Home › Trials › NCT06047080

Comparing two treatments for previously untreated large B-cell lymphoma

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

Phase 3 Interventional Hoffmann-La Roche · NCT06047080

This study is testing a new combination of treatments for people with previously untreated large B-cell lymphoma to see if it works better and has fewer side effects than the standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1130 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsglofitamab, methotrexate, prednisone, polatuzumab, rituximab, cyclophosphamide, doxorubicin
Locations268 sites (Anchorage, Alaska and 267 other locations)
Trial IDNCT06047080 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness and safety of glofitamab combined with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone against the standard Pola-R-CHP regimen in patients with previously untreated CD20-positive large B-cell lymphoma. Participants must have measurable lesions and meet specific health criteria. The study will assess how well these treatments work in managing the disease and their associated side effects.

Who should consider this trial

Good fit: Ideal candidates are previously untreated individuals with CD20-positive large B-cell lymphoma who meet the study's health criteria.

Not a fit: Patients with contraindications to the study drugs or prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with large B-cell lymphoma.

How similar studies have performed: Other studies have shown promising results with similar treatment combinations, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Anchorage, Alaska and 267 other locations

+218 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Large B-Cell Lymphoma
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.