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)

Use our guide to learn which trials are right for you!

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
11
sites
New Brunswick, New Jersey 08903
?
mi
from
New Brunswick, NJ
Click here to add this to my saved trials
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
1365 Clifton Road
Atlanta, Georgia 30322
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Buffalo, New York 14263
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
601 South Floyd Street
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
Click here to add this to my saved trials
333 Cedar Street
New Haven, Connecticut 06520
(203) 785-4095
Yale Cancer Center Yale Cancer Center combines a tradition of innovative cancer treatment and quality...
?
mi
from
New Haven, CT
Click here to add this to my saved trials
Pembroke, Florida 33028
?
mi
from
Pembroke, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19111
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
St. Leonards, New South Wales 2065
?
mi
from
St. Leonards,
Click here to add this to my saved trials
Temple, Texas
?
mi
from
Temple, TX
Click here to add this to my saved trials
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials