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Идёт набор NCT05976997

Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)

Фаза II С лечением Newly Diagnosed Peripheral T-cell 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: Duvelisib, Chidamide.
Кому может быть актуально
Состояния в реестре: Newly Diagnosed Peripheral T-cell Lymphoma. 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
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Обзор

This is a prospective, single arm, single center study to evaluate the efficacy and safety of Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell lymphoma.

Подробное описание

This is a prospective, single arm, single center study, including two phases. It plans to recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether the efficacy reaches CR in the second phase.

Вмешательства

  • Препарат Duvelisib, Chidamide
    Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;

Первичные конечные точки

  • Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0) [Срок оценки: from the initiation of the first dose to 28 days after the last dose]
Вторичные конечные точки (5)
  • Objective response rate (ORR) [Срок оценки: up to 26 weeks]
  • Complete remission rate (CR) [Срок оценки: up to 26 weeks]
  • Duration of Response（DOR） [Срок оценки: The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause)，assessed up to 12 months]
  • Progression free survival (PFS) [Срок оценки: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months]
  • Overall survival (OS) [Срок оценки: From date of randomization until the date of death from any cause, assessed up to 20 months]

Критерии участия

Критерии включения

\-

1.Age: 18-70 Years (Contains boundary values 18 and 70);

  • 2.The newly diagnosed PTCL confirmed by histopathology is one of the following subtypes;

a) Angioimmunoblastic T-cell lymphoma (AITL); b) Follicular T helper cell lymphoma (T-FHCL); Including but not limited to the above two subtypes;

  • 3.ECOG ≤ 3;
  • 4.At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard;
  • 5.Expected survival ≥ 3 months;
  • 6.Subjects fully understand and voluntarily participate in this study and sign informed consent;

Критерии исключения

\-

1.Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment;

  • 2.Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS;
  • 3.Significant active heart disease within the past 6 months, including: New York Heart Association (NYHA) Class III/IV congestive heart failure unstable angina pectoris or angina requiring surgical or medication intervention, and/or myocardial infarction;
  • 4.Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments);
  • 5.Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection and history of severe skin reaction;
  • 6.Subjects with any other active malignant tumor at the time of screening, except for adequately treated cervical Carcinoma in situ or breast cancer Carcinoma in situ, skin Basal-cell carcinoma or local skin squamous cell carcinoma;
  • 7.Pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study;
  • 8.Any serious uncontrolled systemic disease;
  • 9.increasing the risk of the subject or interfering with the test results determined by the investigator;

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 · 1 центр
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT05976997 · CSPC-KBT-PTCL-C01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗