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

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Conditions

Large B-Cell Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-09-18
Study Completion:2030-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06047080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Previously untreated participants with CD20-positive LBCL
  2. * Ability to provide tumor tissue
  3. * International prognostic index (IPI) score 2-5
  4. * Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
  5. * At least one bi-dimensionally measurable lesion, defined as \> 1.5 cm in its longest dimension as measured by CT or MRI
  6. * Left ventricular ejection fraction (LVEF) \>/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
  7. * Adequate hematologic function
  8. * Negative HIV test at screening with exceptions as defined by the protocol
  9. * Negative SARS-CoV-2 antigen or PCR test
  1. * 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
  2. * Prior solid organ transplantation
  3. * 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
  4. * Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
  5. * History of indolent lymphoma (e.g., Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom macroglobulinemia)
  6. * 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
  7. * Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
  8. * Prior treatment with systemic immunotherapeutic agents
  9. * Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
  10. * Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
  11. * Prior radiotherapy to the mediastinal/pericardial region
  12. * Prior therapy for LBCL, with the exception of corticosteriods
  13. * Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
  14. * History of other malignant or non-malignant diseases that could affect compliance with the protocol or interpretation of results
  15. * Significant or extensive history of cardiovascular disease
  16. * Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
  17. * Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
  18. * Known or suspected chronic active Epstein-Barr viral infection
  19. * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  20. * Active autoimmune disease requiring treatment
  21. * Clinically significant liver disease
  22. * 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
  23. * Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
  24. * Suspected active or latent tuberculosis
  25. * Positive test results for chronic hepatitis B infection, hepatitis C, or the human T-lymphotropic virus type 1 (HTLV-1)
  26. * History of progressive multifocal leukoencephalopathy

Contacts and Locations

Principal Investigator

Clinical Trials
STUDY_DIRECTOR
Hoffmann-La Roche

Study Locations (Sites)

Alaska Oncology & Hematology, LLC
Anchorage, Alaska, 99508
United States
Kaiser Permanente - Anaheim (E. La Palma)
Anaheim, California, 92806
United States
University of California, San Francisco-Fresno
Clovis, California, 93611
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
City of Hope - Lennar Foundation Cancer Center
Irvine, California, 92618
United States
Valkyrie Clinical Trials
Los Angeles, California, 90067
United States
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
United States
Kaiser Permanente - Roseville
Roseville, California, 95661
United States
Kaiser Permanente - Santa Clara
Santa Clara, California, 95051
United States
Stanford Univ School of Med
Stanford, California, 94305-5821
United States
Kaiser Permanente Medical Ctr
Vallejo, California, 94589
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Rocky Mountain Cancer Center - Denver
Littleton, Colorado, 80120
United States
Yale University School Of Medicine
New Haven, Connecticut, 06519
United States
Medstar Franklin Square Medical Center
Washington D.C., District of Columbia, 20010
United States
Miami Cancer Institute of Baptist Health, Inc.
Miami, Florida, 33176
United States
Memorial Cancer Institute at Memorial West
Pembroke Pines, Florida, 33028
United States
Hawaii Cancer Care
Honolulu, Hawaii, 96813
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60637-1447
United States
Illinois Cancer Care
Peoria, Illinois, 61615
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Ascension Via Christi Research
Wichita, Kansas, 67214
United States
Ochsner Medical Center
New Orleans, Louisiana, 70121
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Boston Medical Center
Boston, Massachusetts, 02218
United States
Henry Ford Health System
Novi, Michigan, 48377-3600
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
United States
St. Luke's Hospital
Chesterfield, Missouri, 63017
United States
Washington University School of Medicine
St Louis, Missouri, 63110
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-0600
United States
NYU Langone Hospital?Brooklyn
Brooklyn, New York, 11220
United States
NYU Long Island Hospital
Mineola, New York, 11501
United States
New York University Medical Center PRIME
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care
New York, New York, 10021
United States
Weill Cornell Medical College-New York Presbyterian Hospital
New York, New York, 10021
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
North Shore Hematology Oncology Association PC
Shirley, New York, 11967
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
New York Cancer & Blood Specialists
The Bronx, New York, 10469
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
Willamette Valley Cancer Insitute and Research Center
Springfield, Oregon, 97477
United States
Kimmel Cancer Center Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
United States
Greco-Hainesworth Tennessee Oncology Centers for Research
Chattanooga, Tennessee, 37404
United States
West Cancer Center & Research Institute
Germantown, Tennessee, 38138
United States
Tennessee Oncology
Nashville, Tennessee, 37203
United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
United States
USOR - Texas Oncology - San Antonio Northeast
San Antonio, Texas, 78217
United States
University of Vermont
Burlington, Vermont, 05401
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Virginia Oncology Associates
Newport News, Virginia, 23606
United States
Swedish Medical Center
Seattle, Washington, 98104-1360
United States
University of Washington - Seattle Cancer Care Alliance
Seattle, Washington, 98109
United States
West Virginia University
Morgantown, West Virginia, 26506
United States
Univ of Wisconsin Hosp & Clin
Madison, Wisconsin, 53792
United States

Collaborators and Investigators

Sponsor: Hoffmann-La Roche

  • Clinical Trials, STUDY_DIRECTOR, Hoffmann-La Roche

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-18
Study Completion Date2030-12-31

Study Record Updates

Study Start Date2023-09-18
Study Completion Date2030-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Large B-Cell Lymphoma