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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

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ClinicalTrials.gov Identifier: NCT06047080
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : May 8, 2024
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE September 14, 2023
First Posted Date  ICMJE September 21, 2023
Last Update Posted Date May 8, 2024
Actual Study Start Date  ICMJE September 18, 2023
Estimated Primary Completion Date June 1, 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2023)
Progression-free survival (PFS) as determined by Independent Review Facility (IRF) [ Time Frame: From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2023)
  • PFS as determined by the investigator [ Time Frame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 65 months) ]
  • PFS as determined by the investigator and IRF for participants with international prognostic index (IPI) 3-5 [ Time Frame: From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to 65 months) ]
  • Event-free survival efficacy causes (EFSeff) [ Time Frame: From randomization to the earliest occurrence of disease progression or relapse; death due to any cause; initiation of new anti-lymphoma treatment; or positive biopsy for residual disease after treatment completion (up to approximately 65 months) ]
  • Complete response (CR) rate [ Time Frame: At the end of treatment (up to approximately 65 months) ]
  • Objective response rate (ORR) [ Time Frame: At treatment completion or discontinuation (up to approximately 65 months) ]
  • Overall survival (OS) [ Time Frame: From randomization to death from any cause (up to approximately 65 months) ]
  • Duration of response (DOR) [ Time Frame: From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 65 months) ]
  • Duration of complete response (DOCR) [ Time Frame: From the first occurrence of a documented complete response (CR) to disease progression or death, whichever occurs first (up to approximately 65 months) ]
  • Disease-free survival (DFS) [ Time Frame: From a documented CR at the end of treatment to disease progression or death, whichever occurs first (up to approximately 65 months) ]
  • Serum concentration of glofitamab [ Time Frame: Up to approximately 65 months ]
  • Incidence of anti-drug antibodies (ADAs) [ Time Frame: Baseline up to approximately 65 months ]
  • Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS) [ Time Frame: Up to approximately 65 months ]
  • Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS) [ Time Frame: Up to approximately 65 months ]
  • Percentage of Participants with Adverse Events (AEs) [ Time Frame: From randomization to the end of study (up to approximately 65 months) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Large B-Cell Lymphoma
Intervention  ICMJE
  • Drug: Glofitamab
    Participants will receive intravenous (IV) glofitamab
  • Drug: Polatuzumab vedotin
    Participants will receive IV polatuzumab vedotin in combination with R-CHP
  • Drug: Rituximab
    Participants will receive IV rituximab
  • Drug: Cyclophosphamide
    Participants will receive cyclophosphamide as part of CHP chemotherapy
  • Drug: Doxorubicin
    Participants will receive IV doxorubicin
  • Drug: Prednisone
    Participants will receive oral prednisone as part of CHP chemotherapy
Study Arms  ICMJE
  • Experimental: Glofitamab + Pola-R-CHP
    Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).
    Interventions:
    • Drug: Glofitamab
    • Drug: Polatuzumab vedotin
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Prednisone
  • Active Comparator: Pola-R-CHP
    Participants will receive Pola-R-CHP.
    Interventions:
    • Drug: Polatuzumab vedotin
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: Doxorubicin
    • Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2023)
1130
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2029
Estimated Primary Completion Date June 1, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
  • History of progressive multifocal leukoencephalopathy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Reference Study ID Number: GO44145 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Denmark,   France,   Germany,   Italy,   Japan,   Korea, Republic of,   Mexico,   Poland,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06047080
Other Study ID Numbers  ICMJE GO44145
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP