Non-GCB/ABC Diffuse Large B-Cell LymphomaPhase 2NCT04835870
Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL
A Phase 2 study testing Zanubrutinib, Rituximab and Cyclophosphamide in people with Non-GCB/ABC Diffuse Large B-Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 16 sites in China.
Trial summary
Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-GCB/ABC Diffuse Large B-Cell Lymphoma
- What is being tested?
- Zanubrutinib, Rituximab and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 16 sitesChina
- Study dates
- 1 Apr 2021to 1 Oct 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 Non-GCB DLBCL with extrinsic involvement
- Age ≥ 18 years
- Measurable disease of at least 15mm(node)/10mm（extranodal）
- ECOG performance status 0-2
- Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN
- Adequate bone marrow function:Platelet count (≥ 50×10^9/L);Hemoglobin (≥ 8 g/dL);The absolute value of neutrophils (≥1.0×10^9/L)
- Estimated survival time ≥3 months
- Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study
Who cannot join
- Accepted major surgery within 4 weeks before treatment;
- Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
- Previous history of indolent lymphoma;
- Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
- History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
- Requires treatment with a strong/medium CYP3A inducer;
Show all 12Show fewer
- The previous use of anthracycline-based drugs > 150 mg/m2;
- Evidence of complications or medical conditions, including but not limited, that may interfere the conduct of the study or place the patient at serious risk:significant cardiovascular disease(class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification、myocardial infarction within 6 months of screening、uncontrolled or symptomatic arrhythmias) and/or significant lung disease;
- HIV infection and/or active hepatitis B or active hepatitis C;
- Uncontrolled systemic infection;
- Pregnant or breasting-feeding women;
- According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
China16 sites, 16 recruiting
- Recruiting
The First People's Hospital of Changzhou
Changzhou, Jiangsu
Weiying Gu, 0519-68870000, guweiying2001@163.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian
Jianda Hu, +86-0591-83357896, drjiandahu@163.com
- Recruiting
The First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, Anhui
Xingbing Wang, +86-0551-62283160, wangxingbing@ustc.edu.cn
- Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
Xin Wang, +86-0531-82169114, xinw007@126.com
- Recruiting
Jiangsu Cancer Hospital
Nanjing, Jiangsu
Jianqiu Wu, +86-025-83283597, wujq211@163.com
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Jingyan Xu, +86-025-83106666, xjy1967@sina.com
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Zheng Ge, +86-025-8372111, gezheng2008@163.com
- Recruiting
Nantong Tumor Hospital
Nantong, Jiangsu
Xiaohong Xu, +86-0513-86712105, xhx107@163.com
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Caixia Li
- Recruiting
Changshu No.1 People's Hospital
Suzhou, Jiangsu
Guifang Zhang, +86-0512-52773259, 1194366857@qq.com
- Recruiting
Suzhou Hongci Hematology Hospital
Suzhou, Jiangsu
Ting Xu, +86-0512-83837999, 21132075@qq.com
Xiaochen Chen, +86-0512-83837999, chenxiabcd100@163.com
- Recruiting
Zhangjiagang First Peoples Hospital
Suzhou, Jiangsu
Qiurong Zhang, +86-0512-56919999, zhangqr1982@163.com
- Recruiting
Affiliated Hospital Of Jiangnan University
Wuxi, Jiangsu
Haiying Hua, +86-0510-68088900, huahy007@163.com
- Recruiting
Wuxi People's Hospital
Wuxi, Jiangsu
Xin Zhou, +86-0510-82700775, 13358111962@189.com
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Bing Xu, 0592-2137275, xubingzhangjian@126.com
- Recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu
Yan Xue, +86-0516-85790126, xueyanxz@163.com
About this study
Official title: Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL
Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients
Read the detailed description
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. This study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients.
- Being tested
- Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine
- Keywords
- Zanubrutinib, R-CHOP, Newly diagnosed Non-GCB DLBCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called BTK inhibitors
Zanubrutinib-160mg bid PO d0-d20(1-21d)
RituximabDrug
Also called MabThera
Rituximab-375 mg/m2 i.v d0 (/21d)
CyclophosphamideDrug
Also called CTX
Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
DoxorubicinDrug
Also called ADM
Doxorubicin-50 mg/m2 i.v d1 (/21d)
VincristineDrug
Also called VCR
Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
PrednisoneDrug
Also called Prednisonum
Prednisone-100 mg p.o d1-d5 (/21d)
| Study group | Role | What they receive |
|---|---|---|
| R-CHOP + Zanubrutinib | Experimental | Zanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) Receives: Drug: Zanubrutinib; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival(PFS)
To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
Measured: up to 18 months
Secondary outcomes (5)
Overall Response Rate (ORR)
To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
Measured: up to 18 months
Complete Response Rate
Number of patients who achieved complete response after treatment by ZR-CHOP
Measured: up to 18 months
Duration of Response
Duration of overall response will be assessed from the first ZR-CHOP given to progression,death or last follow-up.
Measured: up to 18 months
Overall Survival
OS will be assessed from the first ZR-CHOP given to death or last follow-up.
Measured: up to 18 months
Adverse events profile
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated
Measured: Measured from start of treatment until 28 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 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-GCB/ABC Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- 78 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Depei Wu, M.D, Study chair, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835870
- Sponsor's protocol ID
- ZR-CHOP
- Status last verified
- Mar 2022
- First submitted
- 5 Apr 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Geng H, Jia S, Zhang Y, Li J, Yang Q, Zeng L, Zong X, Lu Y, Lu S, Zhou J, Li C, Wu D. Efficacy and safety of zanubrutinib plus R-CHOP in treatment of non-GCB DLBCL with extranodal involvement. Front Immunol. 2023 Aug 21;14:1219167. doi: 10.3389/fimmu.2023.1219167. eCollection 2023.
PubMed 37671152
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL
- ClinicalTrials.gov ID
- NCT04835870
- Acronym / sponsor ID
- ZR-CHOP
- Keywords
- Zanubrutinib, R-CHOP, Newly diagnosed Non-GCB DLBCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 8 Apr 2021 (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.
Aim of this study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients
Detailed description
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. This study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R-CHOP + Zanubrutinib | Experimental | Drug: Zanubrutinib, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: PrednisoneZanubrutinib plus Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed Non-GCB DLBCL with extrinsic involvement
- Age ≥ 18 years
- Measurable disease of at least 15mm(node)/10mm（extranodal）
- ECOG performance status 0-2
- Adequate organ function:Cardiac ejection fraction (EF) ≥ 50%;Creatinine clearance rate (≥30 mL/min) of serum creatinine; Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) ≤3 times ULN
Key exclusion criteria (12 listed)
- Accepted major surgery within 4 weeks before treatment;
- Diagnosis of primary mediastinal lymphoma or primary CNS lymphoma;
- Previous history of indolent lymphoma;
- Prior malignancy (other than DLBCL), except for cured malignant tumors with no active lesions for 3 years;Adequate treatment of inactive lesions in non-melanoma skin cancer 、malignant tonsilloma or carcinoma in situ;
- History of intracranial haemorrhage in preceding 6 months,requires or receiving anticoagulation with warfarin or equivalent antagonists;
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 |
|---|---|---|
| ZanubrutinibAlso: BTK inhibitorsZanubrutinib-160mg bid PO d0-d20(1-21d) | Drug | R-CHOP + Zanubrutinib |
| RituximabAlso: MabTheraRituximab-375 mg/m2 i.v d0 (/21d) | Drug | R-CHOP + Zanubrutinib |
| CyclophosphamideAlso: CTXCyclophosphamide-750 mg/m2 i.v d1 (/21d) | Drug | R-CHOP + Zanubrutinib |
| DoxorubicinAlso: ADMDoxorubicin-50 mg/m2 i.v d1 (/21d) | Drug | R-CHOP + Zanubrutinib |
| VincristineAlso: VCRVincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max) | Drug | R-CHOP + Zanubrutinib |
| PrednisoneAlso: PrednisonumPrednisone-100 mg p.o d1-d5 (/21d) | Drug | R-CHOP + Zanubrutinib |
Primary outcome
Progression-free Survival(PFS)
Time frame: up to 18 months
To measure the duration of response to ZR-CHOP over a follow-up period of 18 months
5 secondary outcomes
Overall Response Rate (ORR)
Time frame: up to 18 months
Complete Response Rate
Time frame: up to 18 months
Duration of Response
Time frame: up to 18 months
Overall Survival
Time frame: up to 18 months
Adverse events profile
Time frame: Measured from start of treatment until 28 days after last dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Derived from this study: PubMed 37671152Geng H, Jia S, Zhang Y, Li J, Yang Q, Zeng L, Zong X, Lu Y, Lu S, Zhou J, Li C, Wu D. Efficacy and safety of zanubrutinib plus R-CHOP in treatment of non-GCB DLBCL with extranodal involvement. Front Immunol. 2023 Aug 21;14:1219167. doi: 10.3389/fimmu.2023.1219167. eCollection 2023.
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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.
Depei Wu, M.D study chair
The First Affiliated Hospital of Soochow University
16 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, Rituximab and Cyclophosphamide in people with Non-GCB/ABC Diffuse Large B-Cell Lymphoma, run by The First Affiliated Hospital of Soochow University at 16 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 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: status not confirmed, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 Caixia Li, M.D (+86 512 67781856, licaixia@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival(PFS) (time frame: up to 18 months). 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 NCT04835870, 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 16 Sep 2022.