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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).

CBMTG 1901: List

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.

CBMTG 1901: List
CBMTG 1901: Text
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