PTCy and ATG for MSD and MUD Transplants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ATG 5.0, Cyclophosphamide injection, ATG 4.0.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Hodgkin Lymphoma. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy Evaluation of Post-transplant Cyclophosphamide-based Graft-versus-host Disease Prophylaxis with ATG, Calcineurin Inhibitor-free, for Matched-sibling or Matched-unrelated Transplantation
Overview
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.
Interventions
- Drug ATG 5.0
ATG 2.5 mg/kg on days -3 and -2 - Drug Cyclophosphamide injection
Cyclophosphamide 50 mg/kg on days +3 and +4 - Drug ATG 4.0
ATG 2.5 mg/kg on day -2 + 1.5 mg/kg on day -3
Primary outcome measures
- Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria [Time frame: 6 months]
Secondary outcome measures (12)
- Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria [Time frame: 6 months]
- Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949 [Time frame: 6 months]
- Cumulative incidence of chronic GVHD as defined by the NIH criteria [Time frame: 3 years]
- Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria [Time frame: 3 years]
- Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse [Time frame: 3 years]
- 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) [Time frame: 3 years]
- Rate of overall survival [Time frame: 3 years]
- Rate of disease-free survival (death or relapse) [Time frame: 3 years]
- Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment) [Time frame: 3 year]
- Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms) [Time frame: 3 years]
- Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL) [Time frame: 3 years]
- Measuremnt of quality of life using the FACT-BMT scale [Time frame: 2 years]
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
\- Hepatic dysfunction (transaminases x2 the normal value)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Brazil · 1 center
- Instituto Nacional de Cancer — Rio de Janeiro
Identifiers
NCT: NCT06299462 · PTCy-ATG-001