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

RecruitingPhase 2Ages 18 Years - anyAllBeijing InnoCare Pharma Tech Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ‰ฅ 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 . Exclusion Criteria * 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.
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What it tests

  • ICP-248
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Where

29 sites
The First Affiliated Hospital of Anhui Medical University
Hefei, China
Peking University Third Hospital
Beijing, China
West China Hospital of Sichuan University
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Chongqing University Cancer Hospital
Chongqing, China
Fujian Medical University Union Hospital
Fuzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Guangdong Provincial People's Hospital
Guangzhou, China

โ€ฆand 21 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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