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A Multicenter, Observational Study to Evaluate the Effectiveness of Lenalidomide (Revlimid®) in Subjects With Mantle Cell Lymphoma Who Have Relapsed or Progressed After Treatment With Ibrutinib or Are Refractory or Intolerant to Ibrutinib.
The objective of this study is to determine the effectiveness of lenalidomide in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL) following ibrutinib treatment. MCL subjects who require treatment after receiving ibrutinib therapy are considered a population with high unmet medical need. It is therefore of benefit to have data on the outcomes of treatment options available in this patient population. An observational study design was chosen to collect the clinical data already existing or being collected for MCL subjects being treated with lenalidomide. MCL subjects who received lenalidomide either as monotherapy or as combination treatment after having relapsed or progressed on ibrutinib treatment or were refractory or intolerant to ibrutinib treatment are eligible for the study. Lenalidomide does not need to be the next subsequent treatment after ibrutinib.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic Scottsdale
Phoenix, Arizona, United States
Innovative Clinical Research Institute
Whittier, California, United States
University of Miami and Sylvester Comprehensive Cancer
Miami, Florida, United States
University of Michigan Comprehensive Cancer Center Division of Hematology Oncology
Ann Arbor, Michigan, United States
Columbia Comprehensive Cancer Care Clinic
Jefferson City, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Start Date
April 1, 2015
Primary Completion Date
September 1, 2016
Completion Date
September 1, 2016
Last Updated
January 26, 2017
30
ACTUAL participants
Lead Sponsor
Celgene
NCT04911478
NCT03567876
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02278796