SHS_492308 PAGJ CGEN 15248

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

This study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin in combination with obinutuzumab in participants with relapsed or refractory FL or DLBCL. Participants with FL who achieve complete response (CR), partial response (PR), or stable disease (SD) at the end of induction therapy (EOI) will be eligible for post-induction treatment with obinutuzumab.

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 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 milligrams (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)
Phase I/II
NCT02624986
Cancer
Hematologic
John Pagel, M.D.
Genentech
Neil Bailey
  • Swedish Medical Center