Study Comparing Reduced Versus Standard Dose Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin as Graft Versus Host Disease Prophylaxis in Alternative Donor Peripheral Stem Cell Transplantation

Официальное название

A Multi-center Randomized Clinical Study Comparing Reduced-dose (35mg/kg) Versus Standard Dose (50mg/kg) Post-transplantation Cyclophosphamide in Combination With Post-engraftment Anti-thymoglobin (ATG) and Tacrolimus and Post-engraftment Anti-thymoglobin as Graft Versus Host Disease (GVHD) Prophylaxis in Patients Undergo Alternative Donor Peripheral Hematopoietic Stem Cell Transplantation

Обзор

This is a multi-center randomized study to compare the reduced-dose of post-transplantation cyclophosphamide (PTCY) at 35mg.kg to standard dose at 50mg/kg combined with tacrolimus and post-engraftment low dose anti-thymoglobin (ATG) as graft versus host disease (GVHD) prophylaxis in patients undergoing allogeneic stem cell transplantation from alternative donor.

Подробное описание

This is a multi-center randomized study in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) from alternative donors (9-10/10 matched unrelated donor or haplo-identical donors). The aim is to evaluate to the efficacy and feasibly of reduced-dose of PTCY at 35mg/kg as GVHD prophylaxis. Patients will be assigned to study group receiving PTCy at 35mg/kg on day +3 and +4 together with tacrolimus starting from day +5 and single dose anti-thymoglobin at 2.5mg/kg as GVHD prophylaxis or to the control group with standard dose of PTCY at 50mg/kg on day +3 and +4 with same dose of tacrolimus and ATG as the study group.

Вмешательства

• Препарат reduced-dose PTCy
  Patients receiving reduced dose of PTCy at 35mg.kg on day +3 and +4 together with tacrolimus starting from day+5 and single dose of anti-thymoglobin (ATG) 2.5mg/kg at 72 hours after documentation of neutrophil engraftment.
• Препарат Standard dose PTCY
  Patients receiving standard dose PTCy at 50mg/kg on day +3 and +4 with tacrolimus starting from day +5 and single dose of anti-thymoglobin at 2.5mg/kg 72 hours after documentation of neutrophil engraftment.

Первичные конечные точки

• 100-day II-IV acute GVHD [Срок оценки: 100 day]

Вторичные конечные точки (8)

• 100-day acute GVHD [Срок оценки: 100 day]
• 100-day non-relapse mortality [Срок оценки: 100 day]
• 1-year chronic GVHD [Срок оценки: 1 year]
• 1-year moderate to severe chronic GVHD [Срок оценки: 1 year]
• 1-year NRM [Срок оценки: 1 year]
• 1-year cumulated incidence of relapse [Срок оценки: 1 year]
• 1-year overall survival [Срок оценки: 1 year]
• 1-year graft host disease free and relapse free survival [Срок оценки: 1 year]

Критерии участия

Критерии включения

• patients undergo allo-HSCT with matched unrelated donor or haplo-identical donor;
• normal organ function (creatinine clearance ≥ 50ml/min/1.73m2 or creatinine ≤2mg/d(or 177μmol/L); no hepatic abnormal (ALT or AST≤2.5xN; TBil≤1.5XN); Normal pulmonary function (FEV1、 FVC、DLCO≥80%); normal cardiac function (EFS ≥50%);
• ECOG: 0-2;
• Life expectation ≥3 months;
• Informed consent provided.

Критерии исключения

• Pregnancies
• active hepatitis (HBV-DNA≥1×103 copies/ml);
• active infection require anti-biotics;
• HIV infection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Ruijin hsopital — Шанхай

Идентификаторы

NCT: NCT06705062 · PTCY-REDSTAR-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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