Last updated on November 2018

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.


Brief description of study

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

Detailed Study Description

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.

Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study.

Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.

Clinical Study Identifier: NCT03229200

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Raul Mena

Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center
Burbank, CA United States

Robert Chen

City Of Hope National Medical Center
Duarte, CA United States

Sven DeVos

University of California Los Angeles (UCLA)
Los Angeles, CA United States

Shuo Ma

Northwestern University
Chicago, IL United States

Nalini Janakiraman

Henry Ford Health System
Detroit, MI United States

Regan Holdridge

TRIO - Comprehensive Cancer Centers of Nevada
Las Vegas, NV United States

Morton Coleman

Clinical Research Alliance
Lake Success, NY United States

Jacqueline C Barrientos

Northwell Health
New Hyde Park, NY United States

Lia Palomba

Memorial Sloan Kettering Cancer Center
New York, NY United States

Mark Knapp

Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center
Columbus, OH United States

William C Ehmann

Penn State Milton S. Hershey Medical Center
Hershey, PA United States

Nathan Fowler

University of Texas MD Anderson Cancer Center
Houston, TX United States

Drew Rasco

START - South Texas Accelerated Research Therapeutics, LLC
San Antonio, TX United States

Joseph Rosenblatt

University of Miami Sylvester Comprehensive Cancer Center
Miami, FL United States

Sonali Smith

University of Chicago
Chicago, IL United States

Tycel Phillips

University of Michigan Health System
Ann Arbor, MI United States

Andre Goy

John Theurer Cancer Center, Hackensack UMC
Hackensack, NJ United States

Jakub Svoboda

University of Pennsylvania Abramson Cancer Center
Philadelphia, PA United States

Hervé Tilly

Centre Henri Becquerel
Rouen Cedex, France

Steven Coutre

Stanford University
Stanford, CA United States

Jennifer Brown

Dana-Farber Cancer Institute
Boston, MA United States

Paul Barr

University of Rochester
Rochester, NY United States

John Byrd

The Ohio State University
Columbus, OH United States

Siva Mannem

Yakima Valley Memorial Hospital
Yakima, WA United States

Viktor Fedorov, MD

Hospital de Sanata Creus i Sant Pau
Barcelona, Spain

Viktor Fedorov, MD

UCSD Moores Cancer Center
La Jolla, CA United States

Viktor Fedorov, MD

Weill Cornell Medical College-New York Presbyterian Hospital
New York, NY United States