Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 70 and up

Treatment for elderly patients with newly diagnosed diffuse large B cell lymphoma

Official title: A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients

Run by Peking Union Medical College Hospital · NCT06176729 · Data updated 2026-11-12

This study is testing a new combination treatment for older patients with newly diagnosed diffuse large B cell lymphoma to see if it helps them respond better to therapy.

Quick facts

PhasePhase 2
Study typeInterventional
Ages70 Years and up
SexAll
Enrollment30 (estimated)
SponsorPeking Union Medical College Hospital
Academic / other
Drugs / interventionspolatuzumab
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedOctober 24, 2023
Main results expectedOctober 24, 2025
Study endsOctober 24, 2027
Registry record updatedDecember 20, 2023
Trial IDNCT06176729 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are elderly individuals aged 70 and older with newly diagnosed diffuse large B cell lymphoma who are classified as un-fit or frail.

Probably not a fit

Patients with coexisting malignancies, active infections, or significant systemic disease 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 evaluates the efficacy and safety of the Pola-R2 regimen, which includes polatuzumab vedotin, rituximab, and lenalidomide, in elderly patients aged 70 and older who are newly diagnosed with diffuse large B cell lymphoma and classified as un-fit or frail. Eligible participants will receive the treatment in cycles, with an interim evaluation after four cycles to assess their response. Patients achieving complete or partial responses will continue with additional cycles, while those with stable or progressive disease will be withdrawn and offered alternative treatments.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for elderly patients with a challenging form of lymphoma.

How similar studies have gone: Other studies have shown promise in treating elderly patients with diffuse large B cell lymphoma using similar regimens, but this specific approach is being evaluated for the first time in this population.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* The patient volunteered to participate in the study and signed the Informed Consent
* Histopathologically confirmed DLBCL and treatment naive(corticosteroids alone is not considered as a line of treatment)
* Age≥ 70 years old, and was un-fit or frail according to comprehensive geriatric assessment
* Adequate organ function and adequate bone marrow reserve

Exclusion Criteria:

* Coexisting malignancy other than lymphoma
* Active HBV infection
* Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy

Where it's running

  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

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.