Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Large B-Cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2030
Estimated Enrollment :
1130 Patients enrolled
Trial Details
Trial ID
NCT06047080
Start Date
September 18 2023
End Date
December 31 2030
Last Update
December 18 2025
Active Locations (231)
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1
Alaska Oncology & Hematology, LLC
Anchorage, Alaska, United States, 99508
2
Kaiser Permanente - Anaheim (E. La Palma)
Anaheim, California, United States, 92806
3
University of California, San Francisco-Fresno
Clovis, California, United States, 93611
4
City of Hope National Medical Center
Duarte, California, United States, 91010