophylaxis question with clear future trial implications.
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