A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:October 15, 2014
End Date:July 12, 2021
Contact:Reference Study ID Number: GO29365 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

This study is a multicenter, open-label study of polatuzumab vedotin administered by
intravenous (IV) infusion in combination with standard doses of bendamustine (B) and
rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular
lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a
Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18
weeks for participants with DLBCL and 24 weeks for participants with FL.


Inclusion Criteria:

- Histologically confirmed relapsed or refractory FL (Grades 1, 2, or 3a) or relapsed or
refractory DLBCL

- If the participant has received prior bendamustine, response duration must have been
greater than (>) 1 year (for participants who have relapse disease after a prior
regimen)

- At least one bi-dimensionally measurable lesion on imaging scan defined as >1.5
centimeters (cm) in its longest dimension

- Confirmed availability of archival or freshly collected tumor tissue

- The Phase II NF Cohorts (Arms G and H) will be required to submit tissue and pathology
report for central pathology review.

- Life expectancy of at least 24 weeks

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

- Adequate hematological function unless inadequate function is due to underlying
disease

Exclusion Criteria:

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies (MAbs, or recombinant antibody-related fusion proteins) or known
sensitivity or allergy to murine products

- Contraindication to bendamustine, rituximab, or obinutuzumab

- Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4
weeks or 5 half-lives before Cycle 1 Day 1

- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy,
or any investigational agent for the purposes of treating cancer within 2 weeks prior
to Cycle 1 Day 1

- Ongoing corticosteroid use >30 mg per day prednisone or equivalent, for purposes other
than lymphoma symptom control

- Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1
Day 1

- Prior allogeneic SCT

- Eligibility for autologous SCT

- Grade 3b FL

- History of transformation of indolent disease to DLBCL

- Primary or secondary CNS lymphoma

- Current Grade >1 peripheral neuropathy

- Evidence of significant, uncontrolled concomitant diseases that could affect
compliance with the protocol or interpretation of results, including significant
cardiovascular disease (such as New York Heart Association Class III or IV cardiac
disease, myocardial infarction within the last 6 months, unstable arrhythmias, or
unstable angina) or significant pulmonary disease (including obstructive pulmonary
disease and history of bronchospasm)

- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
(excluding fungal infections of nail beds) at study enrollment or any major episode of
infection requiring treatment with IV antibiotics or hospitalization within 4 weeks
prior to Cycle 1 Day 1

- Suspected or latent tuberculosis

- Positive test results for chronic hepatitis B virus (HBV) infection or for hepatitis C
virus (HCV) antibody

- Known history of human immunodeficiency virus (HIV) seropositive status or known
infection with human T-cell leukemia virus 1 (HTLV-1) virus

- Women who are pregnant or lactating or who intend to become pregnant within a year of
the last dose of study treatment in the rituximab cohort or within 18 months of last
dose in the obinutuzumab cohort

- Evidence of laboratory abnormalities in standard renal, hepatic, or coagulation
function tests

- Treatment with chimeric antigen receptor T-cell therapy within 100 days prior to Cycle
1, Day 1
We found this trial at
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Germantown, Tennessee 38138
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1365 Clifton Road
Atlanta, Georgia 30322
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1665 Aurora Court
Aurora, Colorado 80045
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9103 Franklin Square Drive
Baltimore, Maryland 21237
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Birmingham, Alabama 35213
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Brooklyn, New York 11220
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Charlotte, North Carolina 28211
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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Farmington, New Mexico 87401
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Fort Wayne, IN
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1 Ingalls Dr
Harvey, Illinois 60426
(708) 333-2300
Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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Huntington Beach, California 92648
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Huntsville, Alabama 35805
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Jacksonville, Florida 32216
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
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Joliet, IL
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Lafayette, Indiana
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Los Angeles, California 90033
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1055 North Mayfair Road
Milwaukee, Wisconsin 53226
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100 Madison Avenue
Morristown, New Jersey 07962
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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160 East 34th Street
New York, New York 10016
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Norwalk, Connecticut 06856
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Randwick, New South Wales 2031
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Saint Louis, Missouri 63117
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Seattle, Washington 98104
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Tacoma, Washington 98405
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