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).
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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Known intolerance to orelabrutinib or pirtobrutinib treatment.
2. 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.
3. Patients with other malignancies within 2 years prior to enrollment.
4. Uncontrolled or significant cardiovascular disease.
5. 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.
6. Participants with severe central nervous system diseases.
7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
8. Underwent major surgery within 4 weeks prior to the first dose.
9. Active infections require systemic treatment.
10. Active autoimmune diseases.
11. Known central nervous system lymphoma.
12. Known alcohol or drug dependence.
Exclusion Criteria:
1. Known intolerance to orelabrutinib or pirtobrutinib treatment.
2. 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.
3. Patients with other malignancies within 2 years prior to enrollment.
4. Uncontrolled or significant cardiovascular disease.
5. 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.
6. Participants with severe central nervous system diseases.
7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
8. Underwent major surgery within 4 weeks prior to the first dose.
9. Active infections require systemic treatment.
10. Active autoimmune diseases.
11. Known central nervous system lymphoma.
12. Known alcohol or drug dependence.
Primary outcome measure(s)
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC). — 6 years
Trial sites (24)
Facility
City
Region
Status
The First Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Peking University Third Hospital
Beijing
Beijing Municipality
Chongqing University Cancer Hospital
Chongqing
Chongqing Municipality
Xinqiao Hospital of Army Medical University
Chongqing
Chongqing Municipality
Fujian Cancer Hospital
Fuzhou
Fujian
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Hebei
Henan Cancer Hospital
Zhengzhou
Henan
Henan Provincial People's Hospital
Zhengzhou
Henan
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Hubei
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Wuhan
Hubei
Hunan Cancer Hospital
Changsha
Hunan
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing
Jiangsu
The first Hospital of China Medical University
Shenyang
Liaoning
Shandong Cancer Hospital
Jinan
Shandong
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian
Shanxi
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
Xian
Shanxi
Sichuan Cancer Hospital
Chengdu
Sichuan
West China Hospital of Sichuan University
Chengdu
Sichuan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
Yunnan Cancer Hospital
Kunming
Yunnan
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
Zhejiang Cancer Hospital
Hangzhou
Zhejiang
More Beijing InnoCare Pharma Tech Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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