PTCy and ATG for MSD and MUD Transplants

Sponsor
Instituto Nacional de Cancer, Brazil
Study ID
NCT06299462
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • ATG 5.0 — DRUG
    ATG 2.5 mg/kg on days -3 and -2
  • Cyclophosphamide injection — DRUG
    Cyclophosphamide 50 mg/kg on days +3 and +4
  • ATG 4.0 — DRUG
    ATG 2.5 mg/kg on day -2 + 1.5 mg/kg on day -3

Study Details

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.

Key Dates

First listed
Mar 7, 2024
Start date
Jun 14, 2024
Status verified
Mar 2024
Primary completion
Jun 1, 2031
Completion
Jun 1, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Matched-sibling donor transplants
    Matched sibling transplants will receive PTCy + ATG4.0
  • Experimental: Matched unrelated donor transplants
    Unrelated transplants will receive PTCy + ATG5.0

Primary Outcome Measure

Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria [ Time Frame: 6 months ]

Central Contacts

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