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Completed Phase 3 Interventional Results available

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

ClinicalTrials.gov ID: NCT02165397

Public ClinicalTrials.gov record NCT02165397. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 7, 2026, 1:34 PM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Official title

iNNOVATE Study: A Randomized, Double-Blind, Placebo- Controlled, Phase 3 Study of Ibrutinib or Placebo in Combination With Rituximab in Subjects With Waldenström's Macroglobulinemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT02165397
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Pharmacyclics LLC.
Industry
Enrollment
181 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 7, 2014 (Actual)
Primary completion
Nov 7, 2019 (Actual)
Completion
Nov 7, 2019 (Actual)
Last update posted
Mar 3, 2021

2014 – 2019

United States locations

U.S. sites
10
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
University of California Los Angeles Los Angeles California 90404 —
Stanford Cancer Center Palo Alto California 94305 —
Colorado Blood Cancer Institute Denver Colorado 80218 —
Emory University Hospital Atlanta Georgia 30322 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
Weill Cornell Medical Center New York New York 10065 —
Vanderbilt University Medical Center Nashville Tennessee 37204 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 38 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02165397, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 3, 2021 · Synced Nov 7, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT02165397 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →