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A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma

NCT01974440 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2025-05-25

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.

Conditions

Interventions

DRUG

Bendamustine

90 milligram per meter square (mg/m\^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.

DRUG

Rituximab

375 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

DRUG

Cyclophosphamide

750 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

DRUG

Doxorubicin

50 mg/m\^2 administered intravenously on Day 1 of Cycles 1 to 6.

DRUG

Vincristine

1.4 mg/m\^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.

DRUG

Prednisone

100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.

DRUG

PCI-32765 (Ibrutinib)

560 mg (4\*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.

DRUG

Placebo

Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.

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
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2022-05-30
Completion
2023-06-21

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • China
  • France
  • Germany
  • Israel
  • Japan
  • Poland
  • Puerto Rico
  • Russia
  • South Korea
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

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 NCT01974440 on ClinicalTrials.gov