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

A Prospective Phase II Study of Polatuzumab, Rituximab, and Lenalidomide(Pola-R2) in Newly-diagnosed Non-fit Elderly DLBCL Patients

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).

Study Overview

• Status: Recruiting
• Conditions: Diffuse Large B Cell Lymphoma
• Intervention / Treatment: Drug: Polatuzumab Vedotin, Rituximab, Lenalidomide

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Wang, MD; Phone Number: +86 13810131294; Email: wangweipumc@163.com
• Study Contact Backup: Name: Zhaohui Zhu, MD; Phone Number: +861069156874; Email: pumchkyc@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Wei Wang, MD; Phone Number: +8613810131294; Email: wangweipumc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete remission rate	proportion of patients achieving complete remission	evaluated every 3 months，up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall remission rate	proportion of patients achieving at least partial remission	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	2 years after last patient included
2 year overall survival rate	time from treatment to the time of death of any reason	2 years after last patient included
any adverse event occurred during this study	safety	2 years after last patient included

Collaborators and Investigators

• Sponsor: Yan Zhang, MD
• Collaborators: Peking University First Hospital; Chinese PLA General Hospital; Peking University Third Hospital
• Investigators: Study Chair: Yan Zhang, MD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2023
• Primary Completion (Estimated): October 24, 2025
• Study Completion (Estimated): October 24, 2027

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 19, 2023
• First Posted (Estimated): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Immunoconjugates; Lenalidomide; Rituximab; Polatuzumab vedotin
• Other Study ID Numbers: 2022-PUMCH-A-194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No