Mantle Cell LymphomaPhase 2ADAPT-MCLNCT07206264
Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment
A Phase 2 study testing Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody in people with Mantle Cell Lymphoma, run by Tianjin Medical University Cancer Institute and Hospital at 5 sites in China.
Trial summary
This is a single-arm, multi-center, prospective, phase II study. The primary objective is to assess the efficacy and safety of bendamustine/orelabrutinib combined with an anti-CD20 monoclonal antibody in treatment-naïve patients with mantle cell lymphoma. 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?
- Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 5 sitesChina
- Study dates
- Oct 2025to Dec 2028
- Phase
- Phase 2
- 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
- Gender not limited, aged ≥65 years, or aged ≥60 years but <65 years and unsuitable or unwilling to undergo stem cell transplantation due to the following reasons:
- Creatinine clearance rate >30 mL/min, but <70 mL/min;
- Presence of other comorbidities that contraindicate high-intensity induction chemotherapy;
- High-risk patients who are expected to fail stem cell mobilization and collection (such as those with bone marrow infiltration, diabetes, thrombocytopenia). Patients who are unwilling to receive autologous stem cell transplantation, considering potential complications post-transplantation (such as prolonged bleeding, immunodeficiency, hemorrhage, severe infections), and relapse.
- Histologically confirmed mantle cell lymphoma at stages II-IV;
- Patients who have not received prior treatment;
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Adequate organ function:
- Hematological: Absolute neutrophil count ≥1.5×109/L, platelets ≥75×109/L, hemoglobin ≥75 g/L. If accompanied by bone marrow involvement: Absolute neutrophil count ≥1.0×109/L, platelets ≥50×109/L, hemoglobin ≥50 g/L.
- Biochemical: Total bilirubin ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) or alanine transaminase (ALT) ≤2 times ULN.
- Coagulation function: International normalized ratio (INR) ≤1.5 times ULN;
- Expected survival time ≥12 months;
- Voluntarily sign a written informed consent form before the trial screening.
Who cannot join
- Progression to higher-grade disease or central nervous system involvement;
- Uncontrolled or significant cardiovascular diseases:
- Within 6 months prior to the first administration of the study drug, there was New York Heart Association (NYHA) class II or higher congestive heart failure, unstable angina pectoris, myocardial infarction, or a need for treatment of arrhythmia at the time of screening, with left ventricular ejection fraction (LVEF) < 50%;
- Primary cardiomyopathies (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, and unclassified cardiomyopathy);
- A history of clinically significant QTc interval prolongation, or a QTc interval >470 ms for females or >450 ms for males during the screening period;
- Participants with symptomatic or medication-requiring coronary artery disease;
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- Participants with uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite adequate therapy with three antihypertensive agents (including a diuretic) for at least one month, or requiring four or more antihypertensive agents to achieve control.
- Participants with active bleeding within 2 months prior to screening, those currently on anticoagulant therapy, or those deemed by the investigator to have a significant risk of bleeding;
- History of deep vein thrombosis or pulmonary embolism within the past 6 months;
- Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery is defined as any surgical procedure requiring general anesthesia; diagnostic endoscopy is not considered major surgery;
- Active infection or uncontrolled hepatitis B virus (HBV) infection (HBsAg positive and/or HBcAb positive with detectable HBV DNA), hepatitis C virus (HCV) antibody positive, HIV/AIDS, or other severe infectious diseases;
- Participants with pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation-induced lung disease, drug-related lung disease, or other conditions affecting pulmonary function;
- Pregnant women, breastfeeding women, and fertile participants unwilling to use effective contraception;
- Participants requiring continuous use of drugs with strong inhibition or induction effects on cytochrome P450 CYP3A4;
- Other conditions deemed unsuitable for participation in this trial by the investigator.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
Fujian Provincial Cancer Hospital
Fuzhou, Fujian
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Shandong Cancer Hospital
Jinan, Shandong
Hebei Medical University Tumor Hospital
Shijiazhuang, Hebei
Tianjin Medical University Cancer Institute and Hospital
Tianjin
About this study
Official title: Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment: a Multi-center, Phase II Study
This is a single-arm, multi-center, prospective, phase II study. The primary objective is to assess the efficacy and safety of bendamustine/orelabrutinib combined with an anti-CD20 monoclonal antibody in treatment-naïve patients with mantle cell lymphoma.
Read the detailed description
Mantle cell lymphoma (MCL) is a subtype of B-cell non-Hodgkin's lymphoma and is considered to be incurable. MCL patients have varied clinical presentations (generally symptomatic to an asymptomatic indolent clinical course). Over the past decade, significant advances in the treatment of MCL have been achieved through intensive immunochemotherapy regimens and clinical trials evaluating novel targeted agents and combination strategies. However, early disease relapse remains a frequent clinical challenge. Recently, combination regimens involving chemotherapy and targeted therapy have demonstrated promising efficacy with acceptable safety profiles. Bendamustine is a unique cytotoxic agent that induces apoptosis through activation of DNA damage stress responses, disruption of mitotic checkpoints, and induction of mitotic catastrophe. Zuberitamab is a novel anti-CD20 monoclonal antibody that demonstrates enhanced antibody-dependent cellular cytotoxicity compared with rituximab. Orelabrutinib is a potent, irreversible, and highly selective Bruton tyrosine kinase inhibitor.
This study is a multicenter, prospective trial involving previously untreated patients with MCL. During the induction phase (cycles 1-4), all patients will receive bendamustine at a dose of 90 mg/m² in combination with anti-CD20 monoclonal antibody at 375 mg/m². After cycle 4, patients who achieve a complete response (CR) and are minimal residual disease (MRD) negative will continue to receive the same regimen (bendamustine 90 mg/m² plus anti-CD20 monoclonal antibody 375mg/m²) for cycles 5 to 6. In contrast, patients who are MRD positive will switch to a treatment regimen consisting of orelabrutinib at 150 mg combined with anti-CD20 monoclonal antibody at 375 mg/m². During the maintenance phase (cycles 7-24), patients who achieve CR and are MRD negative at cycle 4 will continue receiving bendamustine plus anti-CD20 monoclonal antibody, while MRD-positive patients will continue treatment with orelabrutinib plus anti-CD20 monoclonal antibody until disease progression, relapse, intolerable toxicities, death, loss to follow-up, or withdrawal of consent, whichever occurs first, with a maximum of 24 cycles.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody
- Keywords
- Lymphoma, Mantle cell lymphoma, Bendamustine, anti-CD20 monoclonal antibody, Orelabrutinib
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibodyDrug
Also called BR/OR
Induction phase (cycle 1-6):
Bendamustine (90 mg/m², day 1-2) +anti-CD20 monoclonal antibody (375 mg/m², day 0) from cycles 1-4. Patients who achieve CR and MRD negative continue to receive bendamustine (90 mg/m², day 1-2) + anti-CD20 monoclonal antibody (375 mg/m², day 0) from cycles 5-6; MRD positive patients receive orelabrutinib (150 mg) + anti-CD20 monoclonal antibody (375 mg/m², day 0).
Maintenance phase (cycle 7-24):
Patients who achieve CR and are MRD negative at cycle 4 receive bendamustine (90 mg/m², day 1-2) + anti-CD20 monoclonal antibody (375 mg/m², day 0); MRD-positive patients receive orelabrutinib (150 mg) + anti-CD20 monoclonal antibody (375 mg/m², day 0).
| Study group | Role | What they receive |
|---|---|---|
| Mantle cell lymphoma: bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclo | Experimental | Drug: bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody Receives: Drug: Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS is defined as the time from the initiation of treatment to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. Patients who remain alive and progression-free at the data cutoff date, PFS will be censored at the last tumor assessment date.
Measured: From the date of the initiation of treatment until the date of first documented progression, up to 2 years.
Secondary outcomes (6)
Overall response rate (ORR)
The ORR is defined as the proportion of patients with a response of CR or PR.
Measured: From the initiation of treatment to the end of therapy, up to 2 years.
Complete response rate (CRR)
Complete response rate is defined as the proportion of patients with a response of CR.
Measured: From the initiation of treatment to the end of therapy, up to 2 years.
Duration of Response (DOR)
DOR is defined as the time from documentation of response to treatment to the first documentation of tumor progression or death due to any cause, whichever comes first.
Measured: From the first demonstration of response until disease progression/death, up to 2 years.
Time to response (TTR)
TTR is defined as the time from the start of therapy to the first response.
Measured: From the start of therapy to the first documentation of response.
Overall survival (OS)
OS is defined as the time from the initiation of treatment to death from any cause. Patients alive at the data cutoff date will have their OS censored at the date of the last follow-up.
Measured: From the date of the initiation of treatment until the date of death, up to 3 years.
Adverse events (AEs)
AEs will be graded according to the NCI-CTCAE Version 5.0.
Measured: From the date of enrollment until the date of death, up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (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.
- More trials run by Tianjin Medical University Cancer Institute and 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huilai Zhang, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206264
- Sponsor's protocol ID
- ADAPT-MCL
- Acronym
- ADAPT-MCL
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- 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 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemotherapy Combined With Targeted Therapy as First-line Treatment for Mantle Cell Lymphoma Based on MRD and PET-CT Assessment: a Multi-center, Phase II Study
- ClinicalTrials.gov ID
- NCT07206264
- Acronym / sponsor ID
- ADAPT-MCL / ADAPT-MCL
- Conditions
- Mantle Cell Lymphoma
- Keywords
- Lymphoma, Mantle cell lymphoma, Bendamustine, anti-CD20 monoclonal antibody, Orelabrutinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Oct 2025 (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 single-arm, multi-center, prospective, phase II study. The primary objective is to assess the efficacy and safety of bendamustine/orelabrutinib combined with an anti-CD20 monoclonal antibody in treatment-naïve patients with mantle cell lymphoma.
Detailed description
Mantle cell lymphoma (MCL) is a subtype of B-cell non-Hodgkin's lymphoma and is considered to be incurable. MCL patients have varied clinical presentations (generally symptomatic to an asymptomatic indolent clinical course). Over the past decade, significant advances in the treatment of MCL have been achieved through intensive immunochemotherapy regimens and clinical trials evaluating novel targeted agents and combination strategies. However, early disease relapse remains a frequent clinical challenge. Recently, combination regimens involving chemotherapy and targeted therapy have demonstrated promising efficacy with acceptable safety profiles. Bendamustine is a unique cytotoxic agent that induces apoptosis through activation of DNA damage stress responses, disruption of mitotic checkpoints, and induction of mitotic catastrophe. Zuberitamab is a novel anti-CD20 monoclonal antibody that demonstrates enhanced antibody-dependent cellular cytotoxicity compared with rituximab. Orelabrutinib is a potent, irreversible, and highly selective Bruton tyrosine kinase inhibitor.
This study is a multicenter, prospective trial involving previously untreated patients with MCL. During the induction phase (cycles 1-4), all patients will receive bendamustine at a dose of 90 mg/m² in combination with anti-CD20 monoclonal antibody at 375 mg/m². After cycle 4, patients who achieve a complete response (CR) and are minimal residual disease (MRD) negative will continue to receive the same regimen (bendamustine 90 mg/m² plus anti-CD20 monoclonal antibody 375mg/m²) for cycles 5 to 6. In contrast, patients who are MRD positive will switch to a treatment regimen consisting of orelabrutinib at 150 mg combined with anti-CD20 monoclonal antibody at 375 mg/m². During the maintenance phase (cycles 7-24), patients who achieve CR and are MRD negative at cycle 4 will continue receiving bendamustine plus anti-CD20 monoclonal antibody, while MRD-positive patients will continue treatment with orelabrutinib plus anti-CD20 monoclonal antibody until disease progression, relapse, intolerable toxicities, death, loss to follow-up, or withdrawal of consent, whichever occurs first, with a maximum of 24 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mantle cell lymphoma: bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclo | Experimental | Drug: Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibodyDrug: bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Gender not limited, aged ≥65 years, or aged ≥60 years but <65 years and unsuitable or unwilling to undergo stem cell transplantation due to the following reasons:
- Histologically confirmed mantle cell lymphoma at stages II-IV;
- Patients who have not received prior treatment;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Adequate organ function:
Key exclusion criteria (15 listed)
- Progression to higher-grade disease or central nervous system involvement;
- Uncontrolled or significant cardiovascular diseases:
- Participants with active bleeding within 2 months prior to screening, those currently on anticoagulant therapy, or those deemed by the investigator to have a significant risk of bleeding;
- History of deep vein thrombosis or pulmonary embolism within the past 6 months;
- Major surgery within 6 weeks prior to screening or minor surgery within 2 weeks prior to screening. Major surgery is defined as any surgical procedure requiring general anesthesia; diagnostic endoscopy is not considered major surgery;
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 |
|---|---|---|
| Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibodyAlso: BR/ORInduction phase (cycle 1-6): Bendamustine (90 mg/m², day 1-2) +anti-CD20 monoclonal antibody (375 mg/m², day 0) from cycles 1-4. Patients who achieve CR and MRD negative continue to receive bendamustine (90 mg/m², day 1-2) + anti-CD20 monoclonal antibody (375 mg/m², day 0) from cycles 5-6; MRD positive patients receive orelabrutinib (150 mg) + anti-CD20 monoclonal antibody (375 mg/m², day 0). Maintenance phase (cycle 7-24): Patients who achieve CR and are MRD negative at cycle 4 receive bendamustine (90 mg/m², day 1-2) + anti-CD20 monoclonal antibody (375 mg/m², day 0); MRD-positive patients receive orelabrutinib (150 mg) + anti-CD20 monoclonal antibody (375 mg/m², day 0). | Drug | Mantle cell lymphoma: bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclo |
Primary outcome
Progression-free survival (PFS)
Time frame: From the date of the initiation of treatment until the date of first documented progression, up to 2 years.
PFS is defined as the time from the initiation of treatment to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. Patients who remain alive and progression-free at the data cutoff date, PFS will be censored at the last tumor assessment date.
6 secondary outcomes
Overall response rate (ORR)
Time frame: From the initiation of treatment to the end of therapy, up to 2 years.
Complete response rate (CRR)
Time frame: From the initiation of treatment to the end of therapy, up to 2 years.
Duration of Response (DOR)
Time frame: From the first demonstration of response until disease progression/death, up to 2 years.
Time to response (TTR)
Time frame: From the start of therapy to the first documentation of response.
Overall survival (OS)
Time frame: From the date of the initiation of treatment until the date of death, up to 3 years.
Adverse events (AEs)
Time frame: From the date of enrollment until the date of death, up to 3 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 3 Oct 2025.
- 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.
5 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 Bendamustine + anti-CD20 monoclonal antibody/orelabrutinib + anti-CD20 monoclonal antibody in people with Mantle Cell Lymphoma, run by Tianjin Medical University Cancer Institute and Hospital at 5 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 13 inclusion and 15 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: opening soon, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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 Huilai Zhang (18622221228, zhlwgq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From the date of the initiation of treatment until the date of first documented progression, up to 2 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 3 Oct 2025.