Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18 - 70
Clinical summary
Summary
Patients enrolled in this trial will be randomly assigned to one of two treatment options. In group one, patients will receive the trial drug, Cyclophosphamide, for 5 days, followed by 90 days of cyclosporin. Patients in the other group will receive an existing medication regimen of cyclosporine and methotrexate, which is the current standard of care for Graft versus Host disease (GVHD) prevention.
Conditions
This trial is treating people with Graft versus Host disease
Eligibility
Inclusion
• 18-70 years of age
• Adult patients with AML/ALL in remission or MDS with <20% myeloblasts
• Availability of 6/6-matched sibling donor
• Adequate cardiac (LVEF greater than or equal to 40%), pulmonary (DLCO/VA >50%) and renal function (Creatinine Clearance greater than or equal to 60 ml/min).
Exclusion
• Donor other than a sibling
• Graft source other than G-CSF mobilised PBSC
• Use of in-vitro or in-vivo T-cell depletion
• Life expectancy from co-morbid medical conditioning less than 12 months
• Uncontrolled infection
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
National Health & Medical Research Council (NHMRC)
Scientific Title
Study of using Cyclophosphamide After Sibling-donor allogeneic stem-cell Transplantation (CAST) in patients with acute leukaemia and myelodysplasia: a randomised study comparing cyclosporin and methotrexate to cyclosporin and post-transplantation cyclophosphamide for graft-versus-host disease prophylaxis
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