Follicular LymphomasPhase 2NCT07505849
ZR2 Versus R2 Regimen in the Treatment of Newly Diagnosed Follicular Lymphoma
A Phase 2 study testing Zanubrutinib+R2 and R2 in people with Follicular Lymphomas, run by KeshuZhou.
Trial summary
Primary Objective: To compare the complete response rate (CR rate) after induction treatment between the ZR2 regimen and the R2 regimen.<br/><br/>Secondary Objectives: To compare the objective response rate (ORR) after induction treatment, progression-free survival (PFS), progression of disease within 24 months… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Follicular Lymphomas
- What is being tested?
- Zanubrutinib+R2 and R2
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 23 Mar 2026to 23 Mar 2030
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily participate in the clinical study; fully understand and comprehend this study and sign the Informed Consent Form (ICF); willing to follow and capable of completing all study steps;
- According to the 5th edition of the WHO classification of hematological and lymphoid tumors, diagnosed as CD20+ classic FL (grade 1-3a FL) by histology, and no previous anti-FL treatment has been received;
- Age ≥ 18 years;
- Judged by the investigator, the subject must urgently need to receive systemic treatment, based on meeting at least one GELF criterion;
- At least one measurable lesion [longest diameter (LDi) ≥ 15mm, lymph node lesion LDi ≥ 10mm, evaluated according to the 2014 Lugano efficacy criteria];
- The subject has at least one measurable target lesion:
Show all 11Show fewer
- PET/CT scan shows positive PET lesion, or ii. CT scan or MRI shows > 1 measurable lymph node lesion (long axis > 1.5 cm) or > 1 measurable extranodal lesion (long axis > 1.0 cm);
- ECOG performance status is 0-2;
- Expected survival period > 3 months;
- Adequate organ function and bone marrow function, without severe heart, lung, liver, kidney and immune deficiencies (no blood transfusion, granulocyte colony-stimulating factor or other medical support drugs within 7 days before starting this study): hemoglobin (HB) ≥ 60 g/L; absolute neutrophil count (ANC) ≥ 5×109/L; platelets (PLT) ≥ 50×109/L; aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 5×ULN; total bilirubin (TBIL) ≤ 1.5×ULN; creatinine clearance rate (Ccr) ≥ 40 ml/min (estimated by Cockcroft-Gault formula); left ventricular ejection fraction (LVEF) ≥ lower limit of normal value.
- Patients with reproductive potential must agree to use effective contraceptive measures (dual methods, such as condom + oral contraceptive), and avoid pregnancy or make their partners pregnant during the treatment period and within 12 months after the last administration.
Who cannot join
- The subject has a history of systemic anti-leukemia treatment for FL (including any curative radiotherapy for the purpose of cure);
- The subject has a history of aggressive B-cell lymphoma or has currently undergone histological transformation to DLBCL;
- FL 3b;
- The subject had suspected or confirmed primary CNS tumor at screening or had evidence of known CNS involvement;
- The subject has a history of severe allergic reaction or immediate severe allergic reaction to any component or excipient of zanubrutinib, lenalidomide, or rituximab;
- Has other tumors that affect the study medication or interfere with the results;
Show all 12Show fewer
- Received live vaccine within 28 days before treatment;
- Has reproductive capacity and is unwilling to use effective contraceptive measures;
- Pregnant or lactating women;
- Known human immunodeficiency virus (HIV) infection, or any serological status indicating active hepatitis B or hepatitis C virus infection: 1) HBV DNA positive. Positive for hepatitis B surface antigen (HBsAg) or serologically positive for hepatitis B core antibody (HBcAb), if HBV DNA is undetectable and is willing to undergo monthly HBV reactivation monitoring, then can be enrolled. 2) HCV antibody positive. For patients with HCV antibody, if HCV RNA is undetectable, then can be enrolled;
- Severe coagulation disorders and severe damage to organs such as heart, brain, lungs, liver, and kidneys;
- Had a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; has any life-threatening disease, medical condition, or organ system dysfunction that the subject considers may affect the safety of the subject or cause study risks.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Zanubrutinib Combined With Rituximab and Lenalidomide (ZR2) Versus R2 Regimen in the Treatment of Newly Diagnosed Follicular Lymphoma: A Randomized, Multicenter, Open-Label Phase II Clinical Study
Primary Objective: To compare the complete response rate (CR rate) after induction treatment between the ZR2 regimen and the R2 regimen.<br/><br/>Secondary Objectives: To compare the objective response rate (ORR) after induction treatment, progression-free survival (PFS), progression of disease within 24 months (POD24) rate, duration of response (DOR), overall survival (OS), treatment-related adverse events (AEs), and patient quality of life between the two groups.<br/><br/>Exploratory Objectives: To compare the histological .transformation (HT) rate at disease progression, minimal residual disease (MRD) negativity rate, changes in tumor microenvironment (TME) biomarkers, and the relationship between genetic biomarkers and efficacy/prognosis between the two groups; to further reveal the unique pattern of systemic immune status remodeling by the ZR2 regimen and identify potential efficacy-predictive biomarkers.
Study Nature Interventional study Study Design Prospective, randomized controlled, exploratory, multicenter clinical study Sample Size 100 cases Principal Investigator Professor Zhou Keshu Sponsor The Affiliated Cancer Hospital of Zhengzhou University Treatment Regimens (4 weeks per cycle) ZR2 Group<br/>- Induction Treatment (6 cycles): Zebutinib 160mg bid starting from C1D1; Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.<br/>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide ;ZR2 Group<br/>- Induction Treatment (6 cycles): Zebutinib 160mg bid starting from C1D1; Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.<br/>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide 10mg qd on Days 1-21 (once every 4 weeks for 12 times).<br/><br/>R2 Group<br/>- Induction Treatment (6 cycles): Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.<br/>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide 10mg qd on Days 1-21 (once every 4 weeks for 12 times).<br/><br/>Note: Patients who achieve PR during the first 6 cycles of induction treatment may receive an additional 3 to 6 cycles of lenalidomide 20mg until CR is achieved; thereafter, during maintenance treatment, lenalidomide 10mg PO qd is administered on Days 1-21 (once every 4 weeks for 12 times).
Read more
Study Endpoints:Primary Endpoint: CR rate after induction treatment (assessed by the 2014 Lugano Classification for Non-Hodgkin Lymphomas).<br/><br/>Secondary Endpoints: ORR after induction treatment; PFS; POD24 rate; OS; DOR; treatment-related AEs; patient quality of life.<br/><br/>Exploratory Endpoints: HT rate at disease progression; MRD negativity rate; changes in TME biomarkers; relationship between genetic biomarkers and efficacy/prognosis.
Follow-up Schedule:All patients will be followed up for 2 years after completing treatment, once every 3 months.
- Conditions
- Follicular Lymphomas
- Being tested
- Zanubrutinib+R2, R2
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zanubrutinib+R2Drug
6 cycles (each cycle lasting 4 weeks): From cycle 1 to cycle 6 (daily), patients received 160 mg of Zanubrutinib twice daily by mouth; From cycle 1 to cycle 6 (on the first day), patients received 375 mg/m2 of Rituximab once every 4 weeks by intravenous injection; From cycle 1 to cycle 6, patients received 20 mg of Lenalidomide once daily by mouth from day 1 to day 21 (if the CrCl was less than 60 mL/min in the previous 2 cycles, the dose was reduced to 10 mg; if this dose was tolerated, it was increased to 20 mg in cycles 3 to 6); After 6 cycles, patients who achieved CR or PR continued to receive the following treatment in cycles 7 to 24: From cycle 7 to cycle 24, patients received 375 mg/m2 of Rituximab once every 8 weeks by intravenous injection (i.e., on the first day of every 2 cycles); From cycle 7 to cycle 18, patients received 10 mg of Lenalidomide once daily by mouth from day 1 to day 21.
R2Drug
R2, 6 cycles (each 4 weeks as one cycle): During the first 6 cycles (from the 1st day to the 6th week), receive rituximab 375 mg/m2 every 4 weeks by intravenous injection; from the 1st day to the 21st day of the 1st to 6th cycles, receive lenalidomide 20 mg once daily by oral administration (if the CrCl was less than 60 mL/min in the previous 2 cycles, reduce it to 10 mg; if this dose is tolerated, increase it to 20 mg in the 3rd to 6th cycles); After 6 cycles, patients who achieved CR or PR continue to receive the following administration: In the 7th to 24th cycles, receive rituximab 375 mg/m2 every 8 weeks by intravenous injection (i.e., administer every 1st day of every 2 cycles); From the 7th to the 18th cycle, from the 1st day to the 21st day, receive lenalidomide 10 mg once daily by oral administration. Note: Patients who achieved PR within the first 6 cycles can receive an additional 3 to a maximum of 6 cycles of lenalidomide 20 mg until achieving CR.
| Study group | Role | What they receive |
|---|---|---|
| ZR2 | Experimental | 6 cycles (each cycle lasting 4 weeks): From cycle 1 to cycle 6 (daily), patients received 160 mg of Zanubrutinib twice daily by mouth; From cycle 1 to cycle 6 (on the first day), patients received 375 mg/m2 of Rituximab once every 4 weeks by intravenous injection; From cycle 1 to cycle 6, patients received 20 mg of Lenalidomide once daily by mouth from day 1 to day 21 (if the CrCl was less than 60 mL/min in the previous 2 cycles, the dose was reduced to 10 mg; if this dose was tolerated, it was increased to 20 mg in cycles 3 to 6); After 6 cycles, patients who achieved CR or PR continued to receive the following treatment in cycles 7 to 24: From cycle 7 to cycle 24, patients received 375 mg/m2 of Rituximab once every 8 weeks by intravenous injection (i.e., on the first day of every 2 cycles); From cycle 7 to cycle 18, patients received 10 mg of Lenalidomide once daily by mouth from day 1 to day 21. Receives: Drug: Zanubrutinib+R2 |
| R2 | Active comparator | R2, 6 cycles (each 4 weeks as one cycle): During the first 6 cycles (from the 1st day to the 6th week), receive rituximab 375 mg/m2 every 4 weeks by intravenous injection; from the 1st day to the 21st day of the 1st to 6th cycles, receive lenalidomide 20 mg once daily by oral administration (if the CrCl was less than 60 mL/min in the previous 2 cycles, reduce it to 10 mg; if this dose is tolerated, increase it to 20 mg in the 3rd to 6th cycles); After 6 cycles, patients who achieved CR or PR continue to receive the following administration: In the 7th to 24th cycles, receive rituximab 375 mg/m2 every 8 weeks by intravenous injection (i.e., administer every 1st day of every 2 cycles); From the 7th to the 18th cycle, from the 1st day to the 21st day, receive lenalidomide 10 mg once daily by oral administration. Note: Patients who achieved PR within the first 6 cycles can receive an additional 3 to a maximum of 6 cycles of lenalidomide 20 mg until achieving CR. Receives: Drug: R2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start23 Mar 2026 (estimated)
- Primary completion23 Mar 2030 (estimated)
- Study completion23 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Follicular LymphomasStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KeshuZhou
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, KeshuZhou, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505849
- Sponsor's protocol ID
- 2025-776-003
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] Jacobsen E. Follicular lymphoma: 2023 update on diagnosis and management. Am J Hematol. 2022. 97(12): 1638-1651. [2] Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023. 108(3): 822-832. [3] Casulo C, Byrtek M, Dawson KL, et al. Early Relapse of Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Defines Patients at High Risk for Death: An Analysis From the National LymphoCare Study. J Clin Oncol. 2015. 33(23): 2516-22. [4] Day JR, Larson MC, Durani U, et al. Treatment patterns and outcomes in follicular lymphoma with POD24: an analysis from the LEO Consortium. Blood Adv. 2025. 9(5): 1013-1023. [5] Sarkozy C, Trneny M, Xerri L, et al. Risk Factors and Outcomes for Patients With Follicular Lymphoma Who Had Histologic Transformation After Response to First-Line Immunochemotherapy in the PRIMA Trial. J Clin Oncol. 2016. 34(22): 2575-82. [6] Lu G, Middleton RE, Sun H, et al. The myeloma drug lenalidomide promotes the cereblon-dependent destruction of Ikaros proteins. Science. 2014. 343(6168): 305-9. [7] Ramsay AG, Clear AJ, Fatah R, Gribben JG. Multiple inhibitory ligands induce impaired T-cell immunologic synapse function in chronic lymphocytic leukemia that can be blocked with lenalidomide: establishing a reversible immune evasion mechanism in human cancer. Blood. 2012. 120(7): 1412-21. [8] Morschhauser F, Nastoupil L, Feugier P, et al. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R(2)) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022. 40(28): 3239-3245. [9] Küppers R. Mechanisms of B-cell lymphoma pathogenesis. Nat Rev Cancer. 2005. 5(4): 251-62. [10] Cheng G, Ye ZS, Baltimore D. Binding of Bruton's tyrosine kinase to Fyn, Lyn, or Hck through a Src homology 3 domain-mediated interactio
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanubrutinib Combined With Rituximab and Lenalidomide (ZR2) Versus R2 Regimen in the Treatment of Newly Diagnosed Follicular Lymphoma: A Randomized, Multicenter, Open-Label Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07505849
- Acronym / sponsor ID
- 2025-776-003
- Conditions
- Follicular Lymphomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- KeshuZhouOther government
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 23 Mar 2030 (estimated)
- Study completion
- 23 Mar 2030 (estimated)
- First posted
- 1 Apr 2026 (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.
Primary Objective: To compare the complete response rate (CR rate) after induction treatment between the ZR2 regimen and the R2 regimen.<br/><br/>Secondary Objectives: To compare the objective response rate (ORR) after induction treatment, progression-free survival (PFS), progression of disease within 24 months (POD24) rate, duration of response (DOR), overall survival (OS), treatment-related adverse events (AEs), and patient quality of life between the two groups.<br/><br/>Exploratory Objectives: To compare the histological .transformation (HT) rate at disease progression, minimal residual disease (MRD) negativity rate, changes in tumor microenvironment (TME) biomarkers, and the relationship between genetic biomarkers and efficacy/prognosis between the two groups; to further reveal the unique pattern of systemic immune status remodeling by the ZR2 regimen and identify potential efficacy-predictive biomarkers.
Study Nature Interventional study Study Design Prospective, randomized controlled, exploratory, multicenter clinical study Sample Size 100 cases Principal Investigator Professor Zhou Keshu Sponsor The Affiliated Cancer Hospital of Zhengzhou University Treatment Regimens (4 weeks per cycle) ZR2 Group<br/>- Induction Treatment (6 cycles): Zebutinib 160mg bid starting from C1D1; Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.<br/>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide ;ZR2 Group<br/>- Induction Treatment (6 cycles): Zebutinib 160mg bid starting from C1D1; Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.<br/>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide 10mg qd on Days 1-21 (once every 4 weeks for 12 times).<br/><br/>R2 Group<br/>- Induction Treatment (6 cycles): Rituximab 375mg/m² on Day 1; Lenalidomide 20mg qd on Days 1-21.<br/>- Maintenance Treatment: Rituximab 375mg/m² on Day 1 (once every 8 weeks for 2 years); Lenalidomide 10mg qd on Days 1-21 (once every 4 weeks for 12 times).<br/><br/>Note: Patients who achieve PR during the first 6 cycles of induction treatment may receive an additional 3 to 6 cycles of lenalidomide 20mg until CR is achieved; thereafter, during maintenance treatment, lenalidomide 10mg PO qd is administered on Days 1-21 (once every 4 weeks for 12 times).
Study Endpoints:Primary Endpoint: CR rate after induction treatment (assessed by the 2014 Lugano Classification for Non-Hodgkin Lymphomas).<br/><br/>Secondary Endpoints: ORR after induction treatment; PFS; POD24 rate; OS; DOR; treatment-related AEs; patient quality of life.<br/><br/>Exploratory Endpoints: HT rate at disease progression; MRD negativity rate; changes in TME biomarkers; relationship between genetic biomarkers and efficacy/prognosis.
Follow-up Schedule:All patients will be followed up for 2 years after completing treatment, once every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZR2 | Experimental | Drug: Zanubrutinib+R26 cycles (each cycle lasting 4 weeks): From cycle 1 to cycle 6 (daily), patients received 160 mg of Zanubrutinib twice daily by mouth; From cycle 1 to cycle 6 (on the first day), patients received 375 mg/m2 of Rituximab once every 4 weeks by intravenous injection; From cycle 1 to cycle 6, patients received 20 mg of Lenalidomide once daily by mouth from day 1 to day 21 (if the CrCl was less than 60 mL/min in the previous 2 cycles, the dose was reduced to 10 mg; if this dose was tolerated, it was increased to 20 mg in cycles 3 to 6); After 6 cycles, patients who achieved CR or PR continued to receive the following treatment in cycles 7 to 24: From cycle 7 to cycle 24, patients received 375 mg/m2 of Rituximab once every 8 weeks by intravenous injection (i.e., on the first day of every 2 cycles); From cycle 7 to cycle 18, patients received 10 mg of Lenalidomide once daily by mouth from day 1 to day 21. |
| R2 | Active comparator | Drug: R2R2, 6 cycles (each 4 weeks as one cycle): During the first 6 cycles (from the 1st day to the 6th week), receive rituximab 375 mg/m2 every 4 weeks by intravenous injection; from the 1st day to the 21st day of the 1st to 6th cycles, receive lenalidomide 20 mg once daily by oral administration (if the CrCl was less than 60 mL/min in the previous 2 cycles, reduce it to 10 mg; if this dose is tolerated, increase it to 20 mg in the 3rd to 6th cycles); After 6 cycles, patients who achieved CR or PR continue to receive the following administration: In the 7th to 24th cycles, receive rituximab 375 mg/m2 every 8 weeks by intravenous injection (i.e., administer every 1st day of every 2 cycles); From the 7th to the 18th cycle, from the 1st day to the 21st day, receive lenalidomide 10 mg once daily by oral administration. Note: Patients who achieved PR within the first 6 cycles can receive an additional 3 to a maximum of 6 cycles of lenalidomide 20 mg until achieving CR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily participate in the clinical study; fully understand and comprehend this study and sign the Informed Consent Form (ICF); willing to follow and capable of completing all study steps;
- According to the 5th edition of the WHO classification of hematological and lymphoid tumors, diagnosed as CD20+ classic FL (grade 1-3a FL) by histology, and no previous anti-FL treatment has been received;
- Age ≥ 18 years;
- Judged by the investigator, the subject must urgently need to receive systemic treatment, based on meeting at least one GELF criterion;
- At least one measurable lesion [longest diameter (LDi) ≥ 15mm, lymph node lesion LDi ≥ 10mm, evaluated according to the 2014 Lugano efficacy criteria];
Key exclusion criteria (12 listed)
- The subject has a history of systemic anti-leukemia treatment for FL (including any curative radiotherapy for the purpose of cure);
- The subject has a history of aggressive B-cell lymphoma or has currently undergone histological transformation to DLBCL;
- FL 3b;
- The subject had suspected or confirmed primary CNS tumor at screening or had evidence of known CNS involvement;
- The subject has a history of severe allergic reaction or immediate severe allergic reaction to any component or excipient of zanubrutinib, lenalidomide, or rituximab;
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 |
|---|---|---|
| Zanubrutinib+R26 cycles (each cycle lasting 4 weeks): From cycle 1 to cycle 6 (daily), patients received 160 mg of Zanubrutinib twice daily by mouth; From cycle 1 to cycle 6 (on the first day), patients received 375 mg/m2 of Rituximab once every 4 weeks by intravenous injection; From cycle 1 to cycle 6, patients received 20 mg of Lenalidomide once daily by mouth from day 1 to day 21 (if the CrCl was less than 60 mL/min in the previous 2 cycles, the dose was reduced to 10 mg; if this dose was tolerated, it was increased to 20 mg in cycles 3 to 6); After 6 cycles, patients who achieved CR or PR continued to receive the following treatment in cycles 7 to 24: From cycle 7 to cycle 24, patients received 375 mg/m2 of Rituximab once every 8 weeks by intravenous injection (i.e., on the first day of every 2 cycles); From cycle 7 to cycle 18, patients received 10 mg of Lenalidomide once daily by mouth from day 1 to day 21. | Drug | ZR2 |
| R2R2, 6 cycles (each 4 weeks as one cycle): During the first 6 cycles (from the 1st day to the 6th week), receive rituximab 375 mg/m2 every 4 weeks by intravenous injection; from the 1st day to the 21st day of the 1st to 6th cycles, receive lenalidomide 20 mg once daily by oral administration (if the CrCl was less than 60 mL/min in the previous 2 cycles, reduce it to 10 mg; if this dose is tolerated, increase it to 20 mg in the 3rd to 6th cycles); After 6 cycles, patients who achieved CR or PR continue to receive the following administration: In the 7th to 24th cycles, receive rituximab 375 mg/m2 every 8 weeks by intravenous injection (i.e., administer every 1st day of every 2 cycles); From the 7th to the 18th cycle, from the 1st day to the 21st day, receive lenalidomide 10 mg once daily by oral administration. Note: Patients who achieved PR within the first 6 cycles can receive an additional 3 to a maximum of 6 cycles of lenalidomide 20 mg until achieving CR. | Drug | R2 |
Primary outcome
CR rate
Time frame: 24weeks
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 1 Apr 2026.
- Background[1] Jacobsen E. Follicular lymphoma: 2023 update on diagnosis and management. Am J Hematol. 2022. 97(12): 1638-1651. [2] Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study. Haematologica. 2023. 108(3): 822-832. [3] Casulo C, Byrtek M, Dawson KL, et al. Early Relapse of Follicular Lymphoma After Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone Defines Patients at High Risk for Death: An Analysis From the National LymphoCare Study. J Clin Oncol. 2015. 33(23): 2516-22. [4] Day JR, Larson MC, Durani U, et al. Treatment patterns and outcomes in follicular lymphoma with POD24: an analysis from the LEO Consortium. Blood Adv. 2025. 9(5): 1013-1023. [5] Sarkozy C, Trneny M, Xerri L, et al. Risk Factors and Outcomes for Patients With Follicular Lymphoma Who Had Histologic Transformation After Response to First-Line Immunochemotherapy in the PRIMA Trial. J Clin Oncol. 2016. 34(22): 2575-82. [6] Lu G, Middleton RE, Sun H, et al. The myeloma drug lenalidomide promotes the cereblon-dependent destruction of Ikaros proteins. Science. 2014. 343(6168): 305-9. [7] Ramsay AG, Clear AJ, Fatah R, Gribben JG. Multiple inhibitory ligands induce impaired T-cell immunologic synapse function in chronic lymphocytic leukemia that can be blocked with lenalidomide: establishing a reversible immune evasion mechanism in human cancer. Blood. 2012. 120(7): 1412-21. [8] Morschhauser F, Nastoupil L, Feugier P, et al. Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R(2)) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma. J Clin Oncol. 2022. 40(28): 3239-3245. [9] Küppers R. Mechanisms of B-cell lymphoma pathogenesis. Nat Rev Cancer. 2005. 5(4): 251-62. [10] Cheng G, Ye ZS, Baltimore D. Binding of Bruton's tyrosine kinase to Fyn, Lyn, or Hck through a Src homology 3 domain-mediated interactio
- Individual participant dataSharing planned: No
Related trials for Follicular Lymphomas
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruiting
EXHIT ENTRE Implementation Trial of High Intensity Versus Low Intensity Strategy
Substance Use Disorders, Opioid Use Disorder, Severe
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin Lymphoma
Recruiting
STEpwise Research Program to Promote INGeniouS ONline Supportive Solutions in the Relief of Cancer-related Fatigue
Cancer Diagnosis, Moderate or Severe Score of Cancer-related Fatigue (CRF)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zanubrutinib+R2 and R2 in people with Follicular Lymphomas, run by KeshuZhou.
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 11 inclusion and 12 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 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Keshu Zhou Zhou (13674902391, drzhouks77@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CR rate (time frame: 24weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07505849, which also lists 1 linked publication.
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 1 Apr 2026.