CBMTG 2501
A Pragmatic Randomized Trial comparing Antithymocyte Globulin (ATG) or Post Transplant Cyclophosphamide (PTCy) with ATG plus PTCy Prophylaxis against Acute and Chronic Graft Versus Host Disease (aGVHD, cGVHD) in Matched Donor Hematopoietic Stem Cell Transplants (HSCT).
TRIAL SUMMARY
HYPOTHESIS
The combination of ATG and PTCy will result in superior CGRFS compared to current standard of care (ATG or PTCy alone)
DESIGN
Multicenter, Non-Blinded, Randomized Pragmatic Trial
PRIMARY ENDPOINT
The primary endpoint is chronic graft versus host disease, relapse free survival (CGRFS)
INCLUSION CRITERIA
Ages 16-70, transplant being performed for a malignant disease, 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.
EXCLUSION CRITERIA
Poor condition (centre determined), active infection, HIV infection, T-cell antibody prophylaxis (anti-CD52), use of cord blood grafts or T-cell depleted grafts
PREPARATIVE REGIMENS
Myeloablative or Reduced Intensity protocol (to be declared at outset)
SUPPORTIVE MEASURES
Institutional practices. Quantitative EBV testing is strongly recommended.
ANTI-THYMOCYTE GLOBULIN
Thymoglobulin® 2 mg/kg to 4.5 mg/kg total dose, centre to determine prior to randomization
CYCLOPHOSPHAMIDE PTCY
Cyclophosphamide 50 mg/kg IV on days +3 and +4 - for those randomized.