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A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

A Phase IB/II Study Evaluating The Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin in Combination With Rituximab (R) or Obinutuzumab (G) Plus Bendamustine (B) in Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

NCT02257567•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with standard doses of bendamustine (B) and rituximab (R) or obinutuzumab (G) in participants with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL). The study comprises two stages: a Phase Ib safety run-in stage and a Phase II stage. The anticipated time on treatment is 18 weeks for participants with DLBCL and 24 weeks for participants with FL.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed relapsed or refractory FL (Grades 1, 2, or 3a) or relapsed or refractory DLBCL
•If the participant has received prior bendamustine, response duration must have been greater than (\>) 1 year (for participants who have relapse disease after a prior regimen)
•At least one bi-dimensionally measurable lesion on imaging scan defined as \>1.5 centimeters (cm) in its longest dimension
•Confirmed availability of archival or freshly collected tumor tissue
•The Phase II NF Cohorts (Arms G and H) will be required to submit tissue and pathology report for central pathology review.
•Life expectancy of at least 24 weeks
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
•Adequate hematological function unless inadequate function is due to underlying disease

Exclusion Criteria

•History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (MAbs, or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
•Contraindication to bendamustine, rituximab, or obinutuzumab
•Prior use of any MAb, radioimmunoconjugate, or antibody-drug conjugate (ADC) within 4 weeks or 5 half-lives before Cycle 1 Day 1
•Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
•Ongoing corticosteroid use \>30 mg per day prednisone or equivalent, for purposes other than lymphoma symptom control
•Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1 Day 1
•Prior allogeneic SCT
•Eligibility for autologous SCT
•Grade 3b FL
•History of transformation of indolent disease to DLBCL
+10 more criteria

Locations (62)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Clearview Cancer Institute

Huntsville, Alabama, United States

City of Hope National Medical Center

Duarte, California, United States

Univ of Colorado Canc Ctr

Aurora, Colorado, United States

Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)

Jacksonville, Florida, United States

Emory Univ Winship Cancer Inst

Atlanta, Georgia, United States

Joliet Oncology-Hematology; Associates, Ltd.

Joliet, Illinois, United States

Horizon Oncology Research, Inc.

Lafayette, Indiana, United States

Weinberg CA Inst Franklin Sq

Baltimore, Maryland, United States

Regional Cancer Care Associates LLC - Morristown

Morristown, New Jersey, United States

Key Dates

Start Date

October 15, 2014

Primary Completion Date

October 21, 2021

Completion Date

October 21, 2021

Last Updated

November 14, 2022

Enrollment

331

ACTUAL participants

Conditions

Lymphoma

Interventions

Bendamustine

DRUG

Obinutuzumab

DRUG

Polatuzumab vedotin (Liquid)

DRUG

Rituximab

DRUG

Polatuzumab vedotin (Lyophilized)

DRUG

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

NCT06337318

Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features

View study

RECRUITINGPHASE1

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

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

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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: November 14, 2022Data 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.

View ClinicalTrials.gov Terms and Conditions

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

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)

Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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