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Идёт набор NCT06300320

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

Фаза II С лечением Chronic Graft Versus Host Disease

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: TQ05105 tablets.
Кому может быть актуально
Состояния в реестре: Chronic Graft Versus Host Disease. Базовые параметры: 18 лет — 70 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
Китай
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

A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).

Обзор

This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease

Вмешательства

  • Препарат TQ05105 tablets
    Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.

Первичные конечные точки

  • Objective response rate (ORR) at 24 weeks [Срок оценки: Up to 24 weeks]
Вторичные конечные точки (8)
  • Best objective response rate (BOR) [Срок оценки: Up to 48 weeks]
  • Duration of response (DOR) [Срок оценки: Up to 48 weeks]
  • Failure-free survival (FFS) [Срок оценки: Up to 48 weeks]
  • Incidence rate of malignancy relapse or recurrence [Срок оценки: Up to 48 weeks]
  • Non relapse mortality [Срок оценки: At least 48 weeks]
  • Overall Survival (OS) [Срок оценки: At least 48 weeks]
  • Adverse event rate [Срок оценки: Up to 48 weeks]
  • Severity of adverse events (AEs) [Срок оценки: Up to 48 weeks]

Критерии участия

Критерии включения

  • Voluntary and signed informed consent, good compliance;
  • Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months.
  • Received allogeneic hematopoietic stem cell transplantation;
  • Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD)
  • Received systemic therapies for cGVHD;
  • Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening;
  • Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ；platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function;
  • Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study

Критерии исключения

  • Currently present or occured other malignancies within 3 years prior to first administration;
  • Known or suspected active acute graft versus host disease (aGVHD);
  • Presence of infection requiring treatment within 7 days prior to randomization;
  • Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants;
  • Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization;
  • Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc;
  • Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
  • Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment;
  • Have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment;
  • Those who are allergic to the study drug or its components;
  • Participation in other clinical trials or major surgery within 4 weeks prior to the first dose;
  • Subjects judged by the investigator to be unsuitable for enrollment;

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
Лечение

Центры проведения

Китай · 12 центров
  • Anhui Provincial Hospital — Хэфэй
  • The 940th hospital of joint logistics support force of Chinese people's liberation army — Lanzhou
  • Guangzhou First People's Hospital — Гуанчжоу
  • The First Affiliated Hospital of Guangxi Medical University — Nanning
  • The Second Hospital of Hebei Medical University — Shijiazhuang
  • Xiangyang Central Hospital — Xiangyang
  • Tai'an Central Hospital — Taian
  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine — Шанхай
  • … и ещё 4 центра

Идентификаторы

NCT: NCT06300320 · TQ05105-II-06

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗