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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

NCT01855750 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 838

Last updated 2025-02-04

Study results available
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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

Interventions

DRUG

Ibrutinib

560 mg capsules administered by mouth once daily (21-day cycles)

DRUG

Placebo

4 matched capsules administered by mouth once daily (21-day cycles)

DRUG

Rituximab

375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Cyclophosphamide

750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Doxorubicin

50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Vincristine

1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)

DRUG

Prednisone (or equivalent)

100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-03
Primary Completion
2018-02-26
Completion
2019-04-05

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01855750 on ClinicalTrials.gov