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RecruitingLast updated: 28 March 2024

SkyGLO: This study is comparing how safe and effective adding a targeted therapy called glofitamab to a treatment regimen called Pola-R-CHP (which includes targeted therapy, chemotherapy and steroids) is in people with previously untreated CD20-positive large B-Cell lymphomaA 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

Clinical summary

Summary

Eligible participants will be randomly allocated to one of two treatment arms.

In Arm A (Experimental), participants will receive glofitamab in combination with Pola-R-CHP (which consists of polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone).

In Arm B (Active Comparator), participants will receive Pola-R-CHP.

Conditions

This trial is treating patients with CD20-positive large B-cell lymphoma

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

SkyGLO

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific 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

Eligibility

Inclusion

  • Previously untreated participants with CD20-positive LBCL
  • Confirmed availability of 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
  • Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
  • History of indolent lymphoma
  • 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; primary effusion DLBCL; and primary cutaneous DLBCL
  • 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
  • History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents
  • 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

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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