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

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT05798156
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
61 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    Glofitamab is a fully humanized, engineered monoclonal bivalent antibody of the IgG1 isotype.
  • Rituximab — DRUG
    Rituximab is a genetically engineered chimeric mouse/human anti-CD20 monoclonal antibody
  • Obinutuzumab — DRUG
    Obinutuzumab is a fully humanized, glycoengineered type II monoclonal antibody of the IgG1 isotype that binds to an epitope on CD20
  • Polatuzumab vedotin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 20, 2023
Status verified
Apr 2026
Primary completion
Apr 12, 2025
Completion
Feb 28, 2028

Study Design

Enrollment
125 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: chemolight R-Pola-Glo treatment

Primary Outcome Measure

1 year progression-free survival (PFS) rate of the first 80 patients [ Time Frame: 12 months ]

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