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NCT01855750 · ClinicalTrials.gov registry record · Phase 3

A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

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

Completed
Registry status
Phase 3
Development phase
838
Enrollment target
20
Study locations

NCT01855750 is a Phase 3 study of Lymphoma that has completed, run by Janssen Research & Development. The registered enrollment target is 838 participants, above the 481-participant average among 299 other Lymphoma trials with a reported enrollment target (74% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT01855750, a Phase 3 study of Lymphoma, has completed, sponsored by Janssen Research & Development.

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

Study Summary

The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL) selected by immunohistochemistry (IHC) or newly diagnosed patients with activated B cell-like (ABC) subtype of DLBCL identified by gene expression profiling (GEP) or both populations.

Conditions Studied

Lymphoma

Interventions

  • DRUG Cyclophosphamide
  • DRUG Placebo
  • DRUG Doxorubicin
  • DRUG Rituximab
  • DRUG Ibrutinib

Study Locations (20)

California

  • - Greenbrae
  • - La Jolla
  • - Los Angeles
  • - Salinas
  • - Stanford

Indiana

  • - Fort Wayne
  • - Goshen
  • - Indianapolis

Connecticut

  • - Danbury
  • - Hartford

Georgia

  • - Atlanta
  • - Marietta

Louisiana

  • - Baton Rouge
  • - New Orleans

Arizona

  • - Tucson

District of Columbia

  • - Washington D.C.

Illinois

  • - Peoria

Trial Details

FieldValue
Enrollment Target 838 participants
Start Date 2013-09-03
Est. Completion 2019-04-05
Phase Phase 3

Sponsor

Janssen Research & Development

593 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01855750

The ClinicalTrials.gov registry entry for NCT01855750 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 838 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 481-participant average among 299 other Lymphoma trials with a reported enrollment target (74% 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 Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01855750 reports 20 study locations spanning 11 distinct geographic areas - top geographies include California, Indiana, Connecticut.

Frequently Asked Questions

What is clinical trial NCT01855750 about?

NCT01855750 is a clinical study titled "A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma". The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lympho...

What is the current status of trial NCT01855750?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 838 participants. The study started on 2013-09-03. Estimated completion is 2019-04-05.

What conditions does trial NCT01855750 study?

This clinical trial studies the following conditions: Lymphoma.

What interventions are being tested in trial NCT01855750?

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

Who is sponsoring clinical trial NCT01855750?

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

Where is trial NCT01855750 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, District of Columbia, Georgia. 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.