Status:
RECRUITING
Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients
Lead Sponsor:
Yan Zhang, MD
Collaborating Sponsors:
Peking University Third Hospital
Peking University First Hospital
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief 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 clas...
Detailed Description
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 d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 24 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06176729
Start Date
October 24 2023
End Date
October 24 2027
Last Update
December 20 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730