Treatment-naїve Mantle Cell LymphomaPhase 3NCT05051891
A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma
A Phase 3 study testing Orelabrutinib and R-CHOP and R-CHOP in people with Treatment-naїve Mantle Cell Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 22 sites in China.
Trial summary
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Treatment-naїve Mantle Cell Lymphoma
- What is being tested?
- Orelabrutinib and R-CHOP and R-CHOP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 22 sitesChina
- Study dates
- 22 Dec 2021to 30 Jun 2025
- Phase
- Phase 3
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
- Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
- No previous systemic treatment for MCL.
- ECOG physical strength score is 0-2.
- Expected survival time >6 months.
- Voluntary written informed consent prior to screening.
Who cannot join
- Uncontrolled or significant cardiovascular diseases
- History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
- Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
- Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
- Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
China22 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100143
The First Hospital of Jilin University
Changchun, Jilin, 130021
West China Hospital,Sichuan University
Chengdu, Sichuan, 610041
The First Affiliated Hospital of Guangxi Medical University
Guangxi, Nanning, 530021
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
he First Affiliated Hospital of Zhengjiang University
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Anhui Province Cancer Hospital
Hefei, Anhui, 230009
Tumor in Hunan Province
Hunan, Changsha, 410013
Shandong Provincial Hospital
Jinan, Shandong, 250021
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 3300008
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
The First Hospital of China Medical University
Shenyang, Liaojing, 110001
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50011
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300052
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Wuhan Union Hospital
Wuhan, Hubei, 430022
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Henan Tumor Hospital
Zhengzhou, Henan, 450008
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.
- Conditions
- Treatment-naїve Mantle Cell Lymphoma
- Being tested
- Orelabrutinib and R-CHOP, R-CHOP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orelabrutinib and R-CHOPDrug
Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
R-CHOPDrug
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) Receives: Drug: Orelabrutinib and R-CHOP |
| The control group | Experimental | R-CHOP Receives: Drug: R-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
To evaluate the Progression-free Survival (PFS) by the Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL).
Measured: Up to 6 years
Secondary outcomes (3)
ORR
Objective Response Rate
Measured: Up to 6 years
CRR
Complete Response Rate
Measured: Up to 6 years
OS
Overall Survival
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start22 Dec 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-naїve 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051891
- Sponsor's protocol ID
- ICP-CL-00113
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05051891
- Acronym / sponsor ID
- ICP-CL-00113
- Conditions
- Treatment-naїve Mantle Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 21 Sep 2021 (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.
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve 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 |
|---|---|---|
| the experimental group | Experimental | Drug: Orelabrutinib and R-CHOPOrelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) |
| The control group | Experimental | Drug: R-CHOPR-CHOP |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 65 < age <80, or 60 ≤ age ≤65 and is ineligible for autologous stem cell transplantation as assessed by the investigator
- Histopathological confirmed MCL and either expression of cyclin D1 or t (11;14) chromosomal translocation (in association with CD20). The verification will be based on central review of the local pathology report.
- No previous systemic treatment for MCL.
- ECOG physical strength score is 0-2.
- Expected survival time >6 months.
Key exclusion criteria (6 listed)
- Uncontrolled or significant cardiovascular diseases
- History of stroke or intracranial hemorrhage within 6 months before first administration of study treatment.
- Any mental or cognitive impairments which may limit the subject 's understanding and execution of informed consent as well as study compliance;
- Pregnant or breastfeeding women and those who do not agree to take contraceptive measures.
- Conditions in which a potentially life-threatening illness or severe organ dysfunction is not considered appropriate by the investigator.
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 and R-CHOPOrelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) | Drug | the experimental group |
| R-CHOPRituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) | Drug | The control group |
Primary outcome
PFS
Time frame: Up to 6 years
To evaluate the Progression-free Survival (PFS) by the Independent Review Committee (IRC) according to the 2014 International Working Group Criteria for Non-Hodgkin Lymphoma (iwNHL).
3 secondary outcomes
ORR
Time frame: Up to 6 years
CRR
Time frame: Up to 6 years
OS
Time frame: Up to 6 years
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 31 Mar 2026.
Related trials for Treatment-naїve Mantle Cell Lymphoma
RecruitingPhase 3
A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
Mantle Cell Lymphoma
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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Orelabrutinib and R-CHOP and R-CHOP in people with Treatment-naїve Mantle Cell Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 22 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 6 inclusion and 6 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 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
PFS (time frame: Up to 6 years). 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 31 Mar 2026.