Diffuse Large B Cell LymphomaPhase 2NCT05290337
ZR-CHOP in DLBCL With Specific Gene Abnormality
A Phase 2 study testing zanubrutinib in people with Diffuse Large B Cell Lymphoma, run by Fudan University at 1 site in China.
Trial summary
This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- zanubrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2022to 4 Jan 2026
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-75 years old;
- histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation;
- Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center-
- normal hematological, hepatic and renal function.
- Life expectancy of more than 3 months;
- Patients had at least one measurable target lesion;
- LVEF ≥ 50%
- signed informed consent forms
Who cannot join
- hypersensitivity to immunoglobulin;
- primary central nerves lymphoma
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
- With contraindication of steroid including uncontrolled diabetes;
- Serious uncontrolled diseases and intercurrent infection;
- Pregnant or lactating women;
- hepatitis B infection with HBV-DNA ≥ 104
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Qunling Zhang, doctor, 64175590 ext. 88900, zqldoc@163.com
About this study
Official title: Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality
This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.
Read the detailed description
This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- zanubrutinib
- Keywords
- Zanubrutinib, gene mutation, MYC translocation
- Medical subject headings
- 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
BTK inhibitor
| Study group | Role | What they receive |
|---|---|---|
| ZR-CHOP | Experimental | Not described Receives: Drug: zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression free survival
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Measured: assessed up to 36 months
Secondary outcomes (3)
Objective response rate
complete remission and partial remission
Measured: assessed up to 36 months
3-year event free survival
From date of enrollment until the date of an event, including progression, death from any cause, new treatment.
Measured: assessed up to 36 months
3-year overall survival
From date of enrollment until the date of death from any cause
Measured: assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start4 Jan 2022
- Primary completion4 Jan 2024 (estimated)
- Study completion4 Jan 2026 (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 Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junning Cao, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290337
- Sponsor's protocol ID
- ZIDEA
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2022
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Q, Jiang S, Wei R, Zhang W, Bao L, Liu Y, Jin J, Lv F, Liu C, Liu X, Sun H, Wang J, Tao R, Zhou X, Cao J. Zanubrutinib combined with R-CHOP in previously untreated diffuse large B-cell lymphoma with specific gene alteration: a phase II study. Blood Cancer J. 2026 Jul 1. doi: 10.1038/s41408-026-01553-4. Online ahead of print.
PubMed 42386710
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality
- ClinicalTrials.gov ID
- NCT05290337
- Acronym / sponsor ID
- ZIDEA
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Zanubrutinib, gene mutation, MYC translocation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 4 Jan 2024 (estimated)
- Study completion
- 4 Jan 2026 (estimated)
- First posted
- 22 Mar 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 is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.
Detailed description
This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZR-CHOP | Experimental | Drug: zanubrutinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-75 years old;
- histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation;
- Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center-
- normal hematological, hepatic and renal function.
- Life expectancy of more than 3 months;
Key exclusion criteria (7 listed)
- hypersensitivity to immunoglobulin;
- primary central nerves lymphoma
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
- With contraindication of steroid including uncontrolled diabetes;
- Serious uncontrolled diseases and intercurrent infection;
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 |
|---|---|---|
| zanubrutinibBTK inhibitor | Drug | ZR-CHOP |
Primary outcome
3-year progression free survival
Time frame: assessed up to 36 months
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
3 secondary outcomes
Objective response rate
Time frame: assessed up to 36 months
3-year event free survival
Time frame: assessed up to 36 months
3-year overall survival
Time frame: assessed up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Derived from this study: PubMed 42386710Zhang Q, Jiang S, Wei R, Zhang W, Bao L, Liu Y, Jin J, Lv F, Liu C, Liu X, Sun H, Wang J, Tao R, Zhou X, Cao J. Zanubrutinib combined with R-CHOP in previously untreated diffuse large B-cell lymphoma with specific gene alteration: a phase II study. Blood Cancer J. 2026 Jul 1. doi: 10.1038/s41408-026-01553-4. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Diffuse Large B Cell Lymphoma
RecruitingPhase 1
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, High Grade B-Cell Lymphoma
Active, not recruitingPhase 2
Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma
RecruitingPhase 1
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma (DLBCL)
Active, not recruitingPhase 1
Cellular Immunotherapy Following Chemotherapy in Treating Patients With Recurrent Non-Hodgkin Lymphomas, Chronic Lymphocytic Leukemia, or B-Cell Prolymphocytic Leukemia
B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma, B-Cell Prolymphocytic Leukemia
RecruitingPhase 1
HEME-25 Open-Label Feasibility Study of Elranatamab Utilized as Consolidation in Newly Diagnosed Plasmablastic Lymphoma With or Without HIV
Plasmablastic Lymphoma, HIV
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.
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 zanubrutinib in people with Diffuse Large B Cell Lymphoma, run by Fudan University 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 8 inclusion and 7 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 22 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression free survival (time frame: assessed up to 36 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 NCT05290337, 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 22 Mar 2022.