Diffuse Large B Cell LymphomaPhase 2NCT05887726
Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors
A Phase 2 study testing Zanubrutinib, Rituximab and Cyclophosphamide in people with Diffuse Large B Cell Lymphoma, run by Liaoning Cancer Hospital & Institute at 1 site in China.
Trial summary
This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 1 Aug 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 DLBCL patients have one of the following risk factors(including but not limited to double expression, extranodal involvement, high ki67, bulky)；
- Age ≥ 18 years old;
- At least one measurable lesion (defined as lymph node lesion ≥15mm, extra-segmental lesions ≥ 10mm);
- ECOG performance status 0-2;
- Functions of major organs meet the following conditions: Echocardiography left ventricular ejection fraction ≥50%; Creatinine clearance ≥30 ml/min; ALT and AST≤3 times the normal range；
- Hematopoietic function should meet the following conditions: Platelet count ≥50×109/L; Hemoglobin ≥ 8.0g /dL; Absolute count of neutrophil (ANC)≥1.0×109/L;
- Expected survival of ≧3 months
Who cannot join
- Major surgery within 4 weeks before treatment;
- Severe organ dysfunction(including but not limited to complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases);
- Patients who cannot cooperate with treatment or follow-up on time.
- Pregnant or lactating females;
- any uncontrolled active systemic infection requiring intravenous (IV) antibiotics;
- There was a history of other active malignant diseases within the 2 years prior to study entry, except for: (1) adequately treated cervical carcinoma in situ; (2) local skin basal cell carcinoma or squamous cell carcinoma; (3) previous malignant disease that is under control and has undergone local radical treatment (surgical or other forms).
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- History of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von Willebrand's disease, or spontaneous bleeding requiring blood transfusion or other medical intervention
- Human immunodeficiency virus (HIV) infection or the following serological status reflecting the presence of active hepatitis B or C virus infection: a. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) are present. Patients who are HBCAB-positive, HBsAg negative, have no hepatitis b virus (HBV) DNA (< 20 IU/mL), and agree to be monitored for HBV virus reactivation can be enrolled. Antibodies to the hepatitis C virus (HCV) are present. HCV antibody-positive patients with no HCV RNA detected could be included in the group.
- The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes may affect the subject's safety or pose a risk to the study.
- The researchers think it is not suitable to participate in this experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors
This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Zanubrutinib, Rituximab, Cyclophosphamide, Epirubicin, Vincristine
- 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
Zanubrutinib 160mg bid p.o d0-d20(21-day cycles)
RituximabDrug
Rituximab 375 mg/m2 i.v d0(21-day cycles)
CyclophosphamideDrug
Cyclophosphamide 750 mg/m2 i.v d1(21-day cycles)
EpirubicinDrug
Epirubicin 75 mg/m2 i.v d1 or liposome adriamycin 35mg/m2 i.v d1(21-day cycles)
VincristineDrug
Vincristine 1.4 mg/m2 i.v d1 (2 mg max) (21-day cycles)
PrednisoneDrug
Prednisone 100 mg p.o d1-d5 (21-day cycles)
| Study group | Role | What they receive |
|---|---|---|
| Zanubrutinib + R-CHOP | Experimental | Not described Receives: Drug: Zanubrutinib; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate（CRR）
Measured: Up to approximately 2.5 years
Secondary outcomes (6)
Overall response rate （ORR）
Measured: Up to approximately 2.5 years
Progression-free Survival(PFS)
Measured: Up to approximately 2.5 years
Overall survival (OS)
Measured: Up to approximately 2.5 years
Duration of Response
Measured: At 2 years
Incidence of adverse event
Measured: At 2 years
Assessment of the correlation between MYD88、CD79B、NOTCH1、BCL6、NOTCH2 or other gene abnormality and efficacy.
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 posted5 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaoning Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojing Xing, Ph.D, Principal investigator, Liaoning Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887726
- Sponsor's protocol ID
- ZR-CHOP HR
- Status last verified
- Feb 2023
- First submitted
- 20 Mar 2023
- Last updated
- 27 Jul 2023
- 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 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors
- ClinicalTrials.gov ID
- NCT05887726
- Acronym / sponsor ID
- ZR-CHOP HR
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liaoning Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Jun 2023 (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 prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanubrutinib + R-CHOP | Experimental | Drug: Zanubrutinib, Drug: Rituximab, Drug: Cyclophosphamide, Drug: Epirubicin, Drug: Vincristine, Drug: Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed DLBCL patients have one of the following risk factors(including but not limited to double expression, extranodal involvement, high ki67, bulky)；
- Age ≥ 18 years old;
- At least one measurable lesion (defined as lymph node lesion ≥15mm, extra-segmental lesions ≥ 10mm);
- ECOG performance status 0-2;
- Functions of major organs meet the following conditions: Echocardiography left ventricular ejection fraction ≥50%; Creatinine clearance ≥30 ml/min; ALT and AST≤3 times the normal range；
Key exclusion criteria (10 listed)
- Major surgery within 4 weeks before treatment;
- Severe organ dysfunction(including but not limited to complications of uncontrolled cardiovascular diseases, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases);
- Patients who cannot cooperate with treatment or follow-up on time.
- Pregnant or lactating females;
- any uncontrolled active systemic infection requiring intravenous (IV) antibiotics;
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 |
|---|---|---|
| ZanubrutinibZanubrutinib 160mg bid p.o d0-d20(21-day cycles) | Drug | Zanubrutinib + R-CHOP |
| RituximabRituximab 375 mg/m2 i.v d0(21-day cycles) | Drug | Zanubrutinib + R-CHOP |
| CyclophosphamideCyclophosphamide 750 mg/m2 i.v d1(21-day cycles) | Drug | Zanubrutinib + R-CHOP |
| EpirubicinEpirubicin 75 mg/m2 i.v d1 or liposome adriamycin 35mg/m2 i.v d1(21-day cycles) | Drug | Zanubrutinib + R-CHOP |
| VincristineVincristine 1.4 mg/m2 i.v d1 (2 mg max) (21-day cycles) | Drug | Zanubrutinib + R-CHOP |
| PrednisonePrednisone 100 mg p.o d1-d5 (21-day cycles) | Drug | Zanubrutinib + R-CHOP |
Primary outcome
Complete response rate（CRR）
Time frame: Up to approximately 2.5 years
6 secondary outcomes
Overall response rate （ORR）
Time frame: Up to approximately 2.5 years
Progression-free Survival(PFS)
Time frame: Up to approximately 2.5 years
Overall survival (OS)
Time frame: Up to approximately 2.5 years
Duration of Response
Time frame: At 2 years
Incidence of adverse event
Time frame: At 2 years
Assessment of the correlation between MYD88、CD79B、NOTCH1、BCL6、NOTCH2 or other gene abnormality and efficacy.
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 27 Jul 2023.
- 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.
Xiaojing Xing, Ph.D principal investigator
Liaoning Cancer Hospital & Institute
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, Rituximab and Cyclophosphamide in people with Diffuse Large B Cell Lymphoma, run by Liaoning Cancer Hospital & Institute 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 7 inclusion and 10 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 27 Jul 2023. 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?
Contact Xiaojing Xing, Ph.D (18900917660, 13940066477@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate（CRR） (time frame: Up to approximately 2.5 years). 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 27 Jul 2023.