A Study of Obinutuzumab, Rituximab, Polatuzumab Vedotin, and Venetoclax in Relapsed or Refractory Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL)
Completed · Phase 1/Phase 2
Conditions studied: Non-Hodgkin's Lymphoma
In brief
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.
Key facts
- Study ID
- NCT02611323
- Run by
- Hoffmann-La Roche
- People needed
- 133
- Starts
- 2016-03-09
- Expected to finish
- 2022-08-04
- Last updated by the study team
- 2023-10-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Arizona Cancer Center — Tucson, Arizona, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Memorial Healthcare System — Pembroke, Florida, United States
- Emory Univ Winship Cancer Inst — Atlanta, Georgia, United States
- University of Louisville Hospital; The James Graham Brown Cancer Center — Louisville, Kentucky, United States
- University of Michigan — Ann Arbor, Michigan, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Roswell Park Cancer Inst. — Buffalo, New York, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- Scott and White — Temple, Texas, United States
- Royal North Shore Hospital; Haematology Department — St Leonards, New South Wales, Australia
- Calvary Mater Newcastle — Waratah, New South Wales, Australia
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
- The Queen Elizabeth Hospital — Adelaide, South Australia, Australia
- Royal Hobart Hospital — Hobart, Tasmania, Australia
- Peter MacCallum Cancer Center — North Melbourne, Victoria, Australia
- Papa Giovanni Hospital XXIII — Bergamo, Emilia-Romagna, Italy
- Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori — Meldola, Emilia-Romagna, Italy
- UO Ematologia, Ospedale S.Maria delle Croci — Ravenna, Emilia-Romagna, Italy
- Ospedale Infermi U.O. Ematologia — Rimini, Emilia-Romagna, Italy
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Lombardy, Italy
- SCDU Ematologia — Novara, Piedmont, Italy
- A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia — Turin, Piedmont, Italy
Full record on ClinicalTrials.gov
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