PTCy and ATG for MSD and MUD Transplants
- Conditions
- Acute Myeloid LeukemiaAcute Lymphoblastic LeukemiaMyelodysplastic SyndromesHodgkin LymphomaNon-hodgkin Lymphoma
- Interventions
- Registration Number
- NCT06299462
- Lead Sponsor
- Instituto Nacional de Cancer, Brazil
- Brief 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-3 and D-2 for matched-sibling or unrelated donors transplants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- Hepatic dysfunction (transaminases x2 the normal value)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matched-sibling donor transplants Cyclophosphamide injection Matched sibling transplants will receive PTCy + ATG4.0 Matched-sibling donor transplants ATG 4.0 Matched sibling transplants will receive PTCy + ATG4.0 Matched unrelated donor transplants ATG 5.0 Unrelated transplants will receive PTCy + ATG5.0 Matched unrelated donor transplants Cyclophosphamide injection Unrelated transplants will receive PTCy + ATG5.0
- Primary Outcome Measures
Name Time Method Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria 6 months Cumulative incidence of acute graft-versus-host disease, grades III-IV by the MAGIC criteria
- Secondary Outcome Measures
Name Time Method Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria 6 months Cumulative incidence of acute graft-versus-host disease, grades II-IV by the MAGIC criteria
Cumulative incidence of chronic GVHD as defined by the NIH criteria 3 years Cumulative incidence of chronic graft-versus-host disease
Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria 3 years Cumulative incidence of steroid-requiring chronic graft versus host disease
Rate of overall survival 3 years Death by any cause
Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949 6 months Cumulative incidence of steroid-refractory graft-versus-host disease
Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse 3 years Cumulative incidence of death not caused by primary malignant disease or following relapse
Cumulative incidence of relapse, defined as > 5% blasts in bone marrow or 1% blasts in peripheral blood (acute leukemias/myelodysplasia) or biopsy proven relapse or positve PET-CT (lymphoma) 3 years Cumulative incidence of relapse of primary malignant disease
Rate of disease-free survival (death or relapse) 3 years Composite outcome of death or primary disease relapse
Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment) 3 year Incidence of cytomegalovirus reactivation
Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms) 3 years Incidence of posttransplant lymphoproliferative disorder
Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL) 3 years Cumulative incidence of cytomegalovirus disease
Measuremnt of quality of life using the FACT-BMT scale 2 years Measurement quality of life
Trial Locations
- Locations (1)
Instituto Nacional de Cancer
🇧🇷Rio de Janeiro, Brazil