Clinical trial NCT01833039: 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
Overall status: APPROVED_FOR_MARKETING
Conditions: Relapsed or Refractory Mantle Cell Lymphoma
Keywords: Mantle Cell Lymphoma
Ibrutinib
Lead sponsor: Janssen Biotech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pharmacyclics LLC.
First posted: 2013-04-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Duarte
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Stanford
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Norwalk
country: United States
state: Connecticut
city: Stamford
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Miami Beach
country: United States
state: Florida
city: Ocala
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Goshen
country: United States
state: Indiana
city: Sioux City
country: United States
state: Iowa
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Metairie
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Rochester
country: United States
state: Minnesota
city: Jefferson City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Lincoln
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Reno
country: United States
state: Nevada
city: Hackensack
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Watertown
country: United States
state: South Dakota
city: Knoxville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
city: Morgantown
country: United States
state: West Virginia
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
Study officials:
References: