Study of using Cyclophosphamide After Sibling-donor allogeneic stem-cell Transplantation (CAST) in patients with acute leukaemia and myelodysplasia
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.
Australasian Leukaemia and Lymphoma Group
134 participants
Apr 4, 2019
Interventional
Conditions
Summary
This study aims to demonstrate a drug called cyclophosphamide is better than the current standard of care at preventing graft versus host disease in patients who have just had a bone marrow transplant. Who is it for? You may be eligible for this study if you are aged 18-70 and have AML or ALL which is in remission, or MDS with <20% myeloblasts; and have a 6/6 matched sibling bone marrow donor. Study details Participants in this study will be randomly assigned (by chance) to one of two treatments. One group will take the study medication cyclophosphamide for 5 days, followed by 90 days of cyclosporin. The other group will take an existing medication regimen of cyclosporine and methotrexate, which is the current standard of care for preventing GVHD. Participants will be followed-up for 2 years post-transplant. The study will look at the number of patients in each treatment arm who develop GVHD, and how each treatment affects the patient quality of life.
Eligibility
Inclusion Criteria4
- -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 Criteria5
- 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
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Interventions
The GVHD prophylaxis consists of post-transplant iv cyclophosphamide 50 mg/kg on Day +3, +4 and oral cyclosporin commencing on Day +5, Cyclosporin lasts 90 days Cyclosporin dosing is as per institution’s standard practice. The protocol recommends maintaining trough cyclosporin level at > 140 µg/l in the absence of toxicity
Locations(10)
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ACTRN12618000505202