A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

  • Diffuse Large B-Cell Lymphoma
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • South Korea
  • Spain
  • Turkey
  • United Kingdom
  • United States
Trial Identifier:

NCT02257567 2014-001361-28 GO29365

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT02257567 , GO29365 , 2014-001361-28 Trial Identifier
      Bendamustine, Obinutuzumab, Polatuzumab vedotin (Liquid), Rituximab, Polatuzumab vedotin (Lyophilized) Treatments
      Lymphoma Condition
      Official Title

      A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Histologically confirmed relapsed or refractory FL (Grades 1, 2, or 3a) or relapsed or refractory DLBCL
      • If the participant has received prior bendamustine, response duration must have been greater than (>) 1 year (for participants who have relapse disease after a prior regimen)
      • At least one bi-dimensionally measurable lesion on imaging scan defined as >1.5 centimeters (cm) in its longest dimension
      • Confirmed availability of archival or freshly collected tumor tissue
      • The Phase II NF Cohorts (Arms G and H) will be required to submit tissue and pathology report for central pathology review.
      • Life expectancy of at least 24 weeks
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
      • Adequate hematological function unless inadequate function is due to underlying disease
      Exclusion Criteria
      • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs, or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
      • Contraindication to bendamustine, rituximab, or obinutuzumab
      • Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before Cycle 1 Day 1
      • Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
      • Ongoing corticosteroid use >30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control
      • Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1 Day 1
      • Prior allogeneic SCT
      • Eligibility for autologous SCT
      • Grade 3b FL
      • History of transformation of indolent disease to DLBCL
      • Primary or secondary CNS lymphoma
      • Current Grade >1 peripheral neuropathy
      • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
      • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1 Day 1
      • Suspected or latent tuberculosis
      • Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C virus (HCV) antibody
      • Known history of human immunodeficiency virus (HIV) seropositive status or known infection with human T-cell leukemia virus 1 (HTLV-1) virus
      • Women who are pregnant or lactating or who intend to become pregnant within a year of the last dose of study treatment in the rituximab cohort or within 18 months of last dose in the obinutuzumab cohort
      • Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation function tests
      • Treatment with chimeric antigen receptor T-cell therapy within 100 days prior to Cycle 1, Day 1

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