Relapsed/Refractory Marginal Zone LymphomaPhase 3NCT06082102
Efficacy and Safety of Orelabrutinib Combined With Rituximab Versus Lenalidomide Combined With Rituximab in Patients With Relapsed/Refractory Marginal Zone Lymphoma
A Phase 3 study testing Orelabrutinib, Rituximab and Lenalidomide in people with Relapsed/Refractory Marginal Zone Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 19 sites in China.
Trial summary
Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed/Refractory Marginal Zone Lymphoma
- What is being tested?
- Orelabrutinib, Rituximab and Lenalidomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 19 sitesChina
- Study dates
- 19 Dec 2023to 25 Feb 2030
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years , either sex.
- Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
- Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:
- For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements
- Relapsed or refractory disease.
- At least 1 measurable lesion confirmed through enhanced computed tomography (CT) or enhanced magnetic resonance imaging (MRI).
- ECOG performance status (PS) score of 0-2.
Who cannot join
- Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
- Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up).
- Prior treatment with any types of BTK inhibitor.
- Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose.
- Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites, 19 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Lin Fu
- Recruiting
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Liang Wang
- Recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Auhui, 233000
Yanli Yang
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Yajun Li
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Liqun Zou
- Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning, 116023
Xiaojing Yan
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510055
Huiqiang Huang
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Xiping Dai
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Wenjuan Yu
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fei Li
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Wuping Li
- Not yet recruiting
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, 266000
Xia Zhao
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200040
Yan Yuan
- Recruiting
The first Hospital of China Medical University
Shenyang, Liaoning, 110002
Xiaojing Yan
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Yu Hu
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）
Xi’an, Shanxi, 710004
Wanhong Zhao
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264099
Xiaoxia Chu
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Keshu Zhou
- Recruiting
Henan Provincial Peoples Hospital
Zhengzhou, Henan, 450003
Zunmin Zhu
About this study
Official title: A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma
Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma
- Being tested
- Orelabrutinib, Rituximab, Lenalidomide
- Medical subject headings
- Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrelabrutinibDrug
Orelabrutinib Tablets
RituximabDrug
Rituximab Injection
LenalidomideDrug
Lenalidomide Capsules
RituximabDrug
Rituximab Injection
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib | Experimental | Not described Receives: Drug: Orelabrutinib; Drug: Rituximab |
| Comparator | Active comparator | Not described Receives: Drug: Lenalidomide; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
IRC-assessed PFS
Measured: Through study completion, an average of 5 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start19 Dec 2023
- Primary completion31 Aug 2028 (estimated)
- Study completion25 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Marginal Zone LymphomaStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- 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
- 324 participants (estimated)
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
- NCT06082102
- Sponsor's protocol ID
- ICP-CL-00123
- Status last verified
- Sep 2025
- First submitted
- 8 Oct 2023
- Last updated
- 15 Sep 2025
- 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 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Open-label, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Orelabrutinib Plus Rituximab Versus Lenalidomide Plus Rituximab in Relapsed/Refractory Marginal Zone Lymphoma
- ClinicalTrials.gov ID
- NCT06082102
- Acronym / sponsor ID
- ICP-CL-00123
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 25 Feb 2030 (estimated)
- First posted
- 13 Oct 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.
Efficacy and Safety of Orelabrutinib Combined with Rituximab versus Lenalidomide Combined with Rituximab in Patients with Relapsed/Refractory Marginal Zone Lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib | Experimental | Drug: Orelabrutinib, Drug: Rituximab |
| Comparator | Active comparator | Drug: Lenalidomide, Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years , either sex.
- Histopathologically confirmed B-cell non-Hodgkin lymphoma MZL (splenic, nodal, or extra-nodal).
- Prior systemic therapy including at least one anti-CD20 monoclonal antibody-containing regimen is required, with the following specifications:
- For combination therapies: Minimum of 2 completed treatment cycles For anti-CD20 monotherapy: Minimum of 4 administered doses Progression during treatment waives cycle/dose requirements
- Relapsed or refractory disease.
Key exclusion criteria (5 listed)
- Administration of the specified anti-tumor therapies within 2 weeks prior to the first dose of the study treatment.
- Administration of any other investigational product within 4 weeks prior to the first dose of the study treatment, or concurrent participation in another clinical trial.(Excluding patients who have discontinued treatment and are in long-term follow-up).
- Prior treatment with any types of BTK inhibitor.
- Patients refractory to lenalidomide plus rituximab (R2 regimen). Refractoriness is defined as either: Failure to achieve at least partial response (PR) after completing an adequate R2 treatment course (≥2 cycles at standard doses), OR Disease progression during R2 therapy or within 6 months after the last dose.
- Central nervous system (CNS) lymphoma, and lymphoma with CNS or meningeal involvements.
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 |
|---|---|---|
| OrelabrutinibOrelabrutinib Tablets | Drug | Orelabrutinib |
| RituximabRituximab Injection | Drug | Orelabrutinib |
| LenalidomideLenalidomide Capsules | Drug | Comparator |
| RituximabRituximab Injection | Drug | Comparator |
Primary outcome
IRC-assessed PFS
Time frame: Through study completion, an average of 5 year.
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 15 Sep 2025.
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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.
19 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, Rituximab and Lenalidomide in people with Relapsed/Refractory Marginal Zone Lymphoma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 19 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 7 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
IRC-assessed PFS (time frame: Through study completion, an average of 5 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 15 Sep 2025.