Evaluating Different Doses of Orelabrutinib in MCL

October 24, 2023 updated by: InnoCare Pharma Inc.

A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma

This is A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma to Evaluate the Efficacy and Safety in Mantle Cell Lymphoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

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
    • Anhui
      • Bengbu, Anhui, China, 233040
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Yanli Yang
      • Hefei, Anhui, China, 230022
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Qingshu Zeng
    • Beijing
      • Beijing, Beijing, China, 100191
        • Not yet recruiting
        • Peking University Third Hospital
        • Contact:
          • Hongmei Jing
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing Cancer Hospital
        • Contact:
          • Jieping Li
    • Guangzhou
      • Guangdong, Guangzhou, China, 510055
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
          • Zhiming Li
    • Henan
      • Nanyang, Henan, China, 473009
        • Not yet recruiting
        • Nanyang second general hospital
        • Contact:
          • Jinxiao Yao
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Zhihua Yao
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Lei Zhang
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
        • Contact:
          • Huijing Wu
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Guohui Cui
    • Hunan
      • Changsha, Hunan, China, 410031
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Hui Zhou
      • Chenzhou, Hunan, China, 423003
        • Recruiting
        • Chenzhou First People's Hospital
        • Contact:
          • Xinquan Liang
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Wuping Li
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Li Yu
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • Xiuhua Sun
      • Shenyang, Liaoning, China, 110001
        • Recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
          • Xiaojing Yan
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Not yet recruiting
        • Shanxi Provincial Cancer Hospital
        • Contact:
          • Liping Su
      • Xi'an, Shanxi, China, 710004
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Jianli Wang
    • Uygur Autonomous Region
      • Urumqi, Uygur Autonomous Region, China, 830000
        • Recruiting
        • The Affiliated Cancer Hospital of XinJiang Medical University
        • Contact:
          • Shujuan Wen
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:
          • Wenjuan Yu

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. Male and female subjects ≥ 18 years of age.
  2. Mantle cell lymphoma (MCL) confirmed by histopathology.
  3. Subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care.
  4. At least one measurable lesion.
  5. ECOG Physical fitness score 0-2 points.
  6. Expected survival time ≥ 4 months.
  7. Full hematology function.
  8. Blood clotting function is basically normal.
  9. Subjects with basically normal liver, kidney and heart function.
  10. Subject voluntarily signs a written ICF.
  11. The serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing.
  12. Female subjects with reproductive potential or male subjects and their partners must agree to use effective contraception for at least 6 months from signing the ICF until the last dose of the study drug.

Exclusion Criteria:

  1. Adequate treatment with BTK inhibitors.
  2. Have a history of severe allergic disease and a history of severe drug allergy.
  3. Subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug.
  4. The last use of a potent CYP3A inhibitor or potent CYP3A inducer (including food, western medicine, and Chinese medicine) was less than 2 weeks (or less than 5 half-lives, depending on the time) from the first trial, or plan to take a potent CYP3A inhibitor or potent CYP3A inducer drug or food during the study period.
  5. History of other active malignant diseases within 2 years prior to screening.
  6. Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity.
  7. Indicates active hepatitis B or C virus infection.
  8. There are diseases that are excluded from the criteria in the programme.
  9. Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study therapy (according to CTCAE V5.0).
  10. History of severe bleeding disorder.
  11. People with a known history of alcohol or drug abuse.
  12. Subjects with mental disorders or poor compliance.
  13. Pregnant or lactating female subjects.
  14. Other conditions deemed unsuitable for participation in this study by the investigator.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orelabrutinib high dose
Drug: Orelabrutinib High dose
Orelabrutinib will be administered as 3 tablets once per day
Experimental: Orelabrutinib low dose
Drug: Orelabrutinib Low dose
Orelabrutinib will be administered as 1 tablet once per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate（ORR）
Time Frame: Through study completion, an average of 2 year
Proportion of subjects with tumor response of Complete Response（CR） or Partial Response（PR） after treatment in total subjects.
Through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate （CRR）
Time Frame: Through study completion, an average of 2 year
The proportion of subjects with tumor response of Complete Response（CR） after treatment in total subjects.
Through study completion, an average of 2 year
Progression-Free Survival (PFS)
Time Frame: Through study completion, an average of 2 year
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Through study completion, an average of 2 year
Duration of Response (DoR)
Time Frame: Through study completion, an average of 2 year
The time from documentation of objective response to the first occurrence of tumor progression or death due to any cause, whichever occurs first.
Through study completion, an average of 2 year
Maximum concentration (Cmax,ss)
Time Frame: Predose up to 24 hours postdose
Predose up to 24 hours postdose
Time to maximum concentration (Tmax)
Time Frame: Predose up to 24 hours postdose
Predose up to 24 hours postdose
Area under the plasma concentration-time curve (AUC)
Time Frame: Predose up to 24 hours postdose
Predose up to 24 hours postdose
Half-life (T1/2)
Time Frame: Predose up to 24 hours postdose
Predose up to 24 hours postdose
Apparent clearance (CL/F)
Time Frame: Predose up to 24 hours postdose
Predose up to 24 hours postdose
Adverse events（AEs）
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year
Serious adverse events （SAEs）
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year

Collaborators and Investigators

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

Sponsor

InnoCare Pharma Inc.

Collaborators

Beijing InnoCare Pharma Tech Co., Ltd.

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)

August 18, 2023

Primary Completion (Estimated)

February 25, 2025

Study Completion (Estimated)

May 25, 2025

Study Registration Dates

First Submitted

July 11, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-CL-00127

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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