Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 14 and up

Polatuzumab with zanubrutinib, rituximab, lenalidomide and prednisone as first-line treatment for diffuse large B-cell lymphoma

Official title: Polatuzumab Vedotin, Zanubrutinib, Rituximab, Lenalidomide and Prednisone in Previously Untreated Diffuse Large B-Cell Lymphoma

Run by Navy General Hospital, Beijing · NCT06664411 · Data updated 2026-11-12

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.

More Diffuse Large B Cell Lymphoma trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages14 Years and up
SexAll
Enrollment80 (estimated)
SponsorNavy General Hospital, Beijing
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedSeptember 24, 2024
Main results expectedDecember 2029
Study endsDecember 2030
Registry record updatedAugust 19, 2025
Trial IDNCT06664411 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.