Mantle Cell LymphomaPhase 2ZGRNCT06504199
Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma
A Phase 2 study testing Obinutuzumab, Zanubrutinib and Lenalidomide in people with Mantle Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 2 sites in China.
Trial summary
This study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide (ZGR) followed by a short cycle of cytarabine and Obinutuzumab in the induction treatment of newly diagnosed mantle cell lymphoma (MCL) . Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- Obinutuzumab, Zanubrutinib 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
- 39 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jul 2024to 31 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years, male or female;
- Patients with pathologically (histologically or cytologically) confirmed MCL and at least one measurable lesion by Lugano criteria;
- No prior systemic therapy for MCL;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2 points;
- Normal function of vital organs, i.e. meeting the following criteria:
- Blood routine examination must be in accordance with (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days): i. Absolute neutrophil count (ANC) ≥ 1 × 10＾9/L; ii. Platelet count (PLT) ≥ 75 × 10＾9/L; b) Chemistry panel must meet the following criteria: i. Total bilirubin (TBIL) ≤ 2.0 × upper limit of normal (ULN); ii. Glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST) ≤ 2.0 × ULN iii. Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula); c) Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;
- Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the start of study medication and are willing to use a medically recognized highly effective contraceptive method (e.g., intrauterine device, contraceptive pill, or condom) during the study and within 6 months after the last dose of study drug; male subjects with partners of childbearing potential should be surgically sterile or agree to use an effective method of contraception during the study and within 6 months after the last dose of study drug;
- The subjects voluntarily participate in the study and sign the informed consent form. They have good compliance and cooperate in the follow-up.
Who cannot join
- Known central nervous system disease such as brain or meninges, including central nervous system lymphoma.
- Congestive heart failure, Class III or IV (New York Heart Association, NYHA);
- Other primary malignancies within the last 3 years (except non-melanoma skin cancer, curatively treated localized prostate cancer, carcinoma in situ of the cervix, or squamous epithelial endothelial lesions on PAP smear)
- Previous use of investigational drugs;
- Any active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug;
- Use of immunosuppressive agents, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 20 mg/day prednisone or its equivalent) within 7 days prior to the first dose of study drug
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- Allergic reactions, anaphylactic reactions and adverse drug reactions
- Severe allergic reactions to other monoclonal antibodies;
- Allergy or intolerance to infusion;
- Patients with a history of serious allergy to the investigational drug or its preventive medication;
- Physical examination and laboratory findings
- Patients with congenital or acquired immunodeficiency, such as active hepatitis B virus (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of detection of the analytical method) or combined hepatitis B and C co-infection;
- Pregnant or lactating women; patients with fertility are unwilling or unable to take effective contraceptive measures;
- Known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);
- Any condition that, in the opinion of the investigator, may jeopardize the subject or may render the subject unable to meet or perform the study requirements;
- Other conditions that the investigator considers inappropriate for entry into this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
About this study
Official title: A Prospective, Open-Label, Single-Arm Study of Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle Cytarabine in First-Line Treatment of Mantle Cell Lymphoma
This study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide (ZGR) followed by a short cycle of cytarabine and Obinutuzumab in the induction treatment of newly diagnosed mantle cell lymphoma (MCL) . The investigators propose ZGR followed by a short cycle of Obinutuzumab and cytarabine could be an effective first-line treatment for MCL.
Read the detailed description
Based on the clinical need for first-line treatment of MCL, this study proposed to enroll 39 patients with MCL who have not previously received any systemic therapy for MCL. All patients were treated with ZGR regimen for 6 cycles after enrollment, followed by 3 cycles of Obinutuzumab + cytarabine in 28-day cycles. For non-high-risk patients, lenalidomide and Zanubrutinib were used for maintenance; high-risk patients continued Lenalidomide and Zanubrutinib for maintenance following CAR-T cell therapy for 1 year for Lenalidomide and 2 years for Zanubrutinib. The primary endpoint of CRR and secondary endpoints (including ORR, PFS, DoR, and OS) were followed and recorded to explore the efficacy and safety of ZGR followed by a short cycle of Obinutuzumab and cytarabine induction therapy in treatment-naive MCL.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- Obinutuzumab, Zanubrutinib, Lenalidomide, Cytarabine, CAR-T
- Keywords
- newly diagnosed, Mantle Cell Lymphoma, ZGR, Short-Cycle Cytarabine
- 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.
ObinutuzumabDrug
No dose adjustment of Obinutuzumab is allowed.
ZanubrutinibDrug
Zanubrutinib was allowed to be titrated to 80 mg bid or 80 mg qd
LenalidomideDrug
Lenalidomide was allowed to be titrated to 15 mg/day (induction phase) or 5 mg/day (maintenance phase).
CytarabineDrug
The specific dose is determined by the investigator according to the actual situation of the patient.
CAR-TBiological
zanubrutinib in combination with lenalidomide was allowed for maintenance treatment in high-risk patients for 1 year and zanubrutinib for 2 years after recovery of hemogram 2 months after CAR-T. High-risk Patients with any of the following conditions: Mantle cell lymphoma International Prognostic Index (MIPI-c) high-risk, blastic/pleomorphic type, TP53 mutation/deletion, CDKN2A deletion, MYC amplification/translocation, or incomplete response at induction stage; Non-high-risk group: no high-risk features.
| Study group | Role | What they receive |
|---|---|---|
| ZGR followed short cycle of Obinutuzumab and Cytarabine | Experimental | All patients were treated with ZGR regimen for 6 cycles after enrollment, followed by 3 cycles of Obinutuzumab and Cytarabine in 28-day cycles. Obinutuzumab: 1000 mg, intravenous drip, administered on d1, d8 and d15 of the first cycle, and administered on the first day of each cycle starting from the second cycle. Zanubrutinib: 160 mg, bid, continuous oral. Lenalidomide: 20 mg/d, qd, oral, d1-d21.Cytarabine: for young tolerable patients, the dose is 2 g/m2, q12h, intravenous drip, d1-2ND for elderly/intolerant patients, the dose is 500 mg/m2, q12h, intravenous drip, completed 2-3 hours, d1-3. The specific dose is determined by the investigator according to the actual situation of the patient. Zanubrutinib for 2 years combination with Lenalidomide for 1 year was used for maintenance treatment in non-high-risk patients and in high-risk patients after recovery of hemogram 2 months after CAR-T. Receives: Drug: Obinutuzumab; Drug: Zanubrutinib; Drug: Lenalidomide; Drug: Cytarabine; Biological: CAR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate (CRR)
defined as the proportion of patients with complete response as assessed by response to induction therapy using the 2014 Lugano criteria.
Measured: up to the end of 9 cycles of treatment(each cycle is 28 days)
Secondary outcomes (5)
overall response rate (ORR)
defined as the proportion of patients with complete or partial response as assessed by response to induction therapy.
Measured: up to the end of 9 cycles of treatment(each cycle is 28 days)
Minimal residual disease (MRD) negative rate of
defined as the proportion of patients with MRD negative (less than 10-4) in bone marrow by flow cytometry after induction therapy in newly diagnosed patients with bone marrow invasion.
Measured: up to the end of 9 cycles of treatment(each cycle is 28 days)
Progress-free survival (PFS)
defined as the time from the start of treatment to disease progression or death due to any cause.
Measured: up to 5 years
Duration of tumor remission (DoR)
defined as the time from the first treatment response (including complete response and partial response) to the last assessment of response.
Measured: up to 5 years
Overall survival (OS)
defined as the time from enrollment to death for any cause.
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start18 Jul 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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 Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Model description
- reated with 6 cycles of ZGR followed by a short cycle (3 cycles) of cytarabine + Obinutuzumab induction therapy. The maintenance regimen was selected according to patient risk stratification. Zanubrutinib in combination with lenalidomide was used for maintenance treatment in non-high-risk patients; maintenance treatment with zanubrutinib in combination with lenalidomide was allowed in high-risk patients after recovery of hemogram 2 months after treatment with chimeric antigen receptor T cells (CAR-T), with lenalidomide maintained for 1 year and zanubrutinib maintained for 2 years.
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhua Yi, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504199
- Sponsor's protocol ID
- IIT2024010
- Acronym
- ZGR
- Status last verified
- May 2026
- First submitted
- 10 Jul 2024
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm Study of Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle Cytarabine in First-Line Treatment of Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT06504199
- Acronym / sponsor ID
- ZGR / IIT2024010
- Conditions
- Mantle Cell Lymphoma
- Keywords
- newly diagnosed, Mantle Cell Lymphoma, ZGR, Short-Cycle Cytarabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 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 study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide (ZGR) followed by a short cycle of cytarabine and Obinutuzumab in the induction treatment of newly diagnosed mantle cell lymphoma (MCL) . The investigators propose ZGR followed by a short cycle of Obinutuzumab and cytarabine could be an effective first-line treatment for MCL.
Detailed description
Based on the clinical need for first-line treatment of MCL, this study proposed to enroll 39 patients with MCL who have not previously received any systemic therapy for MCL. All patients were treated with ZGR regimen for 6 cycles after enrollment, followed by 3 cycles of Obinutuzumab + cytarabine in 28-day cycles. For non-high-risk patients, lenalidomide and Zanubrutinib were used for maintenance; high-risk patients continued Lenalidomide and Zanubrutinib for maintenance following CAR-T cell therapy for 1 year for Lenalidomide and 2 years for Zanubrutinib. The primary endpoint of CRR and secondary endpoints (including ORR, PFS, DoR, and OS) were followed and recorded to explore the efficacy and safety of ZGR followed by a short cycle of Obinutuzumab and cytarabine induction therapy in treatment-naive MCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- reated with 6 cycles of ZGR followed by a short cycle (3 cycles) of cytarabine + Obinutuzumab induction therapy. The maintenance regimen was selected according to patient risk stratification. Zanubrutinib in combination with lenalidomide was used for maintenance treatment in non-high-risk patients; maintenance treatment with zanubrutinib in combination with lenalidomide was allowed in high-risk patients after recovery of hemogram 2 months after treatment with chimeric antigen receptor T cells (CAR-T), with lenalidomide maintained for 1 year and zanubrutinib maintained for 2 years.
| Arm | Type | Receives |
|---|---|---|
| ZGR followed short cycle of Obinutuzumab and Cytarabine | Experimental | Drug: Obinutuzumab, Drug: Zanubrutinib, Drug: Lenalidomide, Drug: Cytarabine, Biological: CAR-TAll patients were treated with ZGR regimen for 6 cycles after enrollment, followed by 3 cycles of Obinutuzumab and Cytarabine in 28-day cycles. Obinutuzumab: 1000 mg, intravenous drip, administered on d1, d8 and d15 of the first cycle, and administered on the first day of each cycle starting from the second cycle. Zanubrutinib: 160 mg, bid, continuous oral. Lenalidomide: 20 mg/d, qd, oral, d1-d21.Cytarabine: for young tolerable patients, the dose is 2 g/m2, q12h, intravenous drip, d1-2ND for elderly/intolerant patients, the dose is 500 mg/m2, q12h, intravenous drip, completed 2-3 hours, d1-3. The specific dose is determined by the investigator according to the actual situation of the patient. Zanubrutinib for 2 years combination with Lenalidomide for 1 year was used for maintenance treatment in non-high-risk patients and in high-risk patients after recovery of hemogram 2 months after CAR-T. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged 18 to 80 years, male or female;
- Patients with pathologically (histologically or cytologically) confirmed MCL and at least one measurable lesion by Lugano criteria;
- No prior systemic therapy for MCL;
- Eastern Cooperative Oncology Group (ECOG) score of 0-2 points;
- Normal function of vital organs, i.e. meeting the following criteria:
Key exclusion criteria (16 listed)
- Known central nervous system disease such as brain or meninges, including central nervous system lymphoma.
- Congestive heart failure, Class III or IV (New York Heart Association, NYHA);
- Other primary malignancies within the last 3 years (except non-melanoma skin cancer, curatively treated localized prostate cancer, carcinoma in situ of the cervix, or squamous epithelial endothelial lesions on PAP smear)
- Previous use of investigational drugs;
- Any active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug;
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 |
|---|---|---|
| ObinutuzumabNo dose adjustment of Obinutuzumab is allowed. | Drug | ZGR followed short cycle of Obinutuzumab and Cytarabine |
| ZanubrutinibZanubrutinib was allowed to be titrated to 80 mg bid or 80 mg qd | Drug | ZGR followed short cycle of Obinutuzumab and Cytarabine |
| LenalidomideLenalidomide was allowed to be titrated to 15 mg/day (induction phase) or 5 mg/day (maintenance phase). | Drug | ZGR followed short cycle of Obinutuzumab and Cytarabine |
| CytarabineThe specific dose is determined by the investigator according to the actual situation of the patient. | Drug | ZGR followed short cycle of Obinutuzumab and Cytarabine |
| CAR-Tzanubrutinib in combination with lenalidomide was allowed for maintenance treatment in high-risk patients for 1 year and zanubrutinib for 2 years after recovery of hemogram 2 months after CAR-T. High-risk Patients with any of the following conditions: Mantle cell lymphoma International Prognostic Index (MIPI-c) high-risk, blastic/pleomorphic type, TP53 mutation/deletion, CDKN2A deletion, MYC amplification/translocation, or incomplete response at induction stage; Non-high-risk group: no high-risk features. | Biological | ZGR followed short cycle of Obinutuzumab and Cytarabine |
Primary outcome
Complete response rate (CRR)
Time frame: up to the end of 9 cycles of treatment(each cycle is 28 days)
defined as the proportion of patients with complete response as assessed by response to induction therapy using the 2014 Lugano criteria.
5 secondary outcomes
overall response rate (ORR)
Time frame: up to the end of 9 cycles of treatment(each cycle is 28 days)
Minimal residual disease (MRD) negative rate of
Time frame: up to the end of 9 cycles of treatment(each cycle is 28 days)
Progress-free survival (PFS)
Time frame: up to 5 years
Duration of tumor remission (DoR)
Time frame: up to 5 years
Overall survival (OS)
Time frame: up to 5 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 13 May 2026.
- 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. This study is not recruiting at the moment.
Shuhua Yi principal investigator
Institute of Hematology & Blood Diseases Hospital, China
2 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 Obinutuzumab, Zanubrutinib and Lenalidomide in people with Mantle Cell Lymphoma, run by Institute of Hematology & Blood Diseases Hospital, China at 2 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 8 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Complete response rate (CRR) (time frame: up to the end of 9 cycles of treatment(each cycle is 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 13 May 2026.