A Study of Obinutuzumab, Polatuzumab Vedotin, and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (FL) and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:March 23, 2016
End Date:February 23, 2022
Contact:Reference Study ID Number: GO29834 www.roche.com/about_roche/roche_worldwide.htm
Email:global.rochegenentechtrials@roche.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Polatuzumab Vedotin and Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma and Rituximab in Combination With Polatuzumab Vedotin and Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study will evaluate the safety, efficacy, and pharmacokinetics of induction treatment
with obinutuzumab, polatuzumab vedotin, and lenalidomide in participants with relapsed or
refractory (R/R) follicular lymphoma (FL) and rituximab in combination with polatuzumab
vedotin and lenalidomide in participants with R/R diffuse large B-cell lymphoma (DLBCL),
followed by post-induction treatment with obinutuzumab in combination with lenalidomide in
participants with FL who achieve a complete response (CR), partial response (PR), or stable
disease (SD) at end of induction (EOI) and post-induction treatment with rituximab plus
lenalidomide in participants with DLBCL who achieve a CR or PR at EOI.


Inclusion Criteria:

- Age greater than or equal to (>/=) 18 years

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- For obinutuzumab in combination with polatuzumab vedotin and lenalidomide (G + Pola +
Len) treatment group: R/R FL after treatment with at least one prior
chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for
which no other more appropriate treatment option exists as determined by the
investigator

- For rituximab in combination with polatuzumab vedotin and lenalidomide (R + Pola +
Len) treatment group: R/R DLBCL after treatment with at least one prior
chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in patients
who are not eligible for autologous stem-cell transplantation or who have experienced
disease progression following treatment with high-dose chemotherapy plus autologous
stem-cell transplantation

- Histologically documented CD20-positive B-cell lymphoma as determined by the local
laboratory

- fluorodeoxyglucose (FDG)-avid lymphoma (i.e., positron emission tomography
(PET)-positive lymphoma)

- At least one bi-dimensionally measurable lesion

- Agreement to remain abstinent or use adequate contraception, among women or men of
childbearing potential

Exclusion Criteria:

- Grade 3b follicular lymphoma

- History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)

- Known CD20-negative status at relapse or progression

- Central nervous system (CNS) lymphoma or leptomeningeal infiltration

- Prior allogeneic stem-cell transplantation (SCT), or autologous SCT within 100 days
prior to Day 1 of Cycle 1

- Current use of systemic immunosuppressant(s), or prior anti-cancer therapy to include:
lenalidomide, fludarabine, or alemtuzumab within 12 months; 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

- Active infection

- 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 less than (<) 3 months
We found this trial at
9
sites
Marietta, Georgia 30060
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Marietta, GA
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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1 Hospital Dr
Columbia, Missouri 65212
(573) 882-2100
University of Missouri-Ellis Fischel Ellis Fischel Cancer Center's team of physician specialists and other trained...
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Columbia, MO
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199-203 Avinguda de la Granvia
Hospitalet de Llobregat, Barcelona 08908
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Hospitalet de Llobregat,
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7415 Las Colinas Boulevard
Irving, Texas 75063
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Irving, TX
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Irving, Texas 75063
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Irving, TX
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New York, New York 10016
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New York, NY
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660 South Euclid Avenue
Saint Louis, Missouri 63110
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Saint Louis, MO
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San Antonio, TX
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