Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
NCT Number: NCT06176729
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).
Interested in participating?
Request Info70 year and older
All sexes
Interventional
Phase 2
Beijing, Beijing Municipality, 100730, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
polatuzumab vedotin 1.8 mg/kg ivgtt D1, rituximab375 mg/m2 ivgtt D1, lenalidomide 25mg po D1-14, one cycle every 21 days
Time frame: evaluated every 3 months,up to 24 months
proportion of patients achieving complete remission
Time frame: evaluated every 3 months,up to 24 months
proportion of patients achieving at least partial remission
Time frame: 2 years after last patient included
time from treatment to the time of disease progression or death of any reason
Time frame: 2 years after last patient included
time from treatment to the time of death of any reason
Time frame: 2 years after last patient included
safety
Contact information is provided by the study sponsor or research team.
Wei Wang, MD
CONTACT
Zhaohui Zhu, MD
CONTACT
Yan Zhang, MD
Other
A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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