Polatuzumab with zanubrutinib, rituximab, lenalidomide and prednisone as first-line treatment for diffuse large B-cell lymphoma
Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma
This trial tests whether adding polatuzumab, zanubrutinib, rituximab, lenalidomide, and prednisone is safe and effective as initial treatment for adults with untreated diffuse large B-cell lymphoma.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06664411 on ClinicalTrials.gov |
What this trial studies
This phase 2 trial gives a five-drug combination—polatuzumab vedotin, zanubrutinib, rituximab, lenalidomide, and prednisone—as induction therapy to adults with previously untreated diffuse large B-cell lymphoma. Patients will receive the regimen as their initial chemotherapy and be followed for overall response rate, progression-free survival, overall survival, and adverse events. Eligible participants are adults with pathologically confirmed DLBCL who have not had prior chemotherapy and meet standard safety criteria. The study is conducted at Navy General Hospital in Beijing.
Who should consider this trial
Good fit: Adults aged 18 or older with pathologically confirmed, previously untreated diffuse large B-cell lymphoma who are medically fit for combination therapy and meet the trial's safety criteria are ideal candidates.
Not a fit: Patients with active uncontrolled infections, unstable severe organ dysfunction, or who are pregnant or lactating are unlikely to be eligible and may not benefit from this regimen.
Why it matters
Potential benefit: If successful, this combination could produce higher response rates and longer progression-free survival for patients with untreated DLBCL.
How similar studies have performed: Components of this regimen (polatuzumab combinations and lenalidomide plus rituximab) have shown activity in DLBCL in other studies, but the specific five-drug combination is relatively novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically confirmed Diffuse Large B Cell Lymphoma according World Health Organization (WHO) classification; * Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF). * Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted; * Patient is willing and able to adhere to the study visit schedule and other protocol requirements; * Patient has not received chemotherapy previously. * Anticipated life expectancy at least 3 months Exclusion Criteria: * Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment. * Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy. * Pregnant or lactating women
Where this trial is running
Beijing, Beijing Municipality
- Navy General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Liren Qian, PhD — Navy General Hospital, Beijing
- Study coordinator: Liren Qian, PhD
- Email: qlr2007@126.com
- Phone: +861066947194
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.