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Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP

Study acronym: R-Pola-Glo
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study sites: 30 to 28
    • Study completion date: Sep 30, 2028 to Feb 28, 2028
    v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Apr 30, 2025 to Apr 12, 2025
    • Site details revised at 30 of 30 sites
    v6
  3. Trial status: Active, Not Recruiting to Recruitingv5 Show 5 more changesShow less
    • Enrollment target: 80 to 125
    • Primary completion date: Sep 30, 2027 to Apr 30, 2025
    • Primary endpoint revised
    • Study sites: 24 to 30
    • Eligibility criteria shortened, about 17 words
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 24 of 24 sites
    v4
  5. Study sites: 18 to 24
    • Study title shortened, about 1 word
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 31, 2023 to Mar 20, 2023
    • Eligibility criteria expanded, about 91 words
    • Site details revised at 18 of 18 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
In the present trial the chemotherapy- light treatment concept R-Pola-Glo will be evaluated that combines the anti-CD20 antibody rituximab (R) with the ADC polatuzumab vedotin (Pola) and the (BiMabs) glofitamab (Glo) in elderly and/or medical unfit and previously untreated patients with aggressive B-cell lymphoma. The outcome and feasibility data obtained here will be used for further clinical development of this new chemolight triple combination.
Trial Details
NCT Number NCT05798156
Lead Sponsor Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Collaborators: Charite University, Berlin, Germany, University of Salzburg, Arbeitsgemeinschaft medikamentoese Tumortherapie, Roche Pharma AG, Zentrum für Klinische Studien Leipzig, Hoffmann-La Roche
Conditions
(from sponsor)		 Lymphoma, Large B-Cell, Diffuse
Related terms Lymphoma, Large B-Cell, Diffuse
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov