Using post-transplant cyclophosphamide and ATG for blood cancer transplants
Official title: Efficacy Evaluation of Post-transplant Cyclophosphamide-based Graft-versus-host Disease Prophylaxis with ATG, Calcineurin Inhibitor-free, for Matched-sibling or Matched-unrelated Transplantation
Run by Instituto Nacional de Cancer, Brazil · NCT06299462 · Data updated 2026-11-12
This study is testing whether using post-transplant cyclophosphamide and ATG can help prevent graft-versus-host disease in patients with blood cancers who are getting stem cell transplants.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Instituto Nacional de Cancer, Brazil Government |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Status | Recruiting |
| Started | June 14, 2024 |
| Main results expected | June 1, 2031 |
| Study ends | June 1, 2031 |
| Registry record updated | February 25, 2025 |
| Trial ID | NCT06299462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 60 with specific types of blood cancers in remission who are eligible for HLA-compatible stem cell transplants.
✕Probably not a fit
Patients with hepatic dysfunction or those outside the specified age range may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the use of post-transplant cyclophosphamide and anti-thymocyte globulin (ATG) as a prophylactic treatment to prevent graft-versus-host disease (GVHD) in patients undergoing hematopoietic stem cell transplantation. The study focuses on patients with acute leukemia, myelodysplastic syndromes, and lymphomas who are receiving related or unrelated HLA-compatible transplants. It aims to evaluate the effectiveness of this approach compared to traditional calcineurin inhibitors, which have a poorer toxicity profile. The trial is designed as a prospective, two-arm, non-randomized study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of graft-versus-host disease in transplant patients, improving their overall outcomes.
How similar studies have gone: Previous studies have shown success with post-transplant cyclophosphamide in haploidentical transplants, suggesting potential for similar benefits in matched transplants.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with (1) acute leukemia in first or second remission; (2) myelodysplasia with less than 20% blasts; (3) Hodgkin's or non-Hodgkin's lymphoma, in partial remission after salvage therapy * Who will receive a related or unrelated, HLA-compatible transplant; * Who is a transplant candidate with FluMel, FluTBI, CyTBI, BuCy or BuFlu conditioning; * Peripheral blood source; * Age between 18 and 60 years. Exclusion Criteria: \- Hepatic dysfunction (transaminases x2 the normal value)
Where it's running
-
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil Recruiting
Study contacts
- Principal investigator: Leonardo J Arcuri, MD, PhD — Instituto Nacional de Cancer
- Study coordinator: Leonardo J Arcuri, MD, PhD
- Email: leonardojavier@gmail.com
- Phone: +5521981334715
Similar studies
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Vitamin A and D supplementation for patients undergoing allogeneic hematopoietic transplantation
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.