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.
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;
None
Parallel
ATG 5.0
DrugATG 2.5 mg/kg on days -3 and -2
Cyclophosphamide injection
DrugCyclophosphamide 50 mg/kg on days +3 and +4
ATG 4.0
DrugATG 2.5 mg/kg on day -2 + 1.5 mg/kg on day -3
Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria
Cumulative incidence of acute graft-versus-host disease, grades III-IV by the MAGIC criteria
Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria
Cumulative incidence of acute graft-versus-host disease, grades II-IV by the MAGIC criteria
Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949
Cumulative incidence of steroid-refractory graft-versus-host disease
Cumulative incidence of chronic GVHD as defined by the NIH criteria
Cumulative incidence of chronic graft-versus-host disease
Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria
Cumulative incidence of steroid-requiring chronic graft versus host disease
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