NCT06252870 Study Testing Two Conditioning Regimen With a Single Prophylaxis of GVHD by Cyclophosphamide and Methotrexate Post-transplant in Patients Eligible for Matched-donor Allograft Transplantation
| NCT ID | NCT06252870 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nantes University Hospital |
| Condition | Graft Versus Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2027-10-18 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
Graft-versus-host disease (GVHD) is a major complication of allogeneic hematopoietic stem cell transplantation (allo-CSH). Recently, in the context of semi-identical (=haploidentical) HLA donors, but also of compatible HLA donors, the use of cyclophosphamide (CY) administered in high doses at early post-transplant (PT) (=PTCY) (Days +3 and +4 or +5) has shown excellent control of acute and chronic GVH, even enabling the discontinuation of other immunosuppressive drugs administered after allo-CSH (ciclosporin, mycophenolate mofetyl (MMF) or Cellcept). This step has already been taken in the context of allo-CSH with myeloablative conditioning (MAC), which is a minoritary conditioning in adults. However, in the context of allo-CSH with reduced-intensity conditioning (RIC), which predominates in adults, this strategy seems insufficient to prevent the risk of GVHD. The idea of reducing the use of immunosuppressants in the context of RIC/HLA-compatible transplants seems, however, still relevant, in order to reduce their adverse effects, improve patients' quality of life and enhance the reconstitution of the post-transplant immune system.
Eligibility Criteria
Inclusion Criteria: * Age: ≥ 18 and ≤ 70 years old * Patient with hematologic malignancy * Indication for HSC allograft with attenuated conditioning * Pluripotent stem cell (PSC) engraftment * Availability of a 10/10 familial or non-familial HLA compatible donor * Consent to the protocol * ECOG \<=2 * Woman of childbearing age with negative pregnancy test and on highly effective contraception during treatment and for a period of 12 months after stopping MTX and CY * Man of childbearing age with highly effective contraception during treatment and for a period of 6 months after stopping MTX and CY and a period of 12 months after stopping MTX and CY if TBF conditioning regimen arm * Negative Hepatitis B, C, HIV serologies * Social security affiliation Exclusion Criteria: * History of allograft * Patient eligible for myeloablative conditioning (MAC) * Bone marrow transplant * Other progressive cancerous disease, or antecedent of cancer in the last five years, with the exception of a carcin