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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

NCT05798156 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-04-08

No results posted yet for this study

Summary

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.

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Interventions

DRUG

Glofitamab

Glofitamab is a fully humanized, engineered monoclonal bivalent antibody of the IgG1 isotype.

DRUG

Rituximab

Rituximab is a genetically engineered chimeric mouse/human anti-CD20 monoclonal antibody

DRUG

Obinutuzumab

Obinutuzumab is a fully humanized, glycoengineered type II monoclonal antibody of the IgG1 isotype that binds to an epitope on CD20

DRUG

Polatuzumab vedotin

Polatuzumab vedotin is an antibody-drug-conjugate that contains a humanized IgG1 anti-CD79b monoclonal antibody (MCDS4409A) and a potent anti-mitotic agent (MMAE) linked through a protease-cleavable linker.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University of Salzburg

    collaborator OTHER

  • Arbeitsgemeinschaft medikamentoese Tumortherapie

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • Zentrum für Klinische Studien Leipzig

    collaborator OTHER

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Salah-Eddin Al-Batran, Prof. Dr. · Institut fuer Klinische Krebsforschung IKF GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
61 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2025-04-12
Completion
2028-02-28

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05798156 on ClinicalTrials.gov