Trials / Active Not Recruiting
Active Not RecruitingNCT05798156
Rituximab in Combination With Glofitamab and Polatuzumab Vedotin in Patients With Previously Untreated Aggressive B-cell Lymphoma Ineligible for R-CHOP
A Prospective Multicenter Phase 2 Study of the Chemotherapy-light Combination of Intravenous Rituximab With the Antibody-drug Conjugate Polatuzumab Vedotin and the Bispecific Antibody Glofitamab in Previously Untreated Aggressive B-cell Lymphoma Patients Above 60 Years of Age Ineligible for a Fully Dosed R-CHOP
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
- Sex
- All
- Age
- 61 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-03-20
- Primary completion
- 2025-04-12
- Completion
- 2028-02-28
- First posted
- 2023-04-04
- Last updated
- 2026-04-08
Locations
28 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT05798156. Inclusion in this directory is not an endorsement.