RecruitingPhase 1Phase 2NCT06299462

PTCy and ATG for MSD and MUD 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


Sponsor

Instituto Nacional de Cancer, Brazil

Enrollment

50 participants

Start Date

Jun 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two immune-suppressing drugs — post-transplant cyclophosphamide (PTCy) and anti-thymocyte globulin (ATG) — to prevent graft-versus-host disease (where donor immune cells attack the recipient's body) after a bone marrow transplant. **You may be eligible if...** - You are 18–60 years old - You have acute leukemia in first or second remission, myelodysplastic syndrome with fewer than 20% blasts, or Hodgkin's or non-Hodgkin's lymphoma with a partial response after salvage treatment - You are receiving a compatible stem cell transplant from a related or unrelated donor using peripheral blood - You are medically suitable for the transplant conditioning regimens used in the study **You may NOT be eligible if...** - Your liver function is significantly impaired (liver enzymes more than double the normal range) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGATG 5.0

ATG 2.5 mg/kg on days -3 and -2

DRUGCyclophosphamide injection

Cyclophosphamide 50 mg/kg on days +3 and +4

DRUGATG 4.0

ATG 2.5 mg/kg on day -2 + 1.5 mg/kg on day -3


Locations(1)

Instituto Nacional de Cancer

Rio de Janeiro, Rio de Janeiro, Brazil

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NCT06299462


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