PTCy and ATG for MSD and MUD Transplants

Instituto Nacional de Cancer, Brazil

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Hodgkin Lymphoma; Non-hodgkin Lymphoma; Acute Lymphoblastic Leukemia; Myelodysplastic Syndromes; Acute Myeloid Leukemia

Treatments: Drug: ATG 4.0; Drug: ATG 5.0; Drug: Cyclophosphamide injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06299462

PTCy-ATG-001

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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;
• Age between 18 and 60 years.

Exclusion criteria

• Hepatic dysfunction (transaminases x2 the normal value)

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Matched-sibling donor transplants

Experimental group

Description:

Matched sibling transplants will receive PTCy + ATG4.0

Treatment:

Drug: Cyclophosphamide injection

Drug: ATG 4.0

Matched unrelated donor transplants

Experimental group

Description:

Unrelated transplants will receive PTCy + ATG5.0

Treatment:

Drug: Cyclophosphamide injection

Drug: ATG 5.0