Non Hodgkin Lymphoma Clinical Trial
A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
Summary
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.
Eligibility Criteria
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 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
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There are 23 Locations for this study
Tucson Arizona, 85719, United States
New Haven Connecticut, 06520, United States
Pembroke Florida, 33028, United States
Atlanta Georgia, 30322, United States
Louisville Kentucky, 40202, United States
Ann Arbor Michigan, 48109, United States
New Brunswick New Jersey, 08901, United States
Buffalo New York, 14263, United States
Philadelphia Pennsylvania, 19111, United States
Temple Texas, 76508, United States
St. Leonards New South Wales, 2065, Australia
Waratah New South Wales, 2298, Australia
Woolloongabba Queensland, 4102, Australia
Adelaide South Australia, 5011, Australia
Hobart Tasmania, 7000, Australia
North Melbourne Victoria, 3051, Australia
Bergamo Emilia-Romagna, 24127, Italy
Meldola Emilia-Romagna, 47014, Italy
Ravenna Emilia-Romagna, 48121, Italy
Rimini Emilia-Romagna, 47923, Italy
Milano Lombardia, 20133, Italy
Novara Piemonte, 28100, Italy
Torino Piemonte, 10126, Italy
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