A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)

Status:	Recruiting
Conditions:	Lymphoma, Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	3/6/2019
Start Date:	March 9, 2016
End Date:	December 9, 2021
Contact:	Reference Study ID Number: GO29833 www.roche.com/about_roche/roche_worldwide.htm
Email:	global-roche-genentech-trials@gene.com
Phone:	888-662-6728 (U.S. and Canada)

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

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

Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- For obinutuzumab + polatuzumab vedotin + venetoclax treatment group, relapsed or
refractory FL after treatment with at least one prior chemoimmunotherapy regimen that
included an anti-cluster of differentiation 20 (CD20) (anti-CD20) monoclonal antibody
(mAb) and for which no other more appropriate treatment option exists, as determined
by the investigator

- For rituximab + polatuzumab vedotin + venetoclax treatment group, relapsed or
refractory DLBCL after treatment with at least one prior chemoimmunotherapy regimen
that included an anti-CD20 mAb and for which no curative option exists as determined
by the investigator

- At least one bidimensionally measurable lesion

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

- Grade 3b FL

- History of transformation of indolent disease to DLBCL

- 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

- Central nervous system (CNS) disease

- Active infection

- Actual or potential cytochrome P450 (CYP) 3A interactions including: requirement for
warfarin; use of strong and moderate CYP3A inhibitors or inducers within 7 days prior
to first dose of venetoclax; or consumption of grapefruit, Seville oranges, or star
fruit within 3 days prior to first dose of venetoclax

- 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 <3 months

We found this trial at

sites

Royal North Shore Hospital; Haematology Department

St. Leonards, New South Wales 2065

from

St. Leonards,