CBMTG 1901

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).

 

TRIAL SUMMARY

HYPOTHESIS

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.

DESIGN

Multicenter, Non-Blinded, Randomized Controlled Pilot Trial

PRIMARY ENDPOINT

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.

INCLUSION CRITERIA

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.

EXCLUSION CRITERIA

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

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® 4.5 mg/kg total dose (schedule: 0.5 mg/kg day -2; 2.0 mg/kg days -1 and +1) – all participants.

CYCLOPHOSPHAMIDE PTCY

Cyclophosphamide 50 mg/kg IV on days +3 and +4 - for those randomized.