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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Instituto Nacional de Cancer
Rio de Janeiro, Rio de Janeiro, Brazil
RECRUITINGCumulative incidence of grades III-IV acute GVHD by the MAGIC criteria
Cumulative incidence of acute graft-versus-host disease, grades III-IV by the MAGIC criteria
Time frame: 6 months
Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria
Cumulative incidence of acute graft-versus-host disease, grades II-IV by the MAGIC criteria
Time frame: 6 months
Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949
Cumulative incidence of steroid-refractory graft-versus-host disease
Time frame: 6 months
Cumulative incidence of chronic GVHD as defined by the NIH criteria
Cumulative incidence of chronic graft-versus-host disease
Time frame: 3 years
Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria
Cumulative incidence of steroid-requiring chronic graft versus host disease
Time frame: 3 years
Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse
Cumulative incidence of death not caused by primary malignant disease or following 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)
Cumulative incidence of relapse of primary malignant disease
Time frame: 3 years
Rate of overall survival
Death by any cause
Time frame: 3 years
Rate of disease-free survival (death or relapse)
Composite outcome of death or primary disease relapse
Time frame: 3 years
Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment)
Incidence of cytomegalovirus reactivation
Time frame: 3 year
Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms)
Incidence of posttransplant lymphoproliferative disorder
Time frame: 3 years
Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL)
Cumulative incidence of cytomegalovirus disease
Time frame: 3 years
Measuremnt of quality of life using the FACT-BMT scale
Measurement quality of life
Time frame: 2 years
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