Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPNPhase 2ZGR in SBLPNNCT07165769
Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma With Prominent Nucleoli (SBLPN): A Prospective, Open-label, Single-arm Clinical Trial
A Phase 2 study testing Induction Therapy and Maintenance Therapy in people with Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPN, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
:The aim of this study was to analyze the safety and efficacy of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma with Prominent Nucleoli (SBLPN). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPN
- What is being tested?
- Induction Therapy and Maintenance Therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2025to 31 Dec 2029
- 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
- Histologically or cytologically confirmed SBLPN requiring active treatment;
- No prior systemic therapy for SBLPN received;
- ECOG performance status of 0-2;
- Anticipated life expectancy ≥6 months;
- Laboratory parameters (hematologic and biochemical) meeting the following criteria:
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- a. Absolute neutrophil count (ANC) ≥1.0 × 10⁹/L, platelet count ≥50 × 10⁹/L;
- b. Total bilirubin (TBIL) ≤2.0 × upper limit of normal (ULN);
- c. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN;
- d. Creatinine clearance ≥50 mL/min (calculated via Cockcroft-Gault formula or direct measurement).
- Men and women of childbearing potential must agree to use medically approved contraception throughout the study and for 4 weeks after treatment discontinuation;
- Participants must voluntarily enroll in the study and provide written informed consent.
Who cannot join
- History of central nervous system (CNS) disorders (including CNS lymphoma) diagnosed within 1 year prior to enrollment.
- Other primary malignancies within the past 3 years (excluding non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ, or squamous intraepithelial lesions on PAP smear).
- Exposure to any investigational drugs, antimicrobial agents, or participation in other interventional clinical trials within 4 weeks prior to enrollment.
- Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated requirement for major surgery during the study.
- Prior use of investigational agents targeting SBLPN.
- Active immunodeficiency, autoimmune diseases, prolonged systemic corticosteroid therapy (>10 mg/day prednisone equivalent) within 7 days prior to enrollment, or any immunosuppressive therapy.
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- Severe hepatic dysfunction (e.g., severe jaundice, hepatic encephalopathy, refractory ascites, hepatorenal syndrome), cachexia, multiorgan failure, or severe renal impairment.
- Clinically significant cardiovascular comorbidities:
- New York Heart Association (NYHA) class III/IV heart failure; Myocardial infarction within 6 months prior to enrollment; Uncontrolled arrhythmias (including QTc interval ≥480 ms); Poorly controlled hypertension (systolic ≥150 mmHg/diastolic ≥100 mmHg despite antihypertensives); Unstable angina.
- Bleeding diathesis or coagulation disorders; thrombotic events within 3 months prior to enrollment.
- Hypersensitivity to active ingredients or excipients of the investigational drugs.
- Pregnancy, lactation, or women of childbearing potential unwilling/unable to use contraception.
- Other conditions deemed unsuitable for participation by the investigator (e.g., compromised protocol compliance or safety risks).
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
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Yuting Yan
About this study
:The aim of this study was to analyze the safety and efficacy of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma with Prominent Nucleoli (SBLPN).
The main questions it aims to explore the Preliminary Efficacy of the Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) Regimen in the Treatment of Newly Diagnosed SBLPN Patients.
To explore the safety of zanubrutinib, obinutuzumab combined with lenalidomide (ZGR) in the treatment of newly diagnosed SBLPN patients.
Read the detailed description
There is no consensus on optimal first-line therapy for splenic B-cell lymphoproliferative neoplasms (SBLPN). Existing regimens like cladribine/bendamustine plus rituximab face toxicity and resistance. Targeting Bruton's tyrosine kinase (BTK), the novel BTK inhibitor zanubrutinib (highly selective, low toxicity) combined with obinutuzumab (enhanced antibody-dependent cytotoxicity) and lenalidomide (immunomodulation) shows promise. This single-arm trial evaluates the ZGR regimen (zanubrutinib, obinutuzumab, lenalidomide) for untreated SBLPN, including 6-cycle induction and maintenance therapy (zanubrutinib-lenalidomide), aiming to enhance efficacy, survival, and tolerability, offering a novel approach for this rare disease.
- Being tested
- Induction Therapy, Maintenance Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction TherapyDrug
All enrolled patients will receive the ZGR regimen (zanubrutinib, obinutuzumab, and lenalidomide) for induction therapy. Each cycle lasts 28 days, up to 6 cycles, followed by maintenance therapy. Patients experiencing disease progression during induction will discontinue the trial drugs but remain under survival follow-up.
- Zanubrutinib: 160 mg twice daily, administered orally continuously.
- Obinutuzumab: 1000 mg via intravenous infusion, administered on Days 1, 8, and 15 of Cycle 1 and subsequently on Day 1 of Cycles 2-6.
- Lenalidomide: 25 mg once daily, taken orally on Days 1-21 of each 28-day cycle until disease progression. Doses should be taken at approximately the same time daily.
Maintenance TherapyDrug
Maintenance therapy consists of zanubrutinib plus lenalidomide:
Lenalidomide is continued for 1 year. Zanubrutinib is continued for 2 years. Treatment continues until disease progression, intolerability, or completion of 2 years. For patients who do not achieve complete remission (CR), therapy may continue until progression or intolerability.
- Zanubrutinib: 160 mg twice daily, administered orally continuously.
- Lenalidomide: 10 mg once daily, taken orally on Days 1-21, followed by a 7-day rest period, constituting a 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Induction therapy and maintenance therapy of BGR | Experimental | 1. Induction Therapy Induction Therapy consists of zanubrutinib plus lenalidomide: each cycle lasts 28 days, up to 6 cycles, followed by maintenance therapy.
2. Maintenance Therapy Maintenance therapy consists of zanubrutinib plus lenalidomide: Lenalidomide is continued for 1 year. Zanubrutinib is continued for 2 years. Receives: Drug: Induction Therapy; Drug: Maintenance Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective 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)]
Secondary outcomes (6)
complete response rate，CRR
Measured: Up to the end of 9 cycles of treatment(each cycle is 28 days)
progression-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 response，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
Minimal Residual Disease，MRD
Measured: Up to the end of 2 years (each cycle is 28 days)
Adverse event rate
Measured: Up to the end of 2 years (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start4 Sep 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPNStudies 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
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuhua Yi, Dr, Principal investigator, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165769
- Sponsor's protocol ID
- IIT2025004
- Acronym
- ZGR in SBLPN
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 18 Dec 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma With Prominent Nucleoli (SBLPN): A Prospective, Open-label, Single-arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07165769
- Acronym / sponsor ID
- ZGR in SBLPN / IIT2025004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Sep 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.
:The aim of this study was to analyze the safety and efficacy of Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) in the Treatment of Newly Diagnosed Splenic B-cell Lymphoma with Prominent Nucleoli (SBLPN).
The main questions it aims to explore the Preliminary Efficacy of the Zanubrutinib, Obinutuzumab, and Lenalidomide (ZGR) Regimen in the Treatment of Newly Diagnosed SBLPN Patients.
To explore the safety of zanubrutinib, obinutuzumab combined with lenalidomide (ZGR) in the treatment of newly diagnosed SBLPN patients.
Detailed description
There is no consensus on optimal first-line therapy for splenic B-cell lymphoproliferative neoplasms (SBLPN). Existing regimens like cladribine/bendamustine plus rituximab face toxicity and resistance. Targeting Bruton's tyrosine kinase (BTK), the novel BTK inhibitor zanubrutinib (highly selective, low toxicity) combined with obinutuzumab (enhanced antibody-dependent cytotoxicity) and lenalidomide (immunomodulation) shows promise. This single-arm trial evaluates the ZGR regimen (zanubrutinib, obinutuzumab, lenalidomide) for untreated SBLPN, including 6-cycle induction and maintenance therapy (zanubrutinib-lenalidomide), aiming to enhance efficacy, survival, and tolerability, offering a novel approach for this rare disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction therapy and maintenance therapy of BGR | Experimental | Drug: Induction Therapy, Drug: Maintenance Therapy1. Induction Therapy Induction Therapy consists of zanubrutinib plus lenalidomide: each cycle lasts 28 days, up to 6 cycles, followed by maintenance therapy. 2. Maintenance Therapy Maintenance therapy consists of zanubrutinib plus lenalidomide: Lenalidomide is continued for 1 year. Zanubrutinib is continued for 2 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18 to 80 years, male or female
- Histologically or cytologically confirmed SBLPN requiring active treatment;
- No prior systemic therapy for SBLPN received;
- ECOG performance status of 0-2;
- Anticipated life expectancy ≥6 months;
Key exclusion criteria (13 listed)
- History of central nervous system (CNS) disorders (including CNS lymphoma) diagnosed within 1 year prior to enrollment.
- Other primary malignancies within the past 3 years (excluding non-melanoma skin cancer, curatively treated localized prostate cancer, cervical carcinoma in situ, or squamous intraepithelial lesions on PAP smear).
- Exposure to any investigational drugs, antimicrobial agents, or participation in other interventional clinical trials within 4 weeks prior to enrollment.
- Major surgery (excluding lymph node biopsy) within 14 days before enrollment or anticipated requirement for major surgery during the study.
- Prior use of investigational agents targeting SBLPN.
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 |
|---|---|---|
| Induction TherapyAll enrolled patients will receive the ZGR regimen (zanubrutinib, obinutuzumab, and lenalidomide) for induction therapy. Each cycle lasts 28 days, up to 6 cycles, followed by maintenance therapy. Patients experiencing disease progression during induction will discontinue the trial drugs but remain under survival follow-up. 1. Zanubrutinib: 160 mg twice daily, administered orally continuously. 2. Obinutuzumab: 1000 mg via intravenous infusion, administered on Days 1, 8, and 15 of Cycle 1 and subsequently on Day 1 of Cycles 2-6. 3. Lenalidomide: 25 mg once daily, taken orally on Days 1-21 of each 28-day cycle until disease progression. Doses should be taken at approximately the same time daily. | Drug | Induction therapy and maintenance therapy of BGR |
| Maintenance TherapyMaintenance therapy consists of zanubrutinib plus lenalidomide: Lenalidomide is continued for 1 year. Zanubrutinib is continued for 2 years. Treatment continues until disease progression, intolerability, or completion of 2 years. For patients who do not achieve complete remission (CR), therapy may continue until progression or intolerability. 1. Zanubrutinib: 160 mg twice daily, administered orally continuously. 2. Lenalidomide: 10 mg once daily, taken orally on Days 1-21, followed by a 7-day rest period, constituting a 28-day cycle. | Drug | Induction therapy and maintenance therapy of BGR |
Primary outcome
Objective response rate，ORR
Time frame: up to the end of 9 cycles of treatment(each cycle is 28 days)]
defined as the proportion of patients with complete or partial response as assessed by response to induction therapy.
6 secondary outcomes
complete response rate，CRR
Time frame: Up to the end of 9 cycles of treatment(each cycle is 28 days)
progression-free survival，PFS
Time frame: up to 5 years
duration of response，DOR
Time frame: up to 5 years
Overall survival，OS
Time frame: Up to 5 years
Minimal Residual Disease，MRD
Time frame: Up to the end of 2 years (each cycle is 28 days)
Adverse event rate
Time frame: Up to the end of 2 years (each cycle is 28 days)
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 18 Dec 2025.
- Individual participant dataSharing planned: No
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.
Shuhua Yi, Dr principal investigator
Institute of Hematology & Blood Diseases Hospital, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Induction Therapy and Maintenance Therapy in people with Splenic B-cell Lymphoma/Leukaemia With Prominent Nucleoli，SBLPN, run by Institute of Hematology & Blood Diseases Hospital, China 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 12 inclusion and 13 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 18 Dec 2025. 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. 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 Shuhua Yi, Dr (+86-022-23909106, yishuhua@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate，ORR (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 18 Dec 2025.