search
Back to results

An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Primary Purpose

Relapsed or Refractory Mantle Cell Lymphoma

Status
Approved for marketing
Phase
Locations
International
Study Type
Expanded Access
Intervention
Ibrutinib
Sponsored by
Janssen Biotech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Relapsed or Refractory Mantle Cell Lymphoma focused on measuring Mantle Cell Lymphoma, Ibrutinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible.

Exclusion Criteria:

  • Patients eligible for enrollment in any other ongoing clinical study of ibrutinib are not eligible.
  • Patients previously treated with ibrutinib are not eligible.
  • Patients enrolled in another interventional clinical study with therapeutic intent are not eligible.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 6, 2013
Last Updated
November 6, 2018
Sponsor
Janssen Biotech, Inc.
Collaborators
Pharmacyclics LLC.
search

1. Study Identification

Unique Protocol Identification Number
NCT01833039
Brief Title
An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Official Title
An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Study Type
Expanded Access

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Biotech, Inc.
Collaborators
Pharmacyclics LLC.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell Lymphoma (MCL) with early access to an investigational medication called ibrutinib (PCI-32765) and to collect safety information about the drug.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Mantle Cell Lymphoma
Keywords
Mantle Cell Lymphoma, Ibrutinib

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Intervention Description
Ibrutinib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients, 18 years of age and older, with Mantle Cell Lymphoma who have relapsed or refractory disease after prior therapy are eligible. Exclusion Criteria: Patients eligible for enrollment in any other ongoing clinical study of ibrutinib are not eligible. Patients previously treated with ibrutinib are not eligible. Patients enrolled in another interventional clinical study with therapeutic intent are not eligible.
Facility Information:
City
Phoenix
State/Province
Arizona
Country
United States
City
Duarte
State/Province
California
Country
United States
City
La Jolla
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
Stanford
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Norwalk
State/Province
Connecticut
Country
United States
City
Stamford
State/Province
Connecticut
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Brandon
State/Province
Florida
Country
United States
City
Miami Beach
State/Province
Florida
Country
United States
City
Ocala
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Palm Beach Gardens
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Springfield
State/Province
Illinois
Country
United States
City
Goshen
State/Province
Indiana
Country
United States
City
Sioux City
State/Province
Iowa
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Detroit
State/Province
Michigan
Country
United States
City
Rochester
State/Province
Minnesota
Country
United States
City
Jefferson City
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Reno
State/Province
Nevada
Country
United States
City
Hackensack
State/Province
New Jersey
Country
United States
City
New Hyde Park
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Durham
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Hershey
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Watertown
State/Province
South Dakota
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Morgantown
State/Province
West Virginia
Country
United States
City
Madison
State/Province
Wisconsin
Country
United States
City
Barretos
Country
Brazil
City
Florianopolis
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Rio De Janeiro
Country
Brazil
City
Salvador
Country
Brazil
City
Sao Paulo
Country
Brazil
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_7051&studyid=4530&filename=CR101862_CSR.pdf
Description
An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Learn more about this trial

An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

We'll reach out to this number within 24 hrs