Non Hodgkin LymphomaPhase 2ZR2-CHOPNCT05200312
A Phase II Study of Zanubrutinib, Lenalidomide Plus R-CHOP as the First-line Treatment for Diffused Large B-cell Lymphoma
A Phase 2 study testing Zanubrutinib, Lenalidomide and Rituximab in people with Non Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial summary
This study is a multi-center, open-label, single-arm, non-randomized phase II clinical study in order to evaluate the safety and efficacy of zanubrutinib, lenalidomide plus R-CHOP (ZR2-CHOP) as the first-line therapy for treatment-naive high-risk diffuse large B-cell lymphoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
- What is being tested?
- Zanubrutinib, Lenalidomide and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2022to 1 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed and previously untreated Diffuse Large B-cell Lymphoma (DLBCL) with median to high risk (including but not limited to double/triple-hit, double expression and median-to-high risk aaIPI).
- Male or female patients above 18 years old.
- No prior exposure to treatment except a limited-field radiotherapy, short-term use of glucocorticoid =<25mg/day prednisone equivalent (must discontinue prior to day 1 of cycle 1) and/or cyclophosphamide due to an urgent lymphoma-related clinical situation (e.g. epidural spinal cord compression, superior vena caval syndrome and etc.).
- At least one measurable disease, as defined as radiographically apparent disease with the longest axis >=1.5cm.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3 (Patients with ECOG PS 3 should only be included if investigators deem that decline of status due to lymphoma and is reversible).
- Serum bilirubin <1.5 Upper Limit of Normal (ULN), other than gilbert syndrome (defined as unconjugated bilirubin >80%); Aspartate transaminase (AST) and Alanine aminotransferase (ALT) ≤3 ULN or <5 ULN (if abnormality due to lymphoma).
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- Enough reserve function of bone marrow, regarded as absolute neutrophil count (ANC) > 1.0×109/L and Platelets > 75 ×109/L except that abnormality is due to lymphoma involvement in the bone marrow and felt reversible by investigators.
- Creatinine clearance rate (Ccr) ≥30 ml / min calculated by Cockcroft-Gault formula.
- Patients must give consent to transfusions of blood products.
- Able to take aspirin (100mg) or alternative therapy daily as prophylactic anticoagulation.
- With life expectancy more than 3 months.
- All study participants must give consent to follow-up. Patients are fully aware of disease they have and sign informed consent on their own in order to join this study and receive treatment and follow-up.
Who cannot join
- Any serious medical condition including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure within past 6 months prior to screening (class 3 [moderate] or class 4 [severe] cardiac disease as defined by the New York Heart Association Functional Classification), uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), left ventricular ejection fraction (LVEF) less than 55%, renal failure, active infection, history of invasive fungal infection, moderate to severe hepatic disease (Child Pugh class B or C), active hemorrhage, laboratory abnormality, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form; patients with history of cardiac arrhythmias should have cardiac evaluation and clearance.
- Pregnant or lactating females.
- Known hypersensitivity to lenalidomide or thalidomide, Bruton's Tyrosine Kinase (BTK) inhibitor, rituximab, vincristine, doxorubicin, cyclophosphamide, or prednisone.
- Patients with active hepatitis B infection (HBV-DNA detectable) and active hepatitis C infection; patients with other acquired or congenital immunodeficiency disease, including but not limited to human immunodeficiency virus (HIV) infection.
- All patients with central nervous system involvement with lymphoma; patients with primary mediastinal large B cell lymphoma; patients with Richter Syndrome (aggressive DLBCL transformed from indolent CLL).
- Patients diagnosed as other malignancy except lymphoma, not including:
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- Patients received curable treatment and no occurrence of active malignancy more than 5 years prior to study entry; successfully treated basal cell carcinoma without disease symptoms (except melanoma); successfully treated "in situ" cervix carcinoma.
- Significant neuropathy (grade 2 or grade 1 with pain) within 14 days prior to enrollment.
- Contraindication to any of the required concomitant drugs or supportive treatments or intolerance to hydration due to preexisting pulmonary or cardiac impairment including pleural effusion requiring thoracentesis or ascites requiring paracentesis not due to lymphoma.
- Patients with active pulmonary embolism or deep vein thrombosis (diagnosed within 30 days of study enrollment).
- Patients with severe bradycardia (heart rate < 40 beats per minute [bpm], hypotension, light-headedness, syncope).
- Major surgery within 3 weeks of study entry, or wound that is not healed from prior surgery or trauma.
- History of stroke or intracranial hemorrhage within 6 months prior to study entry.
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists.
- Requires chronic treatment with strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors.
- Vaccinated with live, attenuated vaccines within 4 weeks of study entry.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital
Nanjin, Jiangsu, 210029
Huayuan Zhu, PhD，MD, 86 25 68306034, huayuan.zhu@hotmail.com
Yeqin Sha, MD, yeqinsha@njmu.edu.cn
- Recruiting
First affiliation hospital of nanjing medical university
Nanjing, Jiangsu, 210000
huayuan zhu, PhD
About this study
Official title: A Phase II Study of the Bruton's Tyrosine Kinase Inhibitor, Zanubrutinib, in Combination With Lenalidomide Plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
This study is a multi-center, open-label, single-arm, non-randomized phase II clinical study in order to evaluate the safety and efficacy of zanubrutinib, lenalidomide plus R-CHOP (ZR2-CHOP) as the first-line therapy for treatment-naive high-risk diffuse large B-cell lymphoma patients.
- Being tested
- Zanubrutinib, Lenalidomide, Rituximab, Cyclophosphamide, Doxorubicin
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
160 mg capsules administered by mouth twice daily (21-day cycles).
LenalidomideDrug
25 mg capsules administered by mouth once daily on Day 1 to Day 10 of each cycle (21-day cycles)
RituximabDrug
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
CyclophosphamideDrug
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
DoxorubicinDrug
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
VincristineDrug
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Prednisone (or equivalent)Drug
40 mg/m2 capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Treatment-naive DLBCL | Experimental | Treatment-naive high-risk DLBCL patients will be enrolled. R/R2-CHOP were allowed in cycle 1 due to poor physical condition or liver and renal failure caused by lymphoma progression. Patients achieving Complete Remission (CR) or Partial Remission (PR) after 2 cycles will receive another 2 cycles. Patients achieving CR or PR after 4 cycles will finish 6 cycles. Patients achieving CR after 6 cycles with double-hit/triple-hit/double-expression/median to high risk aaIPI will undergo Autologous Stem Cell Transplantation (ASCT). Other patients will be administered rituximab for another 2 cycles and then turn to follow-up. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for another 3 years. Patients achieving Stable Disease (SD) or PD (Progression Disease) after 2 or 4 cycles will quit the study. After 6 cycles, patients achieving SD or PD will quit the study and patients achieving PR will receive second-line therapy. Receives: Drug: Zanubrutinib; Drug: Lenalidomide; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone (or equivalent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate after six cycles of ZR2-CHOP
Complete response rate will be assessed by (18)F-fluorodeoxyglucose (FDG) positron emission tomography (PET/CT) according to 2014 Lugano Criteria.
Measured: at the end of 6 cycles(each cycle is 21 days)
Secondary outcomes (7)
Progression-Free Survival (PFS) two years follow-up
PFS was defined as the duration from the date of randomization to the date of progression, relapse from CR, or death, whichever occurred first. Responses were based on 2014 Lugano Criteria.
Measured: At 2 years
Overall survival (OS) two years follow-up
Overall survival was defined as the duration from the date of randomization to the date of the participant's death. Median Overall Survival was estimated by using the Kaplan-Meier method.
Measured: At 2 years
Circulating tumor Deoxyribonucleic Acid (ctDNA) clearance rate
ctDNA will be measured at baseline and after 2, 4, 6 cycles of ZR2-CHOP
Measured: Baseline (At initial start), at the end of 2,4 ,6 cycles(each cycle is 21 days)
Overall response rate after six cycles of ZR2-CHOP
Overall response rate will be assessed by FDG-PET/CT or CT scan according to 2014 Lugano Criteria.
Measured: at the end of 6 cycles(each cycle is 21 days)
Overall response rate after two, four cycles of ZR2-CHOP
Overall response rate will be assessed by FDG-PET/CT according to 2014 Lugano Criteria.
Measured: at the end of 2,4 cycles(each cycle is 21 days)
Complete response rate after two, four cycles of ZR2-CHOP
Overall response rate will be assessed by FDG-PET/CT according to 2014 Lugano Criteria.
Measured: at the end of 2,4 cycles(each cycle is 21 days)
Incidence of adverse events
Toxicities will be summarized by grade and by their relationship to treatment according to CTCAE (version 5.0).
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Feb 2022
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2025 (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 Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianyong Li, Phd, MD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200312
- Sponsor's protocol ID
- CWCLL-003
- Acronym
- ZR2-CHOP
- Status last verified
- Mar 2022
- First submitted
- 17 Jan 2022
- Last updated
- 11 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xia Y, Miao Y, Qian S, Zhang R, Qin S, Xie X, Li B, Sha Y, Tang H, Jin H, Cao L, Xu W, Fan L, Li J, Shi W, Zhu H. Zanubrutinib, lenalidomide and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone as initial treatment in non-germinal center B-cell diffuse large B-cell lymphoma: a multi-center phase 2 study by Jiangsu Cooperative Lymphoma Group (JCLG). BMC Med. 2025 Oct 24;23(1):583. doi: 10.1186/s12916-025-04418-y.
PubMed 41136989
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Bruton's Tyrosine Kinase Inhibitor, Zanubrutinib, in Combination With Lenalidomide Plus Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05200312
- Acronym / sponsor ID
- ZR2-CHOP / CWCLL-003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 20 Jan 2022 (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 is a multi-center, open-label, single-arm, non-randomized phase II clinical study in order to evaluate the safety and efficacy of zanubrutinib, lenalidomide plus R-CHOP (ZR2-CHOP) as the first-line therapy for treatment-naive high-risk diffuse large B-cell lymphoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment-naive DLBCL | Experimental | Drug: Zanubrutinib, Drug: Lenalidomide, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone (or equivalent)Treatment-naive high-risk DLBCL patients will be enrolled. R/R2-CHOP were allowed in cycle 1 due to poor physical condition or liver and renal failure caused by lymphoma progression. Patients achieving Complete Remission (CR) or Partial Remission (PR) after 2 cycles will receive another 2 cycles. Patients achieving CR or PR after 4 cycles will finish 6 cycles. Patients achieving CR after 6 cycles with double-hit/triple-hit/double-expression/median to high risk aaIPI will undergo Autologous Stem Cell Transplantation (ASCT). Other patients will be administered rituximab for another 2 cycles and then turn to follow-up. After completion of study treatment, patients are followed up every 3 months for 2 years, and then every 6 months for another 3 years. Patients achieving Stable Disease (SD) or PD (Progression Disease) after 2 or 4 cycles will quit the study. After 6 cycles, patients achieving SD or PD will quit the study and patients achieving PR will receive second-line therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically-confirmed and previously untreated Diffuse Large B-cell Lymphoma (DLBCL) with median to high risk (including but not limited to double/triple-hit, double expression and median-to-high risk aaIPI).
- Male or female patients above 18 years old.
- No prior exposure to treatment except a limited-field radiotherapy, short-term use of glucocorticoid =<25mg/day prednisone equivalent (must discontinue prior to day 1 of cycle 1) and/or cyclophosphamide due to an urgent lymphoma-related clinical situation (e.g. epidural spinal cord compression, superior vena caval syndrome and etc.).
- At least one measurable disease, as defined as radiographically apparent disease with the longest axis >=1.5cm.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3 (Patients with ECOG PS 3 should only be included if investigators deem that decline of status due to lymphoma and is reversible).
Key exclusion criteria (16 listed)
- Any serious medical condition including but not limited to uncontrolled hypertension, uncontrolled congestive heart failure within past 6 months prior to screening (class 3 [moderate] or class 4 [severe] cardiac disease as defined by the New York Heart Association Functional Classification), uncontrolled diabetes mellitus, active/symptomatic coronary artery disease, chronic obstructive pulmonary disease (COPD), left ventricular ejection fraction (LVEF) less than 55%, renal failure, active infection, history of invasive fungal infection, moderate to severe hepatic disease (Child Pugh class B or C), active hemorrhage, laboratory abnormality, or psychiatric illness that, in the investigators opinion places the patient at unacceptable risk and would prevent the subject from signing the informed consent form; patients with history of cardiac arrhythmias should have cardiac evaluation and clearance.
- Pregnant or lactating females.
- Known hypersensitivity to lenalidomide or thalidomide, Bruton's Tyrosine Kinase (BTK) inhibitor, rituximab, vincristine, doxorubicin, cyclophosphamide, or prednisone.
- Patients with active hepatitis B infection (HBV-DNA detectable) and active hepatitis C infection; patients with other acquired or congenital immunodeficiency disease, including but not limited to human immunodeficiency virus (HIV) infection.
- All patients with central nervous system involvement with lymphoma; patients with primary mediastinal large B cell lymphoma; patients with Richter Syndrome (aggressive DLBCL transformed from indolent CLL).
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 |
|---|---|---|
| Zanubrutinib160 mg capsules administered by mouth twice daily (21-day cycles). | Drug | Treatment-naive DLBCL |
| Lenalidomide25 mg capsules administered by mouth once daily on Day 1 to Day 10 of each cycle (21-day cycles) | Drug | Treatment-naive DLBCL |
| Rituximab375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles) | Drug | Treatment-naive DLBCL |
| Cyclophosphamide750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles) | Drug | Treatment-naive DLBCL |
| Doxorubicin50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles) | Drug | Treatment-naive DLBCL |
| Vincristine1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles) | Drug | Treatment-naive DLBCL |
| Prednisone (or equivalent)40 mg/m2 capsules administered by mouth once daily on Day 1 to Day 5 of each cycle | Drug | Treatment-naive DLBCL |
Primary outcome
Complete response rate after six cycles of ZR2-CHOP
Time frame: at the end of 6 cycles(each cycle is 21 days)
Complete response rate will be assessed by (18)F-fluorodeoxyglucose (FDG) positron emission tomography (PET/CT) according to 2014 Lugano Criteria.
7 secondary outcomes
Progression-Free Survival (PFS) two years follow-up
Time frame: At 2 years
Overall survival (OS) two years follow-up
Time frame: At 2 years
Circulating tumor Deoxyribonucleic Acid (ctDNA) clearance rate
Time frame: Baseline (At initial start), at the end of 2,4 ,6 cycles(each cycle is 21 days)
Overall response rate after six cycles of ZR2-CHOP
Time frame: at the end of 6 cycles(each cycle is 21 days)
Overall response rate after two, four cycles of ZR2-CHOP
Time frame: at the end of 2,4 cycles(each cycle is 21 days)
Complete response rate after two, four cycles of ZR2-CHOP
Time frame: at the end of 2,4 cycles(each cycle is 21 days)
Incidence of adverse events
Time frame: At 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Derived from this study: PubMed 41136989Xia Y, Miao Y, Qian S, Zhang R, Qin S, Xie X, Li B, Sha Y, Tang H, Jin H, Cao L, Xu W, Fan L, Li J, Shi W, Zhu H. Zanubrutinib, lenalidomide and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone as initial treatment in non-germinal center B-cell diffuse large B-cell lymphoma: a multi-center phase 2 study by Jiangsu Cooperative Lymphoma Group (JCLG). BMC Med. 2025 Oct 24;23(1):583. doi: 10.1186/s12916-025-04418-y.
- 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.
Jianyong Li, Phd, MD principal investigator
The First Affiliated Hospital with Nanjing Medical University
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 Zanubrutinib, Lenalidomide and Rituximab in people with Non Hodgkin Lymphoma and Diffuse Large B Cell Lymphoma, run by The First Affiliated Hospital with Nanjing Medical University 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 12 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: status not confirmed, as of the sponsor's last update on 11 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianyong Li, Phd, MD (025-83718836, lijianyonglm@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate after six cycles of ZR2-CHOP (time frame: at the end of 6 cycles(each cycle is 21 days)). 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 NCT05200312, 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 11 Mar 2022.