ICP-248 With Orelabrutinib Versus Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
Compares two treatments in adults whose mantle cell lymphoma returned or did not respond.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).
Key facts
- Where
- Beijing, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Hefei, Jinan, Kunming, Nanjing, Shanghai, Shenyang, Shijiazhuang, Tianjin, Wuhan, Xian, and Zhengzhou, ChinaSee the 24 sites
- Phase
- Phase 3
Where in China
- Peking University Third HospitalBeijing, ChinaNo longer taking part
- Hunan Cancer HospitalChangsha, ChinaNo longer taking part
- Sichuan Cancer HospitalChengdu, ChinaNo longer taking part
- West China Hospital of Sichuan UniversityChengdu, ChinaNo longer taking part
- Chongqing University Cancer HospitalChongqing, ChinaNo longer taking part
- Xinqiao Hospital of Army Medical UniversityChongqing, ChinaNo longer taking part
- Fujian Cancer HospitalFuzhou, ChinaNo longer taking part
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- Zhejiang Cancer HospitalHangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaNo longer taking part
- Shandong Cancer HospitalJinan, ChinaNo longer taking part
- Yunnan Cancer HospitalKunming, ChinaNo longer taking part
- Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing UniversityNanjing, ChinaNo longer taking part
- Fudan University Shanghai Cancer CenterShanghai, ChinaNo longer taking part
- The First Hospital of China Medical UniversityShenyang, ChinaNo longer taking part
- The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaNo longer taking part
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesTianjin, ChinaNo longer taking part
- Huazhong University of Science and Technology Tongji Medical College Affiliated Union HospitalWuhan, ChinaNo longer taking part
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
- The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)Xian, ChinaNo longer taking part
- The Second Affiliated Hospital Of Xi'an Jiaotong UniversityXian, ChinaNo longer taking part
- Henan Cancer HospitalZhengzhou, ChinaNo longer taking part
- Henan Provincial People's HospitalZhengzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Beijing InnoCare Pharma Tech Co., Ltd.
- Trial code
- NCT07784101
- Record updated
- 25 August 2026
- Original description
This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).Read full original descriptionShow less
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL)
This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).
Inclusion: Known intolerance to orelabrutinib or pirtobrutinib treatment; Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past; Patients with other malignancies within 2 years prior to enrollment; Uncontrolled or significant cardiovascular disease; Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding; Participants with severe central nervous system diseases; Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy; Underwent major surgery within 4 weeks prior to the first dose; Active infections require systemic treatment; Active autoimmune diseases; Known central nervous system lymphoma; Known alcohol or drug dependence.
Exclusion: Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past; Patients with other malignancies within 2 years prior to enrollment; Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy; Underwent major surgery within 4 weeks prior to the first dose; Known alcohol or drug dependence; Uncontrolled or significant cardiovascular disease; Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding; Participants with severe central nervous system diseases; Active infections require systemic treatment; Active autoimmune diseases; Known intolerance to orelabrutinib or pirtobrutinib treatment; Known central nervous system lymphoma.