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NCT04332822 · ClinicalTrials.gov record · last posted 2024-09-19

A Randomized, Multicenter, Phase III Trial Comparing Treatment With R-mini-CHOP With R-mini-CHP + Polatuzumab Vedotin in Patients With Diffuse Large Cell B Cell Lymphoma

Study acronym: POLAR BEAR
StatusRecruiting
PhasePhase 3
Started2020-08-19
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 19, 2024 (before its estimated December 28, 2025 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
This is a phase III, randomized, open-label, multicenter trial, conducted in Sweden, Norway, Finland, Denmark, Italy, Australia and New Zealand, in elderly patients with untreated diffuse large B-cell lymphoma. Elderly is defined as either ≥80 years of age, or ≥75 years and frail, according to a simplified Comprehensive Geriatric Assessment. Patients will be randomized 1:1 to either the standard treatment for this population, R-miniCHOP, or an experimental regimen, R-pola-miniCHP, where vincristine is substituted by an immunoconjugate, polatuzumab vedotin. The duration of the screening period is up to 4 weeks. The duration of active treatment is 18 weeks in both arms, and patients will be followed up to 36 months after end of treatment. Start of enrollment is planned in Q1 2020, and the last visit of the last patient included (end of trial) is estimated in Q1 2027.

Amendment record 7 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 7 times since 2020-04-01; most recent amendment 2024-09-10. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2020-09-09
Status change Not Yet Recruiting→Recruitingv2
Trial Details
NCT Number NCT04332822
Lead Sponsor Nordic Lymphoma Group
Collaborators: Roche Pharma AG
Conditions DLBCL, Diffuse Large B Cell Lymphoma
Enrollment 300 participants
Start Date 2020-08-19
Primary Completion 2025-12-28 (estimated)
Study Completion 2028-12-28 (estimated)
Updated on ClinicalTrials.gov 2024-09-19