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Trial Title: PTCy and ATG for MSD and MUD Transplants

NCT ID: NCT06299462

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

Conditions: Official terms:
Lymphoma
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Cyclophosphamide

Conditions: Keywords:
posttransplant cyclophosphamide
ATG
calcineurin-free GVHD prophylaxis
graft-versus-host disease

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Intervention model description: 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

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ATG 5.0
Description: ATG 2.5 mg/kg on days -2 and -1
Arm group label: Matched unrelated donor transplants

Intervention type: Drug
Intervention name: Cyclophosphamide injection
Description: Cyclophosphamide 50 mg/kg on days +3 and +4
Arm group label: Matched unrelated donor transplants
Arm group label: Matched-sibling donor transplants

Intervention type: Drug
Intervention name: ATG 2.5±1.5
Description: ATG 2.5 mg/kg on day -1 ± 1.5 mg/kg on day -2
Arm group label: Matched-sibling donor transplants

Summary: 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.

Criteria for eligibility:
Criteria:
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: - Renal dysfunction (Cr > 1.5 mg/dL) - Hepatic dysfunction (transaminases x2 the normal value)

Gender: All

Minimum age: 18 Years

Maximum age: 60 Years

Healthy volunteers: No

Locations:

Facility:
Name: Instituto Nacional de Cancer

Address:
City: Rio de Janeiro
Zip: 20230-130
Country: Brazil

Status: Recruiting

Contact:
Last name: Leonardo J Arcuri, MD

Phone: +55(21)3207-1304
Email: leonardojavier@gmail.com

Contact backup:
Last name: Simone Lermontov

Phone: +55(21)3207-1261
Email: simonelermontov@globo.com

Start date: June 20, 2024

Completion date: June 1, 2031

Lead sponsor:
Agency: Instituto Nacional de Cancer, Brazil
Agency class: Other

Source: Instituto Nacional de Cancer, Brazil

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06299462

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