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 (BM12)
Australasian Leukaemia and Lymphoma Group (ALLG)Dataset description
This dataset includes data for BM12 CAST trial participants (73 male, 61 female, ages 21-70) with ALL, AML, MDS , taking part in the Phase III 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. Participants were recruited at sites in Victoria, New South Wales, Queensland, Western Australia, Adelaide, and New Zealand and includes data from 2 years on study, and 3 year period in follow up. The study commenced in 2019 and conducted the last patient last visit in 2024. Dataset includes Timepoints at screening, day +30, +90, +180 and +365 for correlative samples collected which included BMAT to determine remission status including MRD, peripheral blood donor chimerism analysis, measurement of plasma cytokine levels for GVHD biomarkers, peripheral blood MNCs and peripheral blood for molecular MRD assays, the QoL assessments were made at baseline and days +30, +60, +90, +180, +365 and +730 using FACT-BMT, FACT-Fatigue, EORTC QLQ-C30, EQ-5D-5L, and COST-FACIT tools. Cancer Australia demographic data: • Year of birthDate Information
Identifiers
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12618000505202
Funding
Government body, NHMRC
Scientific enquiries
A/Prof David Curtis
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 .... Read more
Key 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).
Key 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
Can healthy volunteers participate?
No
Population
Sample Size 134
Min. age 18 Years
Max. age 70 Years
Sex Both males and females
Condition category Acute Leukaemias , Myelodysplasia
Condition code Blood , Cancer
Intervention
Intervention code Treatment: Drugs
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
Comparison
Control group Active
The GVHD prophylaxis consists of oral cyclosporin starting from day -1 and iv methotrexate 15 mg/m2 day +1 and 10 mg/m2 on days +3, +6 and +11. 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
Outcomes
Outcome: Graft versus host disease and relapse free survival (GRFS) - composite endpoint GVHD-free/relapse-free survival (GRFS) is measured from the date of allogeneic HSCT to the earliest occurrence of any of the following events: grade 3-4 acute GVHD, NIH moderate or severe chronic GVHD, disease relapse or death from any cause.Timepoint: 24 months post transplant