A multi-centre phase II trial of GvHD prophylaxis following unrelated donor stem cell transplantation comparing Thymoglobulin vs. Calcineurin inhibitor or Sirolimus-based post-transplant cyclophosphamide.
Availability of suitably matched unrelated donor (9/10 or 10/10)
Fludarabine-Melphalan (Fludarabine 120-180mg/m2 IV; melphalan ≤ 150mg/m2 IV)
BEAM or LEAM (carmustine 300mg/m2 IV or lomustine 200mg/m2 IV with: etoposide 800 mg/m2 IV; cytarabine 1600mg/m2 IV; melphalan 140mg/m2 IV)
Fludarabine-Busulphan (Fludarabine 120-180mg/m2 IV; Busulphan ≤ 8mg/kg PO or 6.4mg/kg IV)
Use of any method of graft manipulation (excluding storage of future DLI)
Use of alemtuzumab or any method of T cell depletion except those that are protocol-defined
Known hypersensitivity to study drugs or history of hypersensitivity to rabbits
Pregnant or lactating women
Parallel
Thymoglobulin
DrugGVHD prophylaxis
Cyclophosphamide
DrugPost transplant cyclophosphamide strategy for GVHD prophylaxis
Cyclosporine
Drugimmunosuppressant
Sirolimus
Drugimmunosuppressant
Mycophenolate Mofetil
Drugimmunosuppressant
GVHD-free, relapse-free survival
GVHD assessment scoring will be performed as per the modified Glucksberg criteria (revised by MAGIC) and the National Institutes of Health (NIH) criteria. GvHD-free, relapse-free survival (GRFS) defined as the time from date of day 0 (defined as the day of stem cell infusion) to the date of first event or death from any cause. An event is defined as GvHD (both acute and chronic), relapse or progression. Patients who are alive and event free at the end of the trial will be censored at their date of last follow-up
Cumulative incidence of acute grade II-IV and III-IV GvHD
GVHD assessment scoring will be performed as per the modified Glucksberg criteria (revised by MAGIC) and the National Institutes of Health (NIH) criteria. GvHD-free
Cumulative incidence of moderate and severe chronic GvHD
GVHD assessment scoring will be performed as per the modified Glucksberg criteria (revised by MAGIC) and the National Institutes of Health (NIH) criteria. GvHD-free
Cumulative incidence of NRM
Non-relapse mortality (NRM) is defined as the time from day 0 to date of non-relapse death. Patients who die post-relapse from any other cause will be considered a competing risk and patients alive at the end of the trial will be censored at their date last seen.
Overall survival
Overall survival (OS) is defined as the time from day 0 to date of death, from any cause. Patients who are alive at the end of the trial will be censored at their date last seen.
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University of Birmingham
Lead sponsor
The Jon Moulton Charity Trust
Collaborator
IMPACT (funded by NHS Blood & Transplant, Anthony Nolan and Leukaemia UK)
Collaborator
