Treatment for elderly patients with newly diagnosed diffuse large B cell lymphoma
A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients
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 |
| Enrollment | 30 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Drugs / interventions | polatuzumab |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06176729 on ClinicalTrials.gov |
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or partial responses will continue with additional cycles, while those with stable or progressive disease will be withdrawn and offered alternative treatments.
Who should consider this trial
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.
Not a fit: Patients with coexisting malignancies, active infections, or significant systemic disease may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Wei Wang, MD
- Email: wangweipumc@163.com
- Phone: +86 13810131294
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.