A study exploring the safety and efficacy of Atezolizumab in combination with Obinutuzumab or Rituximab anti-CD20 therapy in participants with Relapse/Refractory Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL) and Waldenström Macrobulinemia (WM)

  • Cancer
Trial Status:

Active, not recruiting

This trial runs in
Countries
  • Bosnia and Herzegovina
  • France
  • Germany
  • Greece
  • Italy
  • Korea, Republic of
  • Latvia
  • Russian Federation
  • Slovakia
  • Spain
  • Switzerland
Trial Identifier:

2016-003579-22 MO39107

      Show trial locations

      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.

      Results Disclaimer

      Trial Summary

      Atezolizumab + Rituximab in R/R MZL and Atezolizumab + Obinutuzumab in R/R MCL and WM

      F. Hoffman La Roche (Switzerland) Sponsor
      Phase 2 Phase
      MO39107 , 2016-003579-22 Trial Identifier
      Male/Female Gender
      >= 18 Years Age
      No Healthy Volunteers

      This study is a multicenter, open-label, phase 2 study of atezolizumab (A) in combination with rituximab (R) or Obinituzumab (G), all administered by intravenous infusion (IV) in participants with refractory and/or relapsed Marginal Zone Lymphoma and Waldenström Macroglobulinemia or Mantle Cell Lymphoma. This study will evaluate the safety and efficacy of the above combinations as well as pharmacokinetic parameters, biomarkers and occurrence of anti-drug antibodies of A, R and G.

      Trial Summary

      Atezolizumab + Rituximab in R/R MZL and Atezolizumab + Obinutuzumab in R/R MCL and WM

      F. Hoffman La Roche (Switzerland) Sponsor
      Phase 2 Phase
      MO39107 , 2016-003579-22 Trial Identifier
      atezolizumab, obinutuzumab, rituximab Treatments
      Relapsed/Refractory Mantle Cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) and Waldenström Macroglobulinemia (WM) Condition
      Official Title

      A Phase II study exploring the safety and efficacy of atezolizumab administered in combination with obinutuzumab or rituximab anti-cd20 therapy in patients with relapsed/refractory mantle cell lymphoma, marginal zone lymphoma and waldenström macroglobulinemia

      Eligibility Criteria

      Male/Female Gender
      >= 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria

      Histologically documented, CD20 positive non-Hodgkin lymphoma (NHL), relapsed or refractory MCL and MZL. For WM relapse/refractory intended as reappearance of monoclonal IgM protein and/or recurrence of bone marrow involvement, lymphadenopathy/splenomegaly or symptoms attributable to active disease Patients must have failed at least 1 prior line of systemic treatment for mucosa associated lymphoid tissue patients.

      • Bone marrow biopsy and/or other sites of disease at screening for tumor staging and response evaluation
      • ECOG performance status of 0, 1 or 2
      • Life expectancy>=12 weeks
      Exclusion Criteria
      • Any approved anticancer therapy or hormonal therapy within 3 weeks prior to initiation of study treatment. Any radiotherapy within 4 weeks prior to initiation of study treatment.
      • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days or 5 half-lifes prior to enrolment, whichever is longest.
      • Known Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma
      • Uncontrolled tumor-related pain
      • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures; patients with indwelling catheters are eligible
      • Uncontrolled hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
      • History of other malignancy
      • History of severe allergic or anaphylactic or other hypersensitivity reactions to chimeric or humanized or murine monoclonal antibodies or fusion proteins or murine proteins or known sensitivity or allergy to murine products

      Clinical Research Explained

      Information about what clinical trials and observational studies are. Understand why you might want to take part in clinical research and why diversity in clinical research is important.

      Find out now