A Phase III, Multicenter, Randomized, Open Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) In Combination with Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, And Prednisone (Pola-R-Chp) Versus Pola R Chp in Previously Untreated Patients with Large B-Cell Lymphoma

Cancer Categories

Hematologic (Blood Cancers)

Karmanos Trial ID

2024-014

NCT ID

NCT06047080

Age Group

Adult

Scope

National

Phase

Phase III

Principal Investigator

Dipenkumar
Modi, M.D.
Oncology - Hematology, Oncology - Medical View Profile

Objective:

Primary Objective:

To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP

Secondary Objectives:

To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP
To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP in patients with IPI 3-5
To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP in
participants classified to be high-risk based on ctDNA
To evaluate the safety of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP
To characterize the glofitamab PK profile in combination with Pola-RCHP
To evaluate the immunogenicity of glofitamab in combination with Pola-R-CHP
To evaluate the health-related quality of life (HRQoL) of participants treated with glofitamab in
combination with Pola-R-CHP

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Eligibility

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 > 50 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
History of other malignancy 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 which is not well controlled by therapy
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)

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Farmington Hills, MI 48334
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