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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 70 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | polatuzumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | October 24, 2023 |
| Main results expected | October 24, 2025 |
| Study ends | October 24, 2027 |
| Registry record updated | December 20, 2023 |
| Trial ID | NCT06176729 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or partial responses will continue with additional cycles, while those with stable or progressive disease will be withdrawn and offered alternative treatments.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
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Wei Wang, MD
- Email: wangweipumc@163.com
- Phone: +86 13810131294
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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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Combining pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin for elderly diffuse large B‑cell lymphoma
This tests whether adding polatuzumab vedotin to a pomalidomide, rituximab and orelabrutinib regimen helps patients aged 70 and older with newly diagnosed diffuse large B‑cell lymphoma.
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Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL
A group of elderly patients with newly diagnosed diffuse large B-cell lymphoma will try a lighter chemotherapy approach using three targeted drugs to see if it works and is safe.
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Pola‑R‑GemOx chemotherapy for relapsed/refractory DLBCL in patients who cannot have an autologous transplant
This trial will test whether adding polatuzumab vedotin to rituximab, gemcitabine, and oxaliplatin helps people with relapsed or refractory DLBCL who are not eligible for autologous stem‑cell transplant.
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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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Using stem cell transplant and Polatuzumab Vedotin for treating B-cell lymphomas
This study is testing if a stem cell transplant followed by a new drug called Polatuzumab Vedotin can help people with different types of B-cell lymphomas feel better.
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.