A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Wei Wang, MD
wangweipumc@163.com
+86 13810131294
Backup
Zhaohui Zhu, MD
pumchkyc@126.com
+861069156874
Time Frame
Start Date: 2023-10-24
Estimated Completion Date: 2027-10-24
Participants
Target number of participants: 30
Treatments
Experimental: Experimental arm
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
Related Therapeutic Areas
Sponsors
Leads: Yan Zhang, MD
Collaborators: Peking University First Hospital, Peking University Third Hospital, Chinese PLA General Hospital