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RecruitingLast updated: 26 February 2024

CAST: This phase III trial is trying to determine whether a chemotherapy drug (Cyclophosphamide) is better than the current standard of care at preventing graft versus host disease in patients that have recently received a bone marrow transplantStudy 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

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 patients with Graft versus Host disease

Cancer

Blood Cancers Haematological

Age

People18 - 70

Phase

III

Trial Acronym

CAST

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Trial Identifiers

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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

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.
Message

Clinical trials have complex eligibility criteria.

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