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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorNantes University Hospital

About this trial

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

Qualifiers

Age: ≥ 18 and ≤ 70 years old

Patient with hematologic malignancy

Indication for HSC allograft with attenuated conditioning

Pluripotent stem cell (PSC) engraftment

Disqualifiers

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 carcinoma of the skin or a carcinoma in situ of the uterine cole treated and in remission.

Trial design

Treatments tested in this trial

  • Methotrexate
  • Post-Transplant Cyclophosphamide
  • Fludarabine
  • Cycophosphamide
  • Anti-Thymoglobulin
  • total body irradiation
  • hematopoietic stem cells
  • Graft nuclear cells
  • Donor Lymphocytes Injection
  • Clofarabine
  • Thiotepa
  • Busulfan
  • Fludarabine

Treatment groups

82 Participants
are divided into 2 treatment groups

Sponsors and collaborators