A Phase 2 interventional study of Polatuzumab Vedotin, Rituximab, Lenalidomide in Diffuse Large B Cell Lymphoma, sponsored by Yan Zhang, MD. Recruiting at 1 site in China. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-12-20.
Sponsored by Yan Zhang, MD · Phase 2, Interventional, and Treatment
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.
1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.
This study's planned enrollment of 30 is below the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.
Browse Lymphoma, Large B-Cell, Diffuse studies →This is the only study on the registry with Yan Zhang, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days
complete 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
Plan to share: No
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Lymphoma, Large B-Cell, Diffuse→