Mantle Cell LymphomaPhase 3NCT06363994
A Global Phase 3 Study of Orelabrutinib+BR Vs.BR in Pts with TN MCL
A Phase 3 study testing Orelabrutinib, Bendamustine Injection and Rituximab in people with Mantle Cell Lymphoma, run by InnoCare Pharma Inc. at 39 sites in China.
Trial summary
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL) Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Orelabrutinib, Bendamustine Injection and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 476 participants
- Where
- 39 sitesChina
- Study dates
- 29 May 2024to 25 Jun 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
- 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.
- 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).
- ECOG PS score of 0 to 2.
Who cannot join
- Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
- Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
- Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
- 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.
- Known central nervous system lymphoma.
Trial locations and contacts
39 sites in 1 country. Contact the study team or a site near you to ask about taking part.
39 sites in 1 country
China39 sites, 39 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Yuqin Song
- Recruiting
Peking University Third Hospital
Beijing
Hongmei Jing
- Recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu
Yanli Yang
- Not yet recruiting
First Hospital of Jilin University
Changchun
Ou Bai
- Recruiting
Hunan Cancer Hospital
Changsha
Hui Zhou
- Not yet recruiting
The First People's Hospital of Changzhou
Changzhou
Weiying Gu
- Recruiting
Sichuan Provincial People's Hospital
Chengdu
Xiaobing Huang
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu
Liqun Zhou
- Recruiting
Chongqinq Cancer Hospital
Chongqing
Yingyu Nan
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Xiaoqiong Tang
- Not yet recruiting
The second Hospital of Dalian Medical University
Dalian
Xiuhua Sun
- Recruiting
Fujing Cancer Hospital
Fuzhou
Hongming He
- Not yet recruiting
Union Hospital Affiliated to Fujian Medical University
Fuzhou
Tingbo Liu
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Wenyu Li
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
Zhiming Li
- Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Wenbin Qian
- Recruiting
Zhejiang University Medical School affiliated to the first Hospital
Hangzhou
Wenjuan Yu
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei
Jian Ge
- Not yet recruiting
Cancer Hospital of Shandong First Medical University
Jinan
Zengjun Li
- Not yet recruiting
Shandong Provincial Hospital
Jinan
Xiaosheng Fang
- Recruiting
The First Affiliated Hospital of Ningbo University
Jinan
Guifang Ouyang
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang
Ling Qin
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang
Fei Li
- Not yet recruiting
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing
Jingyan Xu
- Not yet recruiting
Cancer Hospital Affiliated to Fudan University
Shanghai
Qunling Zhang
- Recruiting
Huashan Hospital of Fudan University
Shanghai
Yan Yuan
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang
Aijun Liao
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang
Xiaojing Yan
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Lihong Liu
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan
Liping Su
- Recruiting
Tianjin Cancer Hospital
Tianjin
Zhengzi Qian
- Recruiting
The Tumor Hospital Affiliated to Xinjiang Medical University
Ürümqi
Shujuan Wen
- Recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan
Liling Zhang
- Not yet recruiting
Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and
Wuhan
Jia Kui
- Not yet recruiting
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
Xi'an
Guangxun Gao
- Not yet recruiting
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an
Wanhong Zhao
- Not yet recruiting
Yibin Second People's Hospital
Yibin
Shihua Huang
- Recruiting
Henan Cancer Hospital
Zhengzhou
Keshu Zhou
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou
Zunmin Zhu
About this study
Official title: 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)
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Orelabrutinib, Bendamustine Injection, Rituximab, Orelabrutinib Placebo
- 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.
OrelabrutinibDrug
Eligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first.
Bendamustine InjectionDrug
Eligible patients will receive Bendamustine by injection as per the protocol
RituximabDrug
Eligible patients will receive Rituximab by injection as per the protocol
Orelabrutinib PlaceboDrug
Eligible patients will receive Orelabrutinib Placebo orally as per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Active comparator | Not described Receives: Drug: Orelabrutinib; Drug: Bendamustine Injection; Drug: Rituximab |
| Arm B | Active comparator | Not described Receives: Drug: Bendamustine Injection; Drug: Rituximab; Drug: Orelabrutinib Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: 28 days
Progression-free Survival (PFS) for Arm A vs. Arm B
Measured: Approximately 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start29 May 2024
- Primary completion25 Jun 2031 (estimated)
- Study completion25 Jun 2032 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 476 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoCare Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363994
- Sponsor's protocol ID
- ICP-CL-00128
- Status last verified
- Dec 2024
- First submitted
- 9 Apr 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06363994
- Acronym / sponsor ID
- ICP-CL-00128
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 476 participants (estimated)
- Lead sponsor
- InnoCare Pharma Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2024 (actual)
- Primary completion
- 25 Jun 2031 (estimated)
- Study completion
- 25 Jun 2032 (estimated)
- First posted
- 12 Apr 2024 (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.
Compare the efficacy and safety of Orelabrutinib plus bendamustine+ rituximab versus bendamustine + rituximab in previously untreated patients with mantle cell lymphoma (MCL)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Active comparator | Drug: Orelabrutinib, Drug: Bendamustine Injection, Drug: Rituximab |
| Arm B | Active comparator | Drug: Bendamustine Injection, Drug: Rituximab, Drug: Orelabrutinib Placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Modified Ann Arbor stage II-IV. Patients with stage II require systemic treatment to be eligible, at the discretion of the investigator.
- 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.
- 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).
- ECOG PS score of 0 to 2.
Key exclusion criteria (5 listed)
- Existing or prior history of other malignant tumor and no evidence of recurrence and metastasis within 2 years before screening.
- Subjects with evident gastrointestinal dysfunction that may affect drug intake, transport or absorption, or subjects who have undergone total gastrectomy.
- Subjects for whom the goal of therapy is tumor debulking prior to stem cell transplant.
- 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.
- Known central nervous system lymphoma.
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 |
|---|---|---|
| OrelabrutinibEligible patients will receive Orelabrutinib orally as per the protocol，until disease progression or other reasons for treatment discontinuation，whichever comes first. | Drug | Arm A |
| Bendamustine InjectionEligible patients will receive Bendamustine by injection as per the protocol | Drug | Arm A, Arm B |
| RituximabEligible patients will receive Rituximab by injection as per the protocol | Drug | Arm A, Arm B |
| Orelabrutinib PlaceboEligible patients will receive Orelabrutinib Placebo orally as per the protocol | Drug | Arm B |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 28 days
Progression-free Survival (PFS) for Arm A vs. Arm B
Time frame: Approximately 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
39 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, Bendamustine Injection and Rituximab in people with Mantle Cell Lymphoma, run by InnoCare Pharma Inc. at 39 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 28 days). The study lists 2 primary outcomes in all. 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 27 Dec 2024.