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A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma

A Phase Ib Study of the Safety and Pharmacology of Atezolizumab Administered With Obinutuzumab in Patients With Relapsed/Refractory Follicular Lymphoma or Atezolizumab Administered With Obinutuzumab or Tazemetostat in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT02220842•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This open-label, multicenter, global study is designed to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of intravenous atezolizumab (MPDL3280A) and obinutuzumab in participants with refractory or relapsed follicular lymphoma (FL) or atezolizumab and obinutuzumab or tazemetostat administered in participants with refractory or relapsed diffuse large B-cell lymphoma (DLBCL). The anticipated duration of this study is approximately 4.5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically documented, CD20-positive, relapsed or refractory (defined as having relapsed within 6 months to the previous treatment) FL or DLBCL (including primary mediastinal large B-cell lymphoma \[PMLBCL\])
•Bone marrow biopsy at screening (unless it was performed within 3 months prior to screening)
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
•Life expectancy greater than or equal to (\>=) 12 weeks
•Has a QT interval corrected by Fridericia's formula (QTcF) less than or equal to (\<=) 480 milliseconds (msec)
•At least one bi-dimensionally measurable nodal lesion \>1.5 cm in its longest diameter by computed tomography (CT) scan or MRI, as defined by the Lugano Classification
•Adequate hematologic and end-organ function
•Archival tumor tissue
•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 90 days after the last dose of atezolizumab or 18 months after the last dose of obinutuzumab, whichever is longer
•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm
+19 more criteria

Exclusion Criteria

•Known central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation from an indolent lymphoma to a high-grade or DLBCL

Locations (15)

City of Hope National Medical Center

Duarte, California, United States

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Sloan Kettering Cancer Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

UW- Fred Hutchinson Cancer Center

Seattle, Washington, United States

Hopital Claude Huriez - CHU Lille; Service des maladies du sang

Lille, France

Hopital Saint Eloi

Montpellier, France

Hôpital Saint-Louis

Paris, France

Key Dates

Start Date

December 18, 2014

Primary Completion Date

January 21, 2020

Completion Date

January 21, 2020

Last Updated

January 27, 2020

Enrollment

ACTUAL participants

Conditions

Lymphoma

Interventions

Atezolizumab

DRUG

Obinutuzumab

DRUG

Tazemetostat

DRUG

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

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RECRUITINGPHASE2/PHASE3

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Safety and Pharmacology Study of Atezolizumab (MPDL3280A) Administered With Obinutuzumab or Tazemetostat in Participants With Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

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U69-CART-Cells For R/R T-ALL