A Randomized Pilot Trial comparing Anti-Thymocyte Globulin (ATG) with ATG plus Post Transplant Cyclophosphamide (PTCy) for Prophylaxis against Acute and Chronic Graft Versus Host Disease (GVHD) in Matched Donor Hematopoietic Cell Transplants (HCT).
The combination of ATG and PTCy will be safe, and a subsequent Phase III trial comparing the addition of PTCy to ATG will be feasible.
Multicenter, Non-Blinded, Randomized Controlled Pilot Trial
The primary endpoint is feasibility, a compound endpoint requiring recruitment of 80 patients within 18 months, within budget, and without excessive toxicity, post-transplant lymphoproliferative disorder, graft versus host disease or mortality, in the experimental arm compared with the standard arm.
Ages 16-70, either acute myeloblastic leukemia or myelodysplastic syndrome, blood progenitor cell grafts from MHC matched (8/8) family or unrelated donors (8/8 or 7/8), and either myeloablative or reduced intensity conditioning.
Poor condition (centre determined), acute leukemia in relapse, myelodysplastic syndrome with >10% marrow blasts, second transplants, active infection, HIV infection, T-cell antibody prophylaxis (anti-CD52), use of cord blood grafts or T-cell depleted grafts
Myeloablative or Reduced Intensity protocol (to be declared at outset)
Institutional practices. Quantitative EBV testing is strongly recommended.
Thymoglobulin® 4.5 mg/kg total dose (schedule: 0.5 mg/kg day -2; 2.0 mg/kg days -1 and +1) – all participants.
Cyclophosphamide 50 mg/kg IV on days +3 and +4 - for those randomized.