A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL

  • STATUS
    Not Recruiting
  • End date
    Dec 16, 2023
  • participants needed
    172
  • sponsor
    Hoffmann-La Roche
Updated on 14 September 2022
ct scan
renal function
cancer
cyclophosphamide
hodgkin's disease
rituximab
vincristine
prednisone
measurable disease
doxorubicin
anthracyclines
diffuse large b-cell lymphoma
b-cell lymphoma
tocilizumab
large b-cell lymphoma
r-chop
obinutuzumab
chop regimen
r-chop regimen

Summary

This is a phase 1B, multi-center, dose-finding study of glofitamab 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 G/R CHOP or Pola-R-CHP in participants with 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; test use of G vs R in Cycle 1
  • Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with untreated DLBCL (>18 years of age with an age-adjusted International Prognostic Index (IPI) of 2-5). Glofitamab will be studied in combination with R-CHOP and Pola-R-CHP.

Details
Condition B-Cell Lymphoma, Non-Hodgkin Lymphoma
Treatment cyclophosphamide, prednisone, Tocilizumab, vincristine, doxorubicin, Polatuzumab Vedotin, RO7082859, Obinutuzumab (G), Rituximab (R), Glofitamab
Clinical Study IdentifierNCT03467373
SponsorHoffmann-La Roche
Last Modified on14 September 2022

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