Mantle Cell Lymphoma (MCL)Phase 3NCT06496308
Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment
A Phase 3 study testing Orelabrutinib, Bendamustine and Rituximab in people with Mantle Cell Lymphoma (MCL), run by Ruijin Hospital at 1 site in China.
Trial summary
This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mantle Cell Lymphoma (MCL)
- What is being tested?
- Orelabrutinib, Bendamustine and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 10 Jul 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
- Age > 18 years of age, both genders are eligible.
- Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.
- At least one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Any one of the following high-risk factors is present: MIPI score of 4-11, Ki67 > 50%, TP53 abnormality, blastic or pleomorphic variation.
Show all 10Show fewer
- Patients who are not suitable candidates for autologous hematopoietic stem cell transplantation.
- Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10^9/L, absolute neutrophil count ≥1.5×10^9/L, hemoglobin ≥90g/L, platelet count ≥75×10^9/L. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol/L.
- The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.
- Willing and able to participate in all required assessments and procedures of the study protocol.
Who cannot join
- Patients who have previously received treatment with BTK inhibitors.
- Patients with severe complications or serious infections.
- Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
- Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
- HIV-infected individuals.
- Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.
- Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, 200025
Weili Zhao, 13512112076, zhao.weili@yahoo.com
About this study
Official title: A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)
This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.
- Conditions
- Mantle Cell Lymphoma (MCL)
- Being tested
- Orelabrutinib, Bendamustine, Rituximab, Venetoclax
- 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
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
BendamustineDrug
Bendamustine IV will be administered as per the schedule specified in the respective arm.
RituximabDrug
Rituximab IV will be administered as per the schedule specified in the respective arm.
VenetoclaxDrug
Venetoclax PO will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| Orelabrutinib + Bendamustine + Rituximab (OBR) | Experimental | In induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in OBR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, and orelabrutinib 150mg/day PO once daily, every 28 day per cycle for 6 cycles. Receives: Drug: Orelabrutinib; Drug: Bendamustine; Drug: Rituximab |
| Bendamustine + Rituximab (BR) | Placebo comparator | In induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in BR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, every 28 day per cycle for 6 cycles. Receives: Drug: Bendamustine; Drug: Rituximab |
| Orelabrutinib + Venetoclax (OV) | Other | In maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients with TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily and venetoclax for up to 2 years, the dosing of Venetoclax is escalated gradually to reach a target dose of 400 mg. Receives: Drug: Orelabrutinib; Drug: Venetoclax |
| Orelabrutinib (O) | Other | In maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients without TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily for up to 2 years. Receives: Drug: Orelabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Secondary outcomes (3)
Overall Response Rate
Percentage of participants with overall response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Progression-free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Overall survival
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start10 Jul 2024 (estimated)
- Primary completion10 Jul 2027 (estimated)
- Study completion10 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Xiangya Hospital of Central South University, Anhui Provincial Cancer Hospital, Fujian Medical University Union Hospital, Yantai Yuhuangding Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Anhui Medical University, Jiangxi Provincial Cancer Hospital, Fujian Cancer Hospital
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496308
- Sponsor's protocol ID
- ORDER
- Status last verified
- Jul 2024
- First submitted
- 3 Jul 2024
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)
- ClinicalTrials.gov ID
- NCT06496308
- Acronym / sponsor ID
- ORDER
- Conditions
- Mantle Cell Lymphoma (MCL)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- The Third Xiangya Hospital of Central South University, Anhui Provincial Cancer Hospital, Fujian Medical University Union Hospital, Yantai Yuhuangding Hospital, Huadong Hospital Affiliated with Fudan University, Shanghai, The First Affiliated Hospital of Anhui Medical University, Jiangxi Provincial Cancer Hospital, Fujian Cancer Hospital
- Study start
- 10 Jul 2024 (estimated)
- Primary completion
- 10 Jul 2027 (estimated)
- Study completion
- 10 Jul 2027 (estimated)
- First posted
- 11 Jul 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.
This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Orelabrutinib + Bendamustine + Rituximab (OBR) | Experimental | Drug: Orelabrutinib, Drug: Bendamustine, Drug: RituximabIn induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in OBR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, and orelabrutinib 150mg/day PO once daily, every 28 day per cycle for 6 cycles. |
| Bendamustine + Rituximab (BR) | Placebo comparator | Drug: Bendamustine, Drug: RituximabIn induction phase, patients will be randomized in two groups, one is OBR and another is BR. Patients in BR group will receive rituximab 375 mg/m² IV on day 1, bendamustine 90 mg/m² IV on day 1 and 2, every 28 day per cycle for 6 cycles. |
| Orelabrutinib + Venetoclax (OV) | Other | Drug: Orelabrutinib, Drug: VenetoclaxIn maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients with TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily and venetoclax for up to 2 years, the dosing of Venetoclax is escalated gradually to reach a target dose of 400 mg. |
| Orelabrutinib (O) | Other | Drug: OrelabrutinibIn maintanance phase, patients will receive different medical regimen according to their TP53 mutation and blastic and pleomorphic variants status. Patients without TP53 mutation or blastic and/or pleomorphic variant will receive orelabrutinib 150mg/day PO once daily for up to 2 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.
- Age > 18 years of age, both genders are eligible.
- Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.
- At least one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Key exclusion criteria (7 listed)
- Patients who have previously received treatment with BTK inhibitors.
- Patients with severe complications or serious infections.
- Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.
- Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.
- HIV-infected individuals.
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 PO will be administered as per the schedule specified in the respective arm. | Drug | Orelabrutinib (O), Orelabrutinib + Bendamustine + Rituximab (OBR), Orelabrutinib + Venetoclax (OV) |
| BendamustineBendamustine IV will be administered as per the schedule specified in the respective arm. | Drug | Bendamustine + Rituximab (BR), Orelabrutinib + Bendamustine + Rituximab (OBR) |
| RituximabRituximab IV will be administered as per the schedule specified in the respective arm. | Drug | Bendamustine + Rituximab (BR), Orelabrutinib + Bendamustine + Rituximab (OBR) |
| VenetoclaxVenetoclax PO will be administered as per the schedule specified in the respective arm. | Drug | Orelabrutinib + Venetoclax (OV) |
Primary outcome
Complete response rate
Time frame: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
3 secondary outcomes
Overall Response Rate
Time frame: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Progression-free survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Overall survival
Time frame: Baseline up to data cut-off (up to approximately 2 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 11 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Mantle Cell Lymphoma (MCL)
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Not yet recruitingPhase 2
A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma
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.
1 site 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 and Rituximab in people with Mantle Cell Lymphoma (MCL), run by Ruijin Hospital at 1 site 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 10 inclusion and 7 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 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 Weili Zhao (+862164370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: End of induction treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]). 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 Jul 2024.