A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-free Survival (PFS)
PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir. Study terminated prematurely. Analysis not conducted.
up to 7 years
No
Martin Dreyling, Prof. Dr
Principal Investigator
Medizinische Klinik III der Universität München
United States: Food and Drug Administration
CC-5013-MCL-003
NCT01021423
April 2010
March 2011
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Arena Oncology Associates | Great Neck, New York 11021 |
SUNY Upstate Medical University | Syracuse, New York 13210 |
Nebraska Hematology-Oncology, PC | Lincoln, Nebraska 68506 |
University of Virginia Health Systems | Charlottesville, Virginia 22908-0386 |
Sharp Healthcare Oncology Associates of San Diego | San Diego, California 92123 |
Providence Cancer Center | Indianapolis, Indiana 97213 |
Weill Cornell Medical College/New York Presbyterian Hospital | New York, New York 10021 |