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Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

NCT02165397 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2021-03-03

Study results available
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Summary

The purpose of this study is to evaluate the safety and efficacy of ibrutinib in combination with rituximab in participants with Waldenström's macroglobulinemia (WM).

Conditions

  • Waldenström's Macroglobulinemia

Interventions

DRUG

Ibrutinib

Participants will receive 420 mg of Ibrutinib orally.

DRUG

Placebo

Participants will receive placebo capsules orally.

DRUG

Rituximab

Participants will receive rituximab 375 mg/m\^2 IV.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    collaborator INDUSTRY

  • Pharmacyclics LLC.

    lead INDUSTRY

Principal Investigators

  • Bernhard Hauns, MD · Pharmacyclics LLC.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-07
Primary Completion
2019-11-07
Completion
2019-11-07
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Greece
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02165397 on ClinicalTrials.gov