NCT06299462 PTCy and ATG for MSD and MUD Transplants
| NCT ID | NCT06299462 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Instituto Nacional de Cancer, Brazil |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-06-14 |
| Primary Completion | 2031-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2024-06-14 with a primary completion date of 2031-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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). 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.
Eligibility 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)
Contact & Investigator
Leonardo J Arcuri, MD, PhD
PRINCIPAL INVESTIGATOR
Instituto Nacional de Cancer
Frequently Asked Questions
Who can join the NCT06299462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06299462 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06299462 currently recruiting?
Yes, NCT06299462 is actively recruiting participants. Contact the research team at leonardojavier@gmail.com for enrollment information.
Where is the NCT06299462 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil.
Who is sponsoring the NCT06299462 clinical trial?
NCT06299462 is sponsored by Instituto Nacional de Cancer, Brazil. The principal investigator is Leonardo J Arcuri, MD, PhD at Instituto Nacional de Cancer. The trial plans to enroll 50 participants.
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