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A Phase 2, Multicenter, Single-Arm, Open-Label Study To Determine The Efficacy And Safety Of Single-Agent Lenalidomide (Revlimid®) In Patients With Mantel Cell NHL Who Have Relapsed Or Progressed After Treatment With Bortezomib Or Are Refractory To Bortezomib
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation. Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first. 10 October 2017: In regard to the last subject last visit date/study completion date, the prolongation of timelines is due to the bridging of a treatment gap for a patient responding to study medication until non-study medication is available.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
UCSD Moores Cancer Center
La Jolla, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Tower Cancer Research Foundation
Los Angeles, California, United States
Boca Raton Community Hospital, Inc., Research Dept.
Boca Raton, Florida, United States
Pasco Hernando Oncology Associates, PA
Brooksville, Florida, United States
Broward General Medical Center
Fort Lauderdale, Florida, United States
MD Anderson Cancer Center, Orlando Regional Healthcare
Orlando, Florida, United States
Lake County Oncology and Hematology
The Villages, Florida, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, United States
Start Date
December 22, 2008
Primary Completion Date
April 6, 2016
Completion Date
November 8, 2017
Last Updated
December 13, 2018
134
ACTUAL participants
lenalidomide
DRUG
Lead Sponsor
Celgene
NCT06263491
NCT05529069
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 ConditionsNCT05006716