Идёт набор NCT06299462

PTCy and ATG for MSD and MUD Transplants

Фаза I / Фаза II С лечением Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndromes Hodgkin Lymphoma

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: ATG 5.0, Cyclophosphamide injection, ATG 4.0.
Кому может быть актуально: Состояния в реестре: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Hodgkin Lymphoma. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy Evaluation of Post-transplant Cyclophosphamide-based Graft-versus-host Disease Prophylaxis with ATG, Calcineurin Inhibitor-free, for Matched-sibling or Matched-unrelated Transplantation

Обзор

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.

Вмешательства

Препарат ATG 5.0
ATG 2.5 mg/kg on days -3 and -2
Препарат Cyclophosphamide injection
Cyclophosphamide 50 mg/kg on days +3 and +4
Препарат ATG 4.0
ATG 2.5 mg/kg on day -2 + 1.5 mg/kg on day -3

Первичные конечные точки

Cumulative incidence of grades III-IV acute GVHD by the MAGIC criteria [Срок оценки: 6 months]

Вторичные конечные точки (12)

Cumulative incidence of grades II-IV acute GVHD by the MAGIC criteria [Срок оценки: 6 months]
Cumulative incidence of steroid-refractory acute GVHD as defined by Mohty et al PMID 32756949 [Срок оценки: 6 months]
Cumulative incidence of chronic GVHD as defined by the NIH criteria [Срок оценки: 3 years]
Cumulative incidence of steroid-requiring chronic GVHD as defined by the NIH criteria [Срок оценки: 3 years]
Cumulative incidence of non-relapse mortality, i.e., death not following disease relapse [Срок оценки: 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) [Срок оценки: 3 years]
Rate of overall survival [Срок оценки: 3 years]
Rate of disease-free survival (death or relapse) [Срок оценки: 3 years]
Cumulative incidence of clinically significant CMV reactivation (which led to antiviral treatment) [Срок оценки: 3 year]
Cumulative incidence of posttransplant lymphoproliferative disorder (biopsy-proven or positive EBV PCR combined with clinical symptoms) [Срок оценки: 3 years]
Cumulative incidence CMV disease (biopsy-proven CMV disease OR suggestive CMV+ BAL) [Срок оценки: 3 years]
Measuremnt of quality of life using the FACT-BMT scale [Срок оценки: 2 years]

Критерии участия

Критерии включения

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.