Clinical trial · Interventional
Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients
A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients
NCT06176729CI-TRIAL-00072433recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective, single-arm, phase II study, and the purpose of this study is to evaluate the efficacy and safety of Pola-R2 regimen in newly diagnosed elderly diffuse large B cell lymphoma classified into un-fit or frail group by comprehensive geriatric assessment(CGA).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Polatuzumab Vedotin, Rituximab, Lenalidomide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Pola-R2 regimen Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days
- interventionNames
- Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide
Primary outcomes (1)
- measure
- complete remission rate
- timeFrame
- evaluated every 3 months，up to 24 months
- description
- proportion of patients achieving complete remission
Secondary outcomes (4)
- measure
- overall remission rate
- timeFrame
- evaluated every 3 months，up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.