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

History of Changes

Purpose

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.

Condition	Intervention	Phase
Relapsed or Refractory Mantle Cell Lymphoma	Drug: Ibrutinib	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	An Open-Label Treatment Use Protocol for Ibrutinib (PCI-32765) in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Ibrutinib

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Mantle Cell Lymphoma

U.S. FDA Resources

Further study details as provided by Janssen Biotech, Inc.:

Primary Outcome Measures:

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.


Enrollment:	163
Actual Study Start Date:	May 15, 2013
Estimated Study Completion Date:	July 31, 2017
Estimated Primary Completion Date:	July 31, 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ibrutinib Ibrutinib	Drug: Ibrutinib Ibrutinib

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833039

Show 52 Study Locations

Sponsors and Collaborators

Janssen Biotech, Inc.

Pharmacyclics LLC.

More Information


Responsible Party:	Janssen Biotech, Inc.
ClinicalTrials.gov Identifier:	NCT01833039 History of Changes
Other Study ID Numbers:	CR101862 PCI-32765MCL4001 ( Other Identifier: Janssen )
Study First Received:	April 6, 2013
Last Updated:	May 12, 2017


Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Janssen Biotech, Inc.:


Mantle Cell Lymphoma Ibrutinib

Additional relevant MeSH terms:


Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders	Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on June 23, 2017

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