Last updated on October 2018

A Study of RO7082859 in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide Doxorubicin Vincristine and Prednisone (CHOP) in Participants With Non-Hodgkin Lymphomas


Brief description of study

This is a phase 1B, multi-center, dose-finding study of RO7082859 administered in combination with obinutuzumab (Gazyva; [G]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts:

  • Part I: Dose finding in participants with r/r NHL
  • Part II: Dose expansion in which the maximum tolerated dose (MTD) (or optimal biologic dose [OBD]) determined in Part I will be further assessed in participants with r/r NHL and those with untreated DLBCL (>60 years old with an age-adjusted International Prognostic Index [IPI]) of 2-3), and the impact of using G in place of R in Cycle 1 on safety and tolerability will be assessed via a randomized, unblinded, two-arm design in participants with untreated DLBCL.

Clinical Study Identifier: NCT03467373

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Reference Study ID: NP40126 www.roche.com/about_roche/roche_worldwide.htm

Ingalls Memorial Hospital
Harvey, IL United States
8.07miles
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