Pola-R2 in Newly Diagnosed Non-fit Elderly DLBCL Patients

Phase 2

Recruiting

• Conditions: Diffuse Large B Cell Lymphoma
• Interventions: Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide

• Registration Number: NCT06176729
• Lead Sponsor: Yan Zhang, MD

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 classified into un-fit or frail group by comprehensive geriatric assessment(CGA).

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 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 Timeline

• Study Start: 2023-10-24
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Study First Posted: 2023-12-20
• Last Update Posted: 2023-12-20
• Primary Completion: 2025-10-24
• Study Completion: 2027-10-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Polatuzumab Vedotin, Rituximab, Lenalidomide	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

Primary Outcome Measures

Name	Time	Method
complete remission rate	evaluated every 3 months，up to 24 months	proportion of patients achieving complete remission

Secondary Outcome Measures

Name	Time	Method
overall remission rate	evaluated every 3 months，up to 24 months	proportion of patients achieving at least partial remission
2 year progression-free survival rate	2 years after last patient included	time from treatment to the time of disease progression or death of any reason
2 year overall survival rate	2 years after last patient included	time from treatment to the time of death of any reason
any adverse event occurred during this study	2 years after last patient included	safety

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China