Tests a new graft-versus-host prevention plan in blood stem cell transplants
Tests a transplant drug plan in adults with leukemia, lymphoma or myelodysplastic syndromes.
Key facts
- Who runs it
- Instituto Nacional de Cancer, Brazil
- Where
- Rio de Janeiro, BrazilSee the site
- Trial code
- Registry title
- PTCy and ATG for MSD and MUD Transplants
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 50 people, planned
- Started
- 14 Jun 2024
- Expected to end
- 1 Jun 2031
- Type of study
- Interventional, 2 groups
- Treatments tested
- ATG 5.0
- Cyclophosphamide injection
- ATG 4.0
- Record updated
- 25 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 60 with certain blood cancers who will have a stem cell transplant from a related or unrelated donor with a compatible tissue type.
- Age
- 18 to 60 years
- Sex
- All sexes can join.
- Disease stage
- Acute leukemia in first or second remission; myelodysplasia with less than 20% blasts; Hodgkin or non-Hodgkin lymphoma in partial remission after salvage therapy.
- Earlier treatment
- People must be ready for a transplant with a related or unrelated donor with a compatible tissue type (HLA-compatible), using stem cells from peripheral blood. The conditioning before the transplant must be FluMel, FluTBI, CyTBI, BuCy or BuFlu.
Main reasons for not taking part
- Liver problems (transaminases 2 times the normal value)
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Hepatic dysfunction (transaminases x2 the normal value)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Where in Brazil
- Instituto Nacional de CâncerRio de Janeiro, BrazilContact: Leonardo J Arcuri, MDTaking people
About the trial
What the trial wants to find out
Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched).
Read full original descriptionShow less
Since then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch.
This is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant).
Patients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.
The stem cell collection target will be 5E6 CD34/kg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.
Graft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-3 and D-2 for matched-sibling or unrelated donors transplants.
The 2 groups in the trial
- Matched-sibling donor transplantsTreatment being tested
Matched sibling transplants will receive PTCy + ATG4.0
Treatment: Cyclophosphamide injection and ATG 4.0
- Matched unrelated donor transplantsTreatment being tested
Unrelated transplants will receive PTCy + ATG5.0
Treatment: ATG 5.0 and Cyclophosphamide injection
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests a new graft-versus-host prevention plan in blood stem cell transplantsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06299462, who can take part
- Record updated
- 25 February 2025