Mini-dose MTX Plus Standard-dose Steroid for the Initial Treatment of Acute GVHD

Официальное название

Randomized Trial of Mini-dose Methotrexate Plus Standard-dose Steroid vs Steroids for the Initial Treatment of Acute Graft Versus Host Disease

Обзор

This trial is a randomized (1:1) phase III open label study of frontline mini-MTX plus methylprednisolone 2mg/kg/day compared to methylprednisolone 2mg/kg in allogeneic stem cell transplant recipients with grade 2-4 aGVHD.

Подробное описание

Allo-HSCT is an effective treatment of malignant hematopoietic diseases. However, aGVHD remains a major complication after allo-HSCT. Corticosteroid is the standard first-line therapy for aGVHD. However, the response rate of corticosteroid was approximate 50%, and the clinical outcomes of patients with corticosteroid refractory GVHD were poor. Thus far, no combination therapy had been prove to be superior to corticosteroid alone as initial therapy for aGVHD. The study hypothesis: MTX combined corticosteroid treatment could help to control aGVHD.

Вмешательства

• Препарат MTX
  MTX (5mg/m\^2/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR
• Препарат Corticosteroid
  Corticosteroid Methylprednisolone 2 mg/kg/day was given for 3 days, and for responding patients, the dose of prednisone must be at least 0.25mg/kg/day prednisone (or 0.2mg/kg/day methylprednisolone).

Первичные конечные точки

• Overall response rate (ORR) for aGVHD treatment after treatment [Срок оценки: 14 days]

Вторичные конечные точки (9)

• Overall response rate (ORR) for aGVHD treatment at 28 days after treatment [Срок оценки: 28 days]
• Overall response rate (ORR) for aGVHD treatment at 42 days after treatment [Срок оценки: 42 days]
• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: 42 days]
• cGVHD [Срок оценки: 1 years]
• Infection and poor graft function [Срок оценки: 1 year]
• Relapse [Срок оценки: 1 year]
• Non-relapse mortality [Срок оценки: 1 year]
• Overall survival [Срок оценки: 1 year]
• Disease free survival [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Patients who are fully informed and sign informed consent by themselves or their guardians;
• Patients receiving first allogeneic hematopoietic stem cell transplantation;
• Patients with acute graft-versus-host disease of grade II-IV were diagnosed after transplantation;
• KPS>60, Estimated survival >3 months;
• No serious organ damage:

• ANC in peripheral blood is greater than 0.5×109/l
• Creatinine < 1.5mg/dl
• Cardiac ejection index > 55%

Критерии исключения

• Patients with severe brain, heart, kidney or liver dysfunction unrelated to graft-versus host disease;
• Patients with uncontrollable active infection;
• Patients with recurrence of primary malignant hematopathy;
• Expected survival is less than 3 months
• Patients who have histories of severe allergic reactions
• Pregnant or lactating women
• The researcher judges that there are other factors that are not suitable for participating
• Patients who received donor lymphocyte infusion

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

Лечение

Центры проведения

Китай · 2 центра

• Peking University Institute of Hematology, — Пекин
• Nanfang Hospital, Nanfang Medical University — Гуанчжоу

Идентификаторы

NCT: NCT05921305 · GVHD-MTX-Randomized trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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