Mantle Cell LymphomaPhase 2NCT05978739
Evaluating Different Doses of Orelabrutinib in MCL
A Phase 2 study testing Orelabrutinib High dose and Orelabrutinib Low dose in people with Mantle Cell Lymphoma, run by InnoCare Pharma Inc. at 20 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Orelabrutinib High dose and Orelabrutinib Low dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 20 sitesChina
- Study dates
- 18 Aug 2023to 10 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
China20 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233040
Hunan Cancer Hospital
Changsha, Hunan, 410031
Chenzhou First People's Hospital
Chenzhou, Hunan, 423003
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou, 510055
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Nanyang Second General Hospital
Nanyang, Henan, 473009
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
The Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Uygur Autonomous Region, 830000
Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Hubei Cancer Hospital
Wuhan, Hubei, 430079
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710004
Henan Cancer Hospital
Zhengzhou, Henan, 450003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: 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.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Orelabrutinib High dose, Orelabrutinib Low dose
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib High doseDrug
Orelabrutinib will be administered as 3 tablets once per day
Orelabrutinib Low doseDrug
Orelabrutinib will be administered as 1 tablet once per day
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib high dose | Experimental | Not described Receives: Drug: Orelabrutinib High dose |
| Orelabrutinib low dose | Experimental | Not described Receives: Drug: Orelabrutinib Low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate（ORR）
Proportion of subjects with tumor response of Complete Response（CR） or Partial Response（PR） after treatment in total subjects.
Measured: Through study completion, an average of 2 year
Secondary outcomes (10)
Complete Response Rate （CRR）
The proportion of subjects with tumor response of Complete Response（CR） after treatment in total subjects.
Measured: Through study completion, an average of 2 year
Progression-Free Survival (PFS)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first.
Measured: Through study completion, an average of 2 year
Duration of Response (DoR)
The time from documentation of objective response to the first occurrence of tumor progression or death due to any cause, whichever occurs first.
Measured: Through study completion, an average of 2 year
Maximum concentration (Cmax,ss)
Measured: Predose up to 24 hours postdose
Time to maximum concentration (Tmax)
Measured: Predose up to 24 hours postdose
Area under the plasma concentration-time curve (AUC)
Measured: Predose up to 24 hours postdose
Half-life (T1/2)
Measured: Predose up to 24 hours postdose
Apparent clearance (CL/F)
Measured: Predose up to 24 hours postdose
Adverse events（AEs）
Measured: Through study completion, an average of 2 year
Serious adverse events （SAEs）
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start18 Aug 2023
- Primary completion10 Dec 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- InnoCare Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing InnoCare Pharma Tech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978739
- Sponsor's protocol ID
- ICP-CL-00127
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2023
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Open-label, Multicenter, Phase II Trial Evaluating Two Different Doses of Orelabrutinib in Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05978739
- Acronym / sponsor ID
- ICP-CL-00127
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- InnoCare Pharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- Beijing InnoCare Pharma Tech Co., Ltd.
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib high dose | Experimental | Drug: Orelabrutinib High dose |
| Orelabrutinib low dose | Experimental | Drug: Orelabrutinib Low dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orelabrutinib High doseOrelabrutinib will be administered as 3 tablets once per day | Drug | Orelabrutinib high dose |
| Orelabrutinib Low doseOrelabrutinib will be administered as 1 tablet once per day | Drug | Orelabrutinib low dose |
Primary outcome
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.
10 secondary outcomes
Complete Response Rate （CRR）
Time frame: Through study completion, an average of 2 year
Progression-Free Survival (PFS)
Time frame: Through study completion, an average of 2 year
Duration of Response (DoR)
Time frame: Through study completion, an average of 2 year
Maximum concentration (Cmax,ss)
Time frame: Predose up to 24 hours postdose
Time to maximum concentration (Tmax)
Time frame: Predose up to 24 hours postdose
Area under the plasma concentration-time curve (AUC)
Time frame: Predose up to 24 hours postdose
Half-life (T1/2)
Time frame: Predose up to 24 hours postdose
Apparent clearance (CL/F)
Time frame: Predose up to 24 hours postdose
Adverse events（AEs）
Time frame: Through study completion, an average of 2 year
Serious adverse events （SAEs）
Time frame: Through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Orelabrutinib High dose and Orelabrutinib Low dose in people with Mantle Cell Lymphoma, run by InnoCare Pharma Inc. at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate（ORR） (time frame: Through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.