Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 60

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.

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Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment50 (estimated)
SponsorInstituto Nacional de Cancer, Brazil
Government
Drugs / interventionscyclophosphamide
Locations1 site (Rio de Janeiro, Rio de Janeiro)
StatusRecruiting
StartedJune 14, 2024
Main results expectedJune 1, 2031
Study endsJune 1, 2031
Registry record updatedFebruary 25, 2025
Trial IDNCT06299462 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.