A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)

Официальное название

A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Обзор

This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.

Вмешательства

• Препарат ICP-248
  Eligible patients will receive ICP-248 orally as per the protocol

Первичные конечные точки

• Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC) [Срок оценки: 3 years]

Вторичные конечные точки (12)

• According to Lugano 2014: IRC and investigator assessed complete response rate (CRR) [Срок оценки: 3 years]
• Investigator-assessed ORR [Срок оценки: 3 years]
• According to Lugano 2014: IRC and investigator assessed disease control rate (DCR). [Срок оценки: 3 years]
• According to Lugano 2014: IRC and investigator assessed duration of response (DOR). [Срок оценки: 3 years]
• According to Lugano 2014: IRC and investigator assessed time to initial response (TTR). [Срок оценки: 3 years]
• According to Lugano 2014: IRC and investigator assessed progression-free survival (PFS) . [Срок оценки: 3 years]
• Overall survival (OS) [Срок оценки: 3 years]
• Adverse event (AE) assessed according to CTCAE v5.0 criteria [Срок оценки: 3 years]
• Functional Assessment Of Cancer Therapy-Lymphoma (Fact-Lym) and European Quality Of Life Five Dimension Five Level Scale Questionnaire (Eq-5D-5L). [Срок оценки: 3 years]
• Area under the plasma concentration versus time curve (AUC) [Срок оценки: 3 years]
• minimal residual disease （MRD） status [Срок оценки: 3 years]
• Peak Plasma Concentration (Cmax) [Срок оценки: 3 years]

Критерии участия

Критерии включения

• ≥ 18 years old.
• Histopathologically confirmed MCL expressing Cyclin D1 and/or t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory.
• The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements:

• Failure of at least one adequate prior line of anti-CD20-containing therapy;
• Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy.
• Failure of the last line of therapy.
• At least one measurable lesion according to the Lugano 2014 criteria,.
• ECOG performance status of 0-2 .

Критерии исключения

• Current or prior history of central nervous system (CNS) lymphoma.
• Prior use of BCL-2 inhibitors (e.g., venetoclax/ABT-199, etc.).
• Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-248.
• Prior allogeneic hematopoietic stem cell transplantation.

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 · 29 центров

• The First Affiliated Hospital of Anhui Medical University — Хэфэй
• Peking University Third Hospital — Пекин
• West China Hospital of Sichuan University — Чэнду
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Chongqing University Cancer Hospital — Чунцин
• Fujian Medical University Union Hospital — Фучжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• … и ещё 21 центр

Идентификаторы

NCT: NCT07082686 · ICP-CL-01206

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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