SHS_492368 PAGJ CGEN 16186

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

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

Inclusion Criteria:

• Age greater than or equal to (>/=) 18 years

• 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 either of the following: relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody (mAb) and for which no other more appropriate treatment option exists, or relapsed or refractory DLBCL after treatment with at least one prior chemoimmunotherapy regimen and for which autologous stem-cell transplantation (SCT) is not indicated

• 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

• Central nervous system (CNS) disease

• Prior allogeneic SCT, or autologous SCT within 100 days prior to Day 1 of Cycle 1

• Current use of systemic immunosuppressant(s), or prior anti-cancer therapy to include: lenalidomide, fludarabine, or alemtuzumab within 12 months; 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

• 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

• Life expectancy less than (<) 3 months
Phase I/II
NCT03135262
Cancer
Hematologic
John Pagel, M.D.
Genentech
Neil Bailey
  • Swedish Medical Center