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Matched sibling transplants will receive PTCy + ATG2.5 ± ATG1.5

Unrelated transplants will receive PTCy + ATG5.0

ATG 5.0

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

Cyclophosphamide injection

ATG 2.5 mg/kg on day -1 ± 1.5 mg/kg on day -2

ATG 2.5±1.5

Leonardo J Arcuri, MD, PhD

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-1 or on D-2 and D-1, depending on ATG de-escalation, for matched-sibling transplants, according to prespecified criteria based on the 3+3 approach; and on D+3 and D+4 with cyclophosphamide and with ATG on D-2 and D-1, for unrelated donors.

Patients with a matched sibling donor will be assigned to the PTCy+ATG2.5±1.5 arm, while patients with an matched unrelated donor will be assigned to the PTCy+ATG5.0 arm

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

Upon finalization of the study, data will be shared on reasonable requests.

Cumulative incidence of acute graft-versus-host disease, grades III-IV by the MAGIC criteria

Cumulative incidence of acute graft-versus-host disease, grades II-IV by the MAGIC criteria

Cumulative incidence of steroid-refractory graft-versus-host disease

Cumulative incidence of chronic graft-versus-host disease

Cumulative incidence of steroid-requiring chronic graft versus host disease

Cumulative incidence of death not caused by primary malignant disease or following relapse

Cumulative incidence of relapse of primary malignant disease

Composite outcome of death or primary disease relapse

Incidence of cytomegalovirus reactivation

Incidence of posttransplant lymphoproliferative disorder

Cumulative incidence of cytomegalovirus disease

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PTCy and ATG for MSD and MUD Transplants	NCT06299462	Acute Myeloid L... Acute Lymphobla... Myelodysplastic... Hodgkin Lymphom... Non-hodgkin Lym...	ATG 5.0 Cyclophosphamid... ATG 2.5±1.5	18 Years - 60 Years	Instituto Nacional de Cancer, Brazil
PTCy and ATG for MSD and MUD Transplants	NCT06299462	Acute Myeloid L... Acute Lymphobla... Myelodysplastic... Hodgkin Lymphom... Non-hodgkin Lym...	ATG 5.0 Cyclophosphamid... ATG 2.5±1.5	18 Years - 60 Years	Instituto Nacional de Cancer, Brazil

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