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Clinical Trials in Germany / NCT06047080
Active, not recruiting Phase 3

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

NCT06047080 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2023-09-18
Last updated
2026-09-11

Condition(s) studied

Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

Glofitamab →Polatuzumab vedotin →Rituximab →Cyclophosphamide →Doxorubicin →Prednisone →

Glofitamab: Participants will receive intravenous (IV) glofitamab

Polatuzumab vedotin: Participants will receive IV polatuzumab vedotin in combination with R-CHP

Rituximab: Participants will receive IV rituximab

Cyclophosphamide: Participants will receive cyclophosphamide as part of CHP chemotherapy

Doxorubicin: Participants will receive IV doxorubicin

Prednisone: Participants will receive oral prednisone as part of CHP chemotherapy

Study summary

The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Previously untreated participants with CD20-positive LBCL * Ability to provide tumor tissue * International prognostic index (IPI) score 2-5 * Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2 * At least one bi-dimensionally measurable lesion, defined as \> 1.5 cm in its longest dimension as measured by CT or MRI * Left ventricular ejection fraction (LVEF) \>/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) * Adequate hematologic function * Negative HIV test at screening with exceptions as defined by the protocol * Negative SARS-CoV-2 antigen or PCR test Exclusion Criteria: * Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products * Prior solid organ transplantation * Participants receiving systemic immunosuppressive agent such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 4 weeks prior to first dose of study treatment * Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease * History of indolent lymphoma (e.g., Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom macroglobulinemia) * Current diagnosis of the following: Follicular lymphoma grade 3B; transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma); mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; primary large B-cell lymphoma of immune-privileged sites (encompassing primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina and primary large B-cell lymphoma of the testis); primary effusion DLBCL; and primary cutaneous DLBCL, leg type * Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma * Prior treatment with systemic immunotherapeutic agents * Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1 * Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1 * Prior radiotherapy to the mediastinal/pericardial region * Prior therapy for LBCL, with the exception of corticosteriods * Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control * History of other malignant or non-malignant diseases that could affect compliance with the protocol or interpretation of results * Significant or extensive history of cardiovascular disease * Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis * Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Known or suspected chronic active Epstein-Barr viral infection * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Active autoimmune disease requiring treatment * Clinically significant liver disease * Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover are prohibited * Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety * Suspected active or latent tuberculosis * Positive test results for chronic hepatitis B infection, hepatitis C, or the human T-lymphotropic virus type 1 (HTLV-1) * History of progressive multifocal leukoencephalopathy

Primary outcome measure(s)

Trial sites (229)

FacilityCityRegionStatus
Alaska Oncology & Hematology, LLC Anchorage Alaska
Kaiser Permanente - Anaheim (E. La Palma) Anaheim California
University of California, San Francisco-Fresno Clovis California
City of Hope National Medical Center Duarte California
City of Hope - Lennar Foundation Cancer Center Irvine California
Valkyrie Clinical Trials Los Angeles California
UCLA Jonsson Comprehensive Cancer Center Los Angeles California
Kaiser Permanente - Roseville Roseville California
Kaiser Permanente - Santa Clara Santa Clara California
Stanford Univ School of Med Stanford California
Kaiser Permanente Medical Ctr Vallejo California
University of Colorado Cancer Center Aurora Colorado
Rocky Mountain Cancer Center - Denver Littleton Colorado
Yale University School Of Medicine New Haven Connecticut
Medstar Franklin Square Medical Center Washington D.C. District of Columbia
Miami Cancer Institute of Baptist Health, Inc. Miami Florida
Memorial Cancer Institute at Memorial West Pembroke Pines Florida
Hawaii Cancer Care Honolulu Hawaii
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Chicago Illinois
Illinois Cancer Care Peoria Illinois
Springfield Clinic Springfield Illinois
University of Iowa Iowa City Iowa
Ascension Via Christi Research Wichita Kansas
Ochsner Medical Center New Orleans Louisiana
Massachusetts General Hospital Boston Massachusetts
Dana Farber Cancer Institute Boston Massachusetts
Boston Medical Center Boston Massachusetts
Henry Ford Health System Novi Michigan
M Health Fairview University of Minnesota Medical Center Minneapolis Minnesota
St. Luke's Hospital Chesterfield Missouri
Washington University School of Medicine St Louis Missouri
University of Nebraska Medical Center Omaha Nebraska
NYU Langone Hospital?Brooklyn Brooklyn New York
NYU Long Island Hospital Mineola New York
New York University Medical Center PRIME New York New York
Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care New York New York
Weill Cornell Medical College-New York Presbyterian Hospital New York New York
University of Rochester Medical Center Rochester New York
North Shore Hematology Oncology Association PC Shirley New York
Montefiore Medical Center The Bronx New York

+ 189 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

More Hoffmann-La Roche trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06047080 on ClinicalTrials.gov ↗ ← All trials in Germany