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NCT02257567 · ClinicalTrials.gov registry record · Phase 1

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 1 study of Lymphoma, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
331
Enrollment target
20
Study locations

NCT02257567 is a Phase 1 study of Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 331 participants, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT02257567, a Phase 1 study of Lymphoma, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
331 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

Lymphoma

Interventions

  • DRUG Obinutuzumab
  • DRUG Rituximab
  • DRUG Bendamustine
  • DRUG Polatuzumab vedotin (Liquid)
  • DRUG Polatuzumab vedotin (Lyophilized)

Study Locations (20)

Alabama

  • University of Alabama at Birmingham - Birmingham
  • Clearview Cancer Institute - Huntsville

Washington

  • Swedish Cancer Inst. - Seattle
  • Northwest Medical Specialties - Tacoma

South Australia

  • Royal Adelaide Hospital - Adelaide
  • Adelaide Cancer Centre - Kurralta Park

California

  • City of Hope National Medical Center - Duarte

Colorado

  • Univ of Colorado Canc Ctr - Aurora

Florida

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

Georgia

  • Emory Univ Winship Cancer Inst - Atlanta

Illinois

  • Joliet Oncology-Hematology; Associates, Ltd. - Joliet

Trial Details

FieldValue
Enrollment Target 331 participants
Start Date 2014-10-15
Est. Completion 2021-10-21
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02257567

The ClinicalTrials.gov registry entry for NCT02257567 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 331 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 483-participant average among 299 other Lymphoma trials with a reported enrollment target (31% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.

NCT02257567 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Alabama, Washington, South Australia.

Frequently Asked Questions

What is clinical trial NCT02257567 about?

NCT02257567 is a clinical study titled "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". 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 lym...

What is the current status of trial NCT02257567?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 331 participants. The study started on 2014-10-15. Estimated completion is 2021-10-21.

What conditions does trial NCT02257567 study?

This clinical trial studies the following conditions: Lymphoma.

What interventions are being tested in trial NCT02257567?

The interventions under investigation include: Obinutuzumab (DRUG), Rituximab (DRUG), Bendamustine (DRUG), Polatuzumab vedotin (Liquid) (DRUG), Polatuzumab vedotin (Lyophilized) (DRUG).

Who is sponsoring clinical trial NCT02257567?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02257567 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.