Anti-CD25 rhMAb for aGVHD Prevention in High-Risk Adults Using the daGOAT Model

Официальное название

A Prospective, Single-arm, Historically Controlled, Single-center Study for Preventing aGVHD, Post-allogeneic HSCT, in Adults at Moderate-to-high Risk Using Recombinant Humanized Anti-CD25 Monoclonal Antibody Based on the daGOAT Model

Обзор

To assess the efficacy and safety of using recombinant humanized anti-CD25 monoclonal antibody injection as a prophylactic strategy for reducing the incidence of severe acute graft-versus-host disease (aGVHD) in adult patients at intermediate to high risk, as predicted by the dynamic aGVHD Onset Anticipation Tianjin (daGOAT) model, following allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Вмешательства

• Препарат Recombinant Humanized Anti-CD25 Monoclonal Antibody Injection
  Model-predicted patients at high risk (HR): Recombinant humanized anti-CD25 monoclonal antibody: 50 mg/day when the post-transplant model predicts high risk in the second week post-prediction and 25 mg/day in the fourth and sixth weeks post-prediction. Administered in combination with conventional aGVHD prevention regimen. Model-predicted patients at moderate risk (MR): Recombinant anti-CD25 humanized monoclonal antibody: 25 mg/day when the model predicts intermediate risk post-transplantation

Первичные конечные точки

• Incidence of severe aGVHD (Grade III-IV) within 100 days post-transplantation [Срок оценки: 100 days after transplantation]

Вторичные конечные точки (11)

• Incidence of aGVHD and aGVHD (any grade) in each target organ within 100 days post-transplantation [Срок оценки: 100 days after transplantation]
• Engraftment rate [Срок оценки: 180 days after transplantation]
• Disease relapse rate [Срок оценки: 180 days after transplantation]
• Infection rate [Срок оценки: 180 days after transplantation]
• Overall survival [Срок оценки: 180 days after transplantation]
• Non-relapse mortality [Срок оценки: 180 days after transplantation]
• GVHD-free relapse-free survival [Срок оценки: 180 days after transplantation]
• Overall Response Rate of severe aGVHD treatment [Срок оценки: 100 days after transplantation]
• Incidence of chronic GVHD [Срок оценки: 180 days after transplantation]
• Adverse events [Срок оценки: 180 days after transplantation]
• Total cost of treatment [Срок оценки: 180 days after transplantation]

Критерии участия

Критерии включения

• Age ≥ 16 years, regardless of gender.
• Patients with hematologic disorders who are scheduled to receive allo-HSCT.
• Voluntarily join this study, sign the informed consent form, have good compliance, and be willing to cooperate with follow-up.

Критерии исключения

• Patients who have received a second or multiple transplants.
• Patients who are allergic to, or intolerant of, a recombinant humanized anti-CD25 monoclonal antibody injection.
• Pregnant or lactating female patients or female patients who are unable to take effective contraceptive measures during the entire trial period.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Institute of Hematology & Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT06880419 · IIT2024115

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗