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

Status:	Active, not recruiting
Conditions:	Lymphoma, Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	1/23/2019
Start Date:	December 23, 2015
End Date:	May 2, 2019

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

This is a open-label, mutlicenter, 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.

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)

We found this trial at

sites

University of Colorado

Aurora, Colorado 80045

from

Aurora, CO