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

December 19, 2023 updated by: Yan Zhang, MD

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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