Menu
Recruiting NCT06176729

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

Phase II Interventional Diffuse Large B Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Polatuzumab Vedotin, Rituximab, Lenalidomide.
Who it may be relevant to
Registry conditions: Diffuse Large B Cell Lymphoma. Basic parameters: from 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

  • complete remission rate [Time frame: evaluated every 3 months，up to 24 months]
Secondary outcome measures (4)
  • overall remission rate [Time frame: evaluated every 3 months，up to 24 months]
  • 2 year progression-free survival rate [Time frame: 2 years after last patient included]
  • 2 year overall survival rate [Time frame: 2 years after last patient included]
  • any adverse event occurred during this study [Time frame: 2 years after last patient included]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT06176729 · 2022-PUMCH-A-194

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗