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) |
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.
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
30
sites
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
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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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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1500 East Duarte Road
Duarte, California 91010
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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Ingalls Memorial Hospital As the area's only independent not-for-profit healthcare system, Ingalls has the ability...
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
Jacksonville, Florida 32256
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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