A Study of Idasanutlin in Combination With Obinutuzumab in Relapsed/Refractory (R/R) Follicular Lymphoma (FL) and in Combination With Rituximab in R/R Diffuse Large B-Cell Lymphoma (DLBCL) Participants

  • Cancer
  • Non-Hodgkin's Lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL)
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:

Terminated

This trial runs in
Countries
  • Australia
  • Germany
  • Korea, Republic of
  • New Zealand
  • South Korea
  • United States
Trial Identifier:

NCT02624986 2015-002100-83 BH29812

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      The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

      The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

      Results Disclaimer

      Trial Summary

      This is a open-label, multicenter, non-randomized, study to evaluate the safety, efficacy, and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with R/R FL and rituximab in combination with idasanutlin in R/R DLBCL. The study will include an initial dose-escalation phase followed by an expansion phase. The dose-escalation phase is designed to determine the recommended phase 2 dose (RP2D) for idasanutlin in combination with obinutuzumab for FL and in combination with rituximab for DLBCL. The expansion phase is designed to further assess the safety and efficacy of obinutuzumab in combination with idasanutlin at the RP2D with the selected regimen in participants with R/R FL and of rituximab in combination with idasanutlin at the RP2D in participants with R/R DLBCL.

      Hoffmann-La Roche Sponsor
      Phase 1/Phase 2 Phase
      NCT02624986,BH29812,2015-002100-83 Trial Identifier
      Idasanutlin, Obinutuzumab, Rituximab Treatments
      Non-Hodgkin's Lymphoma Condition
      Official Title

      A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

      Eligibility Criteria

      All Gender
      ≥ 18 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
      • Histologically documented cluster of differentiation (CD) 20-positive B-cell lymphoma classified as relapsed or refractory FL or DLBCL after treatment with at least two prior chemoimmunotherapy regimens that included an anti-CD20 monoclonal antibody (mAb) and for which no other more appropriate treatment option exists
      • At least one bidimensionally measurable lesion
      • Agreement to remain abstinent or use adequate contraception, among women or men of childbearing potential
      Exclusion Criteria
      • Known CD20-negative status at relapse or progression
      • Prior allogeneic stem cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
      • Current use of systemic corticosteroids greater than (>) 20 mg prednisone per day (or equivalent), or prior anti-cancer therapy to include: radioimmunoconjugate within 12 weeks; mAb or antibody-drug conjugate within 4 weeks; or radiotherapy/chemotherapy/hormone therapy/targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
      • Requirement for chronic anticoagulation
      • Central nervous system (CNS) disease
      • Active infection
      • Positive for human immunodeficiency virus (HIV) or hepatitis B or C
      • Receipt of a live virus vaccine within 28 days prior to Day 1 of Cycle 1
      • Poor hematologic, renal, or hepatic function
      • Pregnant or lactating women
      • History of progressive multifocal leukoencephalopathy (PML)

      For the latest version of this information please go to www.forpatients.roche.com

       

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