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NOT YET RECRUITING
NCT07784101
PHASE3

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).

Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

View on ClinicalTrials.gov

Summary

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).

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

280

Start Date

2026-10

Completion Date

2033-12

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DRUG

ICP-248

Administered orally

DRUG

Pirtobrutinib

Administered orally

DRUG

Orelabrutinib

Administered orally

Locations (24)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Xinqiao Hospital of Army Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

Nanjing, Jiangsu, China

The first Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xian, Shanxi, China

The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)

Xian, Shanxi, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China