Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
