A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study of Orelabrutinib in Combination with Rituximab and Bendamustine (BR) Vs. BR in Subjects with Treatment-Naїve Mantle Cell Lymphoma

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Subjects ≥ 65 of age, or ≥ 60 and \< 65 years old who are ineligible for stem cell transplant or have refused stem cell transplantation due to reason(s) including: Have not received prior systemic therapies for MCL.

• Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.

• Histopathological confirmed MCL, expression of Cyclin D1 and/or t (11; 14) chromosomal translocation. Either fresh tissue or FFPE for diagnosis must be sent to central lab for final confirmation after randomization.

• At least one measurable site of disease (the longest axis of the lymph node lesion is \> 1.5 cm, or the longest diameter of the extranodal lesion is \> 1.0 cm).

• ECOG PS score of 0 to 2.

Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Bengbu Medical University
RECRUITING
Bengbu
First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
RECRUITING
Changsha
The First People's Hospital of Changzhou
NOT_YET_RECRUITING
Changzhou
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Chongqinq Cancer Hospital
RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
The second Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Fujing Cancer Hospital
RECRUITING
Fuzhou
Union Hospital Affiliated to Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Zhejiang University Medical School affiliated to the first Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Cancer Hospital of Shandong First Medical University
NOT_YET_RECRUITING
Jinan
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Ningbo University
RECRUITING
Jinan
The First Affiliated Hospital of Henan University of Science & Technology
NOT_YET_RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
NOT_YET_RECRUITING
Nanjing
Cancer Hospital Affiliated to Fudan University
NOT_YET_RECRUITING
Shanghai
Huashan Hospital of Fudan University
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Tianjin Cancer Hospital
RECRUITING
Tianjin
The Tumor Hospital Affiliated to Xinjiang Medical University
RECRUITING
Ürümqi
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
RECRUITING
Wuhan
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
NOT_YET_RECRUITING
Xi'an
The Second Affiliated Hospital Of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Yibin Second People's Hospital
NOT_YET_RECRUITING
Yibin
Henan Cancer Hospital
RECRUITING
Zhengzhou
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Alexia Lu
CO_HGRAC@innocarepharma.com
010-66609745
Time Frame
Start Date: 2024-05-29
Estimated Completion Date: 2032-06-25
Participants
Target number of participants: 476
Treatments
Active_comparator: Arm A
Active_comparator: Arm B
Sponsors
Leads: InnoCare Pharma Inc.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials