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NCT01776840 · ClinicalTrials.gov registry record · Phase 3

A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

A Phase 3 study of Mantle Cell Lymphoma, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 3
Development phase
523
Enrollment target
20
Study locations

NCT01776840 is a Phase 3 study of Mantle Cell Lymphoma that has completed, run by Janssen Research & Development. The registered enrollment target is 523 participants, above the 99-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (428% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT01776840, a Phase 3 study of Mantle Cell Lymphoma, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 3
Development phase
523 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Rituximab
  • DRUG Ibrutinib
  • DRUG Bendamustine

Study Locations (20)

Illinois

  • - Chicago
  • - Maywood
  • - Niles
  • - Springfield

California

  • - Burbank
  • - La Jolla
  • - Stanford

Connecticut

  • - New Haven
  • - Stamford

Iowa

  • - Iowa City
  • - Sioux City

Kansas

  • - Topeka
  • - Westwood

Kentucky

  • - Lexington
  • - Louisville

Arizona

  • - Tucson

Colorado

  • - Denver

Trial Details

FieldValue
Enrollment Target 523 participants
Start Date 2013-05-16
Est. Completion 2024-06-24
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT01776840

The ClinicalTrials.gov registry entry for NCT01776840 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 523 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 99-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (428% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT01776840 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Illinois, California, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01776840 about?

NCT01776840 is a clinical study titled "A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma". The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.

What is the current status of trial NCT01776840?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 523 participants. The study started on 2013-05-16. Estimated completion is 2024-06-24.

What conditions does trial NCT01776840 study?

This clinical trial studies the following conditions: Mantle Cell Lymphoma.

What interventions are being tested in trial NCT01776840?

The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Ibrutinib (DRUG), Bendamustine (DRUG).

Who is sponsoring clinical trial NCT01776840?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01776840 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.