A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL

December 20, 2024 updated by: InnoCare Pharma Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

476

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Hongmei Jing
      • Beijing, China
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
          • Yuqin Song
      • Bengbu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
          • Yanli Yang
      • Changchun, China
        • Not yet recruiting
        • First Hospital of Jilin University
        • Contact:
          • Ou Bai
      • Changsha, China
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Hui Zhou
      • Changzhou, China
        • Not yet recruiting
        • The First People's Hospital of Changzhou
        • Contact:
          • weiying gu
      • Chengdu, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • xiaobing huang
      • Chengdu, China
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Liqun Zhou
      • Chongqing, China
        • Not yet recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Xiaoqiong Tang
      • Chongqing, China
        • Recruiting
        • Chongqinq Cancer Hospital
        • Contact:
          • Yingyu Nan
      • Dalian, China
        • Not yet recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • Xiuhua Sun
      • Fuzhou, China
        • Not yet recruiting
        • Union Hospital Affiliated to Fujian Medical University
        • Contact:
          • Tingbo Liu
      • Fuzhou, China
        • Recruiting
        • Fujing Cancer Hospital
        • Contact:
          • Hongming He
      • Guangzhou, China
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Zhiming Li
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People'S Hospital
        • Contact:
          • Wenyu Li
      • Hangzhou, China
        • Not yet recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • WenBin Qian
      • Hangzhou, China
        • Recruiting
        • Zhejiang University Medical School affiliated to the first Hospital
        • Contact:
          • Wenjuan Yu
      • Hefei, China
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Jian Ge
      • Jinan, China
        • Not yet recruiting
        • Cancer Hospital of Shandong First Medical University
        • Contact:
          • Zengjun Li
      • Jinan, China
        • Recruiting
        • The first affiliated Hospital of Ningbo University
        • Contact:
          • guifang ouyang
      • Jinan,, China
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Xiaosheng Fang
      • Luoyang, China
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
          • Ling Qin
      • Nanchang, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Fei Li
      • Nanjing, China
        • Not yet recruiting
        • Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
        • Contact:
          • Jingyan Xu
      • Shanghai, China
        • Recruiting
        • Huashan Hospital of Fudan University
        • Contact:
          • Yan Yuan
      • Shanghai, China
        • Not yet recruiting
        • Cancer Hospital Affiliated to Fudan University
        • Contact:
          • Qunling Zhang
      • Shenyang, China
        • Not yet recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
          • Aijun Liao
      • Shenyang, China
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
          • xiaojing Yan
      • Shijiazhuang, China
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
          • Lihong Liu
      • Taiyuan, China
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Liping Su
      • Tianjin, China
        • Recruiting
        • Tianjin Cancer Hospital
        • Contact:
          • Zhengzi Qian
      • Wuhan, China
        • Recruiting
        • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
        • Contact:
          • Liling Zhang
      • Wuhan, China
        • Not yet recruiting
        • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
        • Contact:
          • Jia Kui
      • Wulumuqi, China
        • Recruiting
        • The Tumor Hospital Affiliated to Xinjiang Medical University
        • Contact:
          • Shujuan Wen
      • Xi'an, China
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Wanhong Zhao
      • Xi'an, China
        • Not yet recruiting
        • The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
        • Contact:
          • Guangxun Gao
      • Yibin, China
        • Not yet recruiting
        • Yibin Second People's Hospital
        • Contact:
          • shihua huang
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou
      • Zhengzhou, China
        • Not yet recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • zunmin Zhu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
  3. 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.
  4. 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).
  5. ECOG PS score of 0 to 2.

Exclusion Criteria:

  1. Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
  2. Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
  3. Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
  4. Use of strong inhibitors or strong inducers of cytochrome P450 3A within 14 days or 5 half-lives, whichever is longer, before the first dose of study treatment; or plan to use strong inhibitors or strong inducers of CYP3A during the study.
  5. Known central nervous system lymphoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Drug: Orelabrutinib
Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
Drug: Bendamustine Injection
Eligible patients will receive Bendamustine by injection as per the protocol
Drug: Rituximab
Eligible patients will receive Rituximab by injection as per the protocol
Active Comparator: Arm B
Drug: Bendamustine Injection
Eligible patients will receive Bendamustine by injection as per the protocol
Drug: Rituximab
Eligible patients will receive Rituximab by injection as per the protocol
Drug: Orelabrutinib Placebo
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity (DLT)
Time Frame: 28 days
28 days
Progression-free Survival (PFS) for Arm A vs. Arm B
Time Frame: Approximately 7 years
Approximately 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InnoCare Pharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2024

Primary Completion (Estimated)

June 25, 2031

Study Completion (Estimated)

June 25, 2032

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-CL-00128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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