A Randomized Pilot Trial to test the feasibility of comparing anti-thymocyte globulin plus post transplant cyclophosphamide with anti-thymocyte globulin alone to prevent chronic graft versus host disease.
Patients with acute leukemia or myelodysplastic syndrome will be randomized to receive, or not receive, post transplant cyclophosphamide in addition to anti-thymocyte globulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
Post Transplant Cyclophosphamide
Anti-Thymocyte Globulin (rabbit, Thymoglobulin)
Kinghorn Cancer Centre, St Vincent's Health Network
Darlinghurst, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Australasian Leukaemia and Lymphoma Group
Melbourne, Victoria, Australia
Registration of 80 patients within twenty four months
Registration will be documented by the Clinical Research Organization (Ozmosis Research Inc.)
Time frame: 24 months
CRFS
Chronic graft versus host disease free- and relapse-free survival (CRFS)
Time frame: 27 months
GRFS
Graft versus host disease-, and relapse-, free survival (GRFS)
Time frame: 27 months
Survival
Survival (dead/alive) at 100 days for each patient
Time frame: 27 months
Complete data collection
The Clinical Research Organization (Ozmosis Research Inc.) will document completeness of data collection
Time frame: 27 months
Cost of study
The sponsor (McMaster University) and the Clinical Research Organization (Ozmosis Research Inc.) will compare actual total trial costs in Canadian dollars at trial completion (at completion of outcomes analysis and report) with expected costs as determined for the trial budget.
Time frame: 27 months
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CancerCare Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada
Saskatchewan Cancer Agency
Saskatoon, Saskatchewan, Canada