Evaluating Different Doses of Orelabrutinib in MCL
A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma
1 other identifier
interventional
40
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2023
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 7, 2023
CompletedStudy Start
First participant enrolled
August 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2025
CompletedOctober 25, 2023
October 1, 2023
1.5 years
July 11, 2023
October 24, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate（ORR）
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 Outcomes (10)
Complete Response Rate （CRR）
Through study completion, an average of 2 year
Progression-Free Survival (PFS)
Through study completion, an average of 2 year
Duration of Response (DoR)
Through study completion, an average of 2 year
Maximum concentration (Cmax,ss)
Predose up to 24 hours postdose
Time to maximum concentration (Tmax)
Predose up to 24 hours postdose
- +5 more secondary outcomes
Study Arms (2)
Orelabrutinib high dose
EXPERIMENTALOrelabrutinib low dose
EXPERIMENTALInterventions
Orelabrutinib will be administered as 3 tablets once per day
Orelabrutinib will be administered as 1 tablet once per day
Eligibility Criteria
You may qualify if:
- Male and female subjects ≥ 18 years of age.
- Mantle cell lymphoma (MCL) confirmed by histopathology.
- Subjects who have not previously received standard systemic care and relapsing/refractory subjects who have previously received standard systemic care.
- At least one measurable lesion.
- ECOG Physical fitness score 0-2 points.
- Expected survival time ≥ 4 months.
- Full hematology function.
- Blood clotting function is basically normal.
- Subjects with basically normal liver, kidney and heart function.
- Subject voluntarily signs a written ICF.
- The serum pregnancy test of female subjects with fertility potential was negative within 7 days before the first dosing.
- 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.
You may not qualify if:
- Adequate treatment with BTK inhibitors.
- Have a history of severe allergic disease and a history of severe drug allergy.
- Subjects who have received the treatment or drug restricted in the protocol within the time specified for the first use of the investigational drug.
- 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.
- History of other active malignant diseases within 2 years prior to screening.
- Subjects with systemic bacterial, viral, fungal (other than nail fungal infections) or parasitic infections with poorly controlled activity.
- Indicates active hepatitis B or C virus infection.
- There are diseases that are excluded from the criteria in the programme.
- Toxicity of previous anticancer therapy was still ≥ grade 2 at the start of study therapy (according to CTCAE V5.0).
- History of severe bleeding disorder.
- People with a known history of alcohol or drug abuse.
- Subjects with mental disorders or poor compliance.
- Pregnant or lactating female subjects.
- Other conditions deemed unsuitable for participation in this study by the investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InnoCare Pharma Inc.lead
- Beijing InnoCare Pharma Tech Co., Ltd.collaborator
Study Sites (20)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233040, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, 510055, China
Nanyang Second General Hospital
Nanyang, Henan, 473009, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
Chenzhou First People's Hospital
Chenzhou, Hunan, 423003, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Uygur Autonomous Region, 830000, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2023
First Posted
August 7, 2023
Study Start
August 18, 2023
Primary Completion
February 25, 2025
Study Completion
May 25, 2025
Last Updated
October 25, 2023
Record last verified: 2023-10