Treatment for relapsed or refractory diffuse large B-cell lymphoma using a combination of drugs
Official title: The Efficiency and Safety of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Prospective, Single-arm, Multicenter Study
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06554600 · Data updated 2026-11-12
This study is testing a new combination of drugs to see if it can help people aged 18 to 75 with relapsed or refractory diffuse large B-cell lymphoma feel better and improve their chances of recovery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, Polatuzumab, rituximab, Zanubrutinib |
| Locations | 1 site (Hanzhou, Zhejiang) |
| Status | Recruiting |
| Started | August 31, 2024 |
| Main results expected | August 31, 2026 |
| Study ends | August 31, 2028 |
| Registry record updated | August 15, 2024 |
| Trial ID | NCT06554600 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 with relapsed or refractory diffuse large B-cell lymphoma who have measurable lesions and meet specific inclusion criteria.
✕Probably not a fit
Patients who have not been diagnosed with DLBCL or those who have not experienced relapse or refractory disease after initial treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II clinical trial investigates the efficacy and safety of a combination therapy involving Zanubrutinib, Polatuzumab Vedotin, Bendamustine, and Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Participants aged 18 to 75 will receive four courses of the Polo-ZBR regimen, followed by consolidation therapy for those who achieve a partial or complete response. After consolidation, patients will receive maintenance therapy with Zanubrutinib for one year, with follow-up lasting up to two years post-enrollment. The study aims to determine the effectiveness of this treatment approach in improving patient outcomes.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with relapsed or refractory DLBCL.
How similar studies have gone: Other studies have shown promising results with similar combination therapies in treating DLBCL, indicating potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged between 18 and 75 (inclusive); * For patients with DLBCL confirmed by histopathology (which needs to be confirmed by specimens after this or past recurrence), the following DLBCL histology will be considered eligible for study enrollment: DLBCL, NOS(includes GCB type and ABC type); T-cell rich large B-cell lymphoma; High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 rearrangement; High-grade B-cell lymphoma, NOS; Primary mediastinal (thymus) large B-cell lymphoma; EB virus positive DLBCL, NOS;HHV-8 positive DLBCL, NOS; * Relapsed refractory patients, defined as those who had no response after first-line treatment (including immunochemotherapy, chemotherapy or hematopoietic stem cell transplantation) or relapsed or refractory after remission; * There is at least one two-dimensional measurable lesion with a short diameter ≥1.0cm; * Estimated survival time ≥3 months; * The patient is informed and agrees to the program; * ECOG score 0-2 points; * Those who understand the procedure and content of the experiment, voluntarily participate in the study and sign the informed consent; * Patients can follow up on schedule, communicate well with researchers and complete the trial according to the trial regulations; * Confirm negative pregnancy test of female patients of childbearing age within 7 days before administration; Women and men in the reproductive period must agree to use medically recognized effective contraception throughout the treatment period and for 6 months after the end of the trial. Exclusion Criteria: * Active bleeding within 4 weeks prior to initial administration or anticoagulant therapy such as warfarin or vitamin K antagonists during the study period, or a tendency to bleed (such as esophageal varicose veins at risk of bleeding, locally active ulcerative lesions) or a clotting disorder deemed by the investigator; * Surgical procedures have been performed within 6 weeks prior to the signing of the informed consent for the first dose of the trial drug, but tests for diagnostic purposes are not considered surgical procedures, and the insertion of a vascular access device will be exempt from this exclusion criteria; * History of stroke and intracranial hemorrhage within 6 months before the first administration, except intracranial hemorrhage after surgery; * Those who cannot stop or adjust moderate or strong CYP3A inhibitors; * Have received organ transplantation or allogeneic stem cell transplantation; * Previous or concurrent history of other malignant tumors; * Chronic or currently active infectious diseases requiring systemic antibiotic, antifungal, or antiviral treatment (except EBV infections); * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, thrombotic diseases, connective tissue diseases and other diseases. Those who were not considered suitable for inclusion by the researchers; * Laboratory test value at screening (unless due to lymphoma) : Leukocyte count \< 3.5×109/L, neutrophils \<1.5×109/L, platelets \<80×109/L, hemoglobin \<100g/L, ALT or AST were 2.5 times higher than the upper limit of normal, bilirubin was 1.5 times higher than the upper limit of normal, creatinine level was 1.5 times higher than the upper limit of normal; * HbsAg positive patients need to check HBV-DNA \< 104 to be enrolled. In addition, if HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV-DNA testing is also required, and HBV-DNA results \< 104 are required to be enrolled and continue treatment and monitoring of HBV-DNA. Patients with HCV antibody positive were required to check HCV-RNA quantitative DNA \< 103 to be enrolled; * HIV antibody, treponema pallidum antibody positive; * Pregnant or lactating women; * Those who have a history of drug use or drug abuse upon inquiry; * Patient communication, understanding and cooperation are not enough, or compliance is poor, and it cannot be guaranteed that the program is carried out according to the requirements; * Known allergy to the investigational drug or its related ingredients; * Patients with past or current lymphoma central invasion; * The patient is unable to swallow the capsule or has a disease or condition that severely affects gastrointestinal function, such as malabsorption syndrome, removal of the stomach or small intestine, or complete intestinal obstruction; * Patients who could not stop using any other antitumor drugs within 2 weeks prior to medication in this study; * Participants considered unsuitable for this clinical trial due to various other reasons.
Where it's running
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2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Xianggui Yuan
- Email: yuanxg@zju.edu.cn
- Phone: +8613989883884
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Polatuzumab vedotin with Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in untreated DLBCL (MCD/BN2/N1)
This study tests a targeted combination therapy to see if it can treat previously untreated DLBCL with specific molecular subtypes.
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Comparing Pola-ZR2 and ZR2 for treating elderly patients with diffuse large B-cell lymphoma
This study is testing if adding a new drug called polatuzumab vedotin to a standard treatment helps older patients with diffuse large B-cell lymphoma feel better and improve their outcomes.
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Polatuzumab Vedotin plus Rituximab with Reduced-dose chemo for frail seniors with DLBCL
This trial tests whether a gentler, first-line treatment (Polatuzumab Vedotin with Rituximab and reduced-dose chemo) helps older, frail patients with DLBCL stay disease-free longer.
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Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL
This trial tests whether adding orelabrutinib to the Pola-R-CHP regimen can improve outcomes for adults with intermediate- to high-risk newly diagnosed DLBCL.
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Pola-ZR-Glo for older patients with large B‑cell lymphoma
This trial will try combining polatuzumab vedotin, zanubrutinib, lenalidomide, and glofitamab as first-line treatment for people aged 70 and older with newly diagnosed large B‑cell lymphoma who are unfit for standard chemo or decline immunochemotherapy.
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Zanubrutinib, rituximab, lenalidomide plus tislelizumab for relapsed/refractory follicular lymphoma
This trial tests whether adding the PD‑1 blocker tislelizumab to zanubrutinib, rituximab, and lenalidomide helps adults with relapsed or refractory follicular lymphoma who have had at least two prior therapies.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.