Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients
- Sponsor
- Yan Zhang, MD
- Study ID
- NCT06176729
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Diffuse Large B Cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 70 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Polatuzumab Vedotin, Rituximab, Lenalidomide — DRUGpolatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days
Study Details
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).
Key Dates
- Start date
- Oct 24, 2023
- Status verified
- Dec 2023
- Primary completion
- Oct 24, 2025
- Completion
- Oct 24, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Experimental armPola-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
Primary Outcome Measure
complete remission rate [ Time Frame: evaluated every 3 months,up to 24 months ]
Central Contacts
- Wei Wang, MD+86 13810131294
- Zhaohui Zhu, MD+861069156874
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