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.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618000505202

Acronym

CAST

Enrollment

134

Registered

2018-04-06

Start date

2019-04-04

Completion date

2024-01-30

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

• 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 criteria

• 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

Outcome results