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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGcomplete remission rate
proportion of patients achieving complete remission
Time frame: evaluated every 3 months,up to 24 months
overall remission rate
proportion of patients achieving at least partial remission
Time frame: 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
Time frame: 2 years after last patient included
2 year overall survival rate
time from treatment to the time of death of any reason
Time frame: 2 years after last patient included
any adverse event occurred during this study
safety
Time frame: 2 years after last patient included
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