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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
Information provided by (Responsible Party):
Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT01833039
First received: April 6, 2013
Last updated: October 2, 2014
Last verified: October 2014

April 6, 2013
October 2, 2014
May 2013
October 2015   (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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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: Open Label
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
150
May 2016
October 2015   (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT01833039
CR101862, PCI-32765MCL4001
No
Janssen Biotech, Inc.
Janssen Biotech, Inc.
Pharmacyclics
Not Provided
Janssen Biotech, Inc.
October 2014

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