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.

View Eligibility Criteria

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 milligrams (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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

133

Study ID:

NCT02611323

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 23 Locations for this study

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University of Arizona Cancer Center
Tucson Arizona, 85719, United States
Yale Cancer Center
New Haven Connecticut, 06520, United States
Memorial Healthcare System
Pembroke Florida, 33028, United States
Emory Univ Winship Cancer Inst
Atlanta Georgia, 30322, United States
University of Louisville Hospital; The James Graham Brown Cancer Center
Louisville Kentucky, 40202, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Roswell Park Cancer Inst.
Buffalo New York, 14263, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Scott and White
Temple Texas, 76508, United States
Royal North Shore Hospital; Haematology Department
St. Leonards New South Wales, 2065, Australia
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
The Queen Elizabeth Hospital
Adelaide South Australia, 5011, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
Peter MacCallum Cancer Center
North Melbourne Victoria, 3051, Australia
Papa Giovanni Hospital XXIII
Bergamo Emilia-Romagna, 24127, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola Emilia-Romagna, 47014, Italy
UO Ematologia, Ospedale S.Maria delle Croci
Ravenna Emilia-Romagna, 48121, Italy
Ospedale Infermi U.O. Ematologia
Rimini Emilia-Romagna, 47923, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milano Lombardia, 20133, Italy
SCDU Ematologia
Novara Piemonte, 28100, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Torino Piemonte, 10126, Italy

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

133

Study ID:

NCT02611323

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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