Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients

Study Overview
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Brief Summary
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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).

Detailed Description
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In this prospective study, all the eligible patients will be given Pola-R2 regimen(polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days). An interim evaluation will be performed after 4 cycles, the patients who achieve CR or PR will receive another 4 cycles of Pola-R2. The patients with stable disease (SD) or progressed disease (PD) will withdraw from the trial and receive salvage regimens.

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

Conditions
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Diffuse Large B Cell Lymphoma

Intervention / Treatment
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* Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br>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 | Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide<br>* polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission rate | proportion of patients achieving complete remission | evaluated every 3 months，up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall remission rate | proportion of patients achieving at least partial remission | evaluated every 3 months，up to 24 months | 
| 2 year progression-free survival rate | time from treatment to the time of disease progression or death of any reason | 2 years after last patient included | 
| 2 year overall survival rate | time from treatment to the time of death of any reason | 2 years after last patient included | 
| any adverse event occurred during this study | safety | 2 years after last patient included |