Last updated on August 2018

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular Marginal Zone or Mantle Cell Lymphoma.


Brief description of study

Follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL) are distinct histologic types of B-cell NHL. Lenalidomide is an immunomodulatory agent with direct and immune-mediated mechanisms of action, as well as clinical activity in NHL. Recent studies in frontline and relapsed/refractory NHL show high activity for lenalidomide plus rituximab (R2), supporting further study of this combination.

Detailed Study Description

MAGNIFY (NCT01996865) is a phase 3b, multicenter, open-label study of patients with grades 1-3b or transformed follicular lymphoma (FL), marginal zone lymphoma (MZL), or mantle cell lymphoma (MCL) who received 1 prior therapy and had stage I-IV, measurable disease. ~500 patients are planned for enrollment in 12 cycles of R2 induction, with a projected ~314 patients with SD after induction randomized (1:1) to two maintenance arms. Induction includes oral lenalidomide 20 mg/day, days 1-21 per 28-day cycle (d1-21/28) plus IV rituximab 375 mg/m2, days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 3, 5, 7, 9, and 11 (28-day cycles). Patients are then randomized to maintenance lenalidomide 10 mg/day, d1-21/28, cycles 13-30, plus rituximab 375 mg/m2, day 1 of cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 (R2, Arm A), or rituximab alone (same schedule, Arm B). Patients receiving R2 maintenance after 18 cycles may continue maintenance lenalidomide monotherapy 10 mg/day, d1-21/28 (per patient and/or investigator discretion), until disease progression as tolerated. The primary endpoint is progression-free survival (per modified 1999 IWG criteria). Secondary endpoints include safety, overall survival, response rates, duration of response, and quality of life (exploratory). Patients will be followed for 5 years after the last patient initiated induction therapy. Enrollment in MAGNIFY began in March 2014; as of Jan 2016, 133 patients are enrolled.

Clinical Study Identifier: NCT01996865

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Arizona Oncology
Tucson, AZ United States
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University of Arkansas for Medical Sciences
Little Rock, AR United States
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Sutter East Bay Hospitals
Berkeley, CA United States
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John Muir Health
Concord, CA United States
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Sutter Hematology and Oncology
Sacramento, CA United States
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Sharp Memorial Hospital
San Diego, CA United States
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Sansum Clinic
Santa Barbara, CA United States
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Rocky Mountain Cancer Centers, LLP [Boulder-COBO]
Boulder, CO United States
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VA Eastern Colorado
Denver, CO United States
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Colorado Cancer Research Program
Denver, CO United States
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Glenwood Springs, CO United States
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Danbury, CT United States
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Whittingham Cancer Center
Norwalk, CT United States
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Stamford, CT United States
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Yale University School of Medicine
Trumbull, CT United States
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Hematology and Oncology
Waterbury, CT United States
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Cancer Specialists, LLC dba Cancer Specialists of North Florida
Fleming Island, FL United States
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Florida Cancer Affiliates
New Port Richey, FL United States
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Sacred Heart Medical Oncology Group
Pensacola, FL United States
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Northwest Georgia Oncology Centers, PC
Marietta, GA United States
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Cancer Treatment Centers of America - Southeastern Regional Medical Center
Newnan, GA United States
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Alexian Brothers Hospital Network
Elk Grove Village, IL United States
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United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr
Hines, IL United States
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AMITA Health Cancer Institute & Outpatient Center
Hinsdale, IL United States
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Illinois Cancer Specialists
Niles, IL United States
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Oncology Specialists, PC
Park Ridge, IL United States
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American Health Network of Indiana, LLC
New Albany, IN United States
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Siouxland Hematology-Oncology Associates, LLP
Sioux City, IA United States
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University of Kansas Cancer Center
Fairway, KS United States
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Baptist Healthcare System, Inc.
Louisville, KY United States
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Maine General Medical Center
Waterville, ME United States
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Anne Arundel Medical Center
Annapolis, MD United States
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Greater Baltimore Medical Center
Baltimore, MD United States
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Associates of Oncology/Hematology, P.C.
Rockville, MD United States
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Trinity Health -Michigan, d/b/a Saint Joseph Mercy Health System
Ann Arbor, MI United States
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Sparrow Hospital and Health System
Lansing, MI United States
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Mayo Clinic
Rochester, MN United States
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Central Care Cancer Center
Bolivar, MO United States
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University of Missouri Health Care
Columbia, MO United States
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Saint Louis University Cancer Center
Saint Louis, MO United States
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Mercy Medical Research Institute
Springfield, MO United States
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Southeast Nebraska Cancer Center
Lincoln, NE United States
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Dartmouth Hitchcock Medical Center
Lebanon, NH United States
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Summit Medical Group Overlook Oncology Center
Berkeley Heights, NJ United States
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Veterans Affairs New Jersey Health Care System
East Orange, NJ United States
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Drs. Forte, Schleider, and Attas, P.A.
Englewood, NJ United States
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Regional Cancer Care Associates LLC
Mount Holly, NJ United States
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Saint Peter's University Hospital
New Brunswick, NJ United States
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Brookdale University Hospital and Medical Center
Brooklyn, NY United States
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Glens Falls, NY United States
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Broome Oncology, LLC
Johnson City, NY United States
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Clinical Research Alliance
Lake Success, NY United States
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Kinston, NC United States
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Rex Cancer Center
Raleigh, NC United States
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Aultman Hospital
Canton, OH United States
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Oncology Hematology Care, Inc.
Cincinnati, OH United States
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MetroHealth Medical Systems
Cleveland, OH United States
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Mid Ohio Oncology Hematology Inc
Columbus, OH United States
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Toledo Clinic Cancer Center
Toledo, OH United States
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Board of Regents of the University of Oklahoma
Oklahoma City, OK United States
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Willamette Valley Cancer Institute
Eugene, OR United States
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Medford, OR United States
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Greenville, SC United States
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Rapid City Regional Hospital
Rapid City, SD United States
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Avera Cancer Institute
Sioux Falls, SD United States
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Memphis, TN United States
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Texas Oncology, P.A.-Amarillo
Amarillo, TX United States
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Arlington Cancer Center
Arlington, TX United States
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Texas Oncology-Arlington South
Arlington, TX United States
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Texas Oncology
Dallas, TX United States
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Baylor College of Medicine
Houston, TX United States
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Houston, TX United States
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Houston, TX United States
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Plano, TX United States
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Round Rock, TX United States
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San Antonio, TX United States
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San Antonio, TX United States
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Temple, TX United States
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Tyler, TX United States
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Tyler, TX United States
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Webster, TX United States
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Salt Lake City, UT United States
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Rutland, VT United States
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Christiansburg, VA United States
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Fort Belvoir, VA United States
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Norfolk, VA United States
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Bellingham, WA United States
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Gig Harbor, WA United States
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Olympia, WA United States
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Vancouver, WA United States
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Walla Walla, WA United States
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Wenatchee, WA United States
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Morgantown, WV United States
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Milwaukee, WI United States
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Oconomowoc, WI United States
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Waukesha, WI United States
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Berlin, Germany
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Klinikum Bremen-Mitte
Bremen, Germany
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Centrum fur Hamatologie und Onkologie Bethanien
Frankfurt, Germany
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Onkologischisches Ambulanzzentrum Hannover
Hannover, Germany
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Gemeinschaftspraxis fur Hamatologie und Onkologie
Kassel, Germany
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Hamato-Onkologische Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck
Munchen, Germany
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Hamatologie und Onkologie
Ravensberg, Germany
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Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
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Praxis Internistischer Onkologie und Hamatologie Frechen
Frechen, Germany
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Potsdam, Germany
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Marburg, Germany
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Great Bend, KS United States
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Gemeinschaftspraxis fur Hamatologie und Onkologie
Köln, Germany
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Kliniken Maria Hilf GmbH
Mönchengladbach, Germany
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Gemeinschaftspraxis f r H matologie und Onkologie
Münster, Germany
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Hamatologisch-onkologische Schwerpunktpraxis
Würzburg, Germany
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