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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01833039
First received: April 6, 2013
Last updated: May 12, 2017
Last verified: May 2017
April 6, 2013
May 12, 2017
May 15, 2013
July 31, 2017   (Final data collection date for primary outcome measure)
Percentage of Patients With Treatment Emergent Adverse Experiences during the study. [ Time Frame: Start of study drug to 30 Days post study drug administration ]
Percentage of Patients With Treatment Emergent Adverse Experiences during the study.
Number of Patients with Adverse Events as a Measure of Safety [ Time Frame: Start of study drug to 30 Days post study drug administration ]
The Number of Patients With Treatment Emergent Adverse Experiences of Interest During The Study. Averse Experiences of Interest are: Major Hemorrhage, Intracranial Hemorrhage, Pregnancy.
Complete list of historical versions of study NCT01833039 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Relapsed or Refractory Mantle Cell Lymphoma
Drug: Ibrutinib
Ibrutinib
Experimental: Ibrutinib
Ibrutinib
Intervention: Drug: Ibrutinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
163
July 31, 2017
July 31, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Puerto Rico,   United States
 
 
NCT01833039
CR101862
PCI-32765MCL4001 ( Other Identifier: Janssen )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Pharmacyclics LLC.
Not Provided
Janssen Biotech, Inc.
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP