Using post-transplant cyclophosphamide and ATG for blood cancer transplants
Efficacy Evaluation of Post-transplant Cyclophosphamide-based Graft-versus-host Disease Prophylaxis with ATG, Calcineurin Inhibitor-free, for Matched-sibling or Matched-unrelated Transplantation
PHASE1; PHASE2 · Instituto Nacional de Cancer, Brazil · NCT06299462
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Instituto Nacional de Cancer, Brazil (other gov) |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Rio de Janeiro, Rio de Janeiro) |
| Trial ID | NCT06299462 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with hepatic dysfunction or those outside the specified age range may not benefit from this 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 performed: Previous studies have shown success with post-transplant cyclophosphamide in haploidentical transplants, suggesting potential for similar benefits in matched transplants.
Eligibility criteria
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 this trial is running
Rio de Janeiro, Rio de Janeiro
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Hodgkin Lymphoma, Non-hodgkin Lymphoma, posttransplant cyclophosphamide, ATG, calcineurin-free GVHD prophylaxis