Last updated on August 2017

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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Rebecca Lopez, Sr Study Manager

Arizona Oncology
Tucson, AZ United States
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Rebecca Lopez, Sr Study Manager

University of Arkansas for Medical Sciences
Little Rock, AR United States
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Rebecca Lopez, Sr Study Manager

Sutter East Bay Hospitals
Berkeley, CA United States
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Rebecca Lopez, Sr Study Manager

John Muir Health
Concord, CA United States
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Rebecca Lopez, Sr Study Manager

Sutter Hematology and Oncology
Sacramento, CA United States
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Rebecca Lopez, Sr Study Manager

Sharp Memorial Hospital
San Diego, CA United States
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Rebecca Lopez, Sr Study Manager

Sansum Clinic
Santa Barbara, CA United States
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Rebecca Lopez, Sr Study Manager

Rocky Mountain Cancer Centers, LLP [Boulder-COBO]
Boulder, CO United States
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Rebecca Lopez, Sr Study Manager

VA Eastern Colorado
Denver, CO United States
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Rebecca Lopez, Sr Study Manager

Colorado Cancer Research Program
Denver, CO United States
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Rebecca Lopez, Sr Study Manager

VVH Cancer Center Valley View Hospital
Glenwood Springs, CO United States
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Rebecca Lopez, Sr Study Manager

Praxair Cancer Center Danbury
Danbury, CT United States
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Rebecca Lopez, Sr Study Manager

Whittingham Cancer Center
Norwalk, CT United States
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Hematology Oncology Associates, PC
Stamford, CT United States
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Rebecca Lopez, Sr Study Manager

Yale University School of Medicine
Trumbull, CT United States
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Rebecca Lopez, Sr Study Manager

Hematology and Oncology
Waterbury, CT United States
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Rebecca Lopez, Sr Study Manager

Cancer Specialists, LLC dba Cancer Specialists of North Florida
Fleming Island, FL United States
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Rebecca Lopez, Sr Study Manager

Florida Cancer Affiliates
New Port Richey, FL United States
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Rebecca Lopez, Sr Study Manager

Sacred Heart Medical Oncology Group
Pensacola, FL United States
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Rebecca Lopez, Sr Study Manager

Northwest Georgia Oncology Centers, PC
Marietta, GA United States
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Rebecca Lopez, Sr Study Manager

Cancer Treatment Centers of America - Southeastern Regional Medical Center
Newnan, GA United States
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Rebecca Lopez, Sr Study Manager

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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Rebecca Lopez, Sr Study Manager

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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Rebecca Lopez, Sr Study Manager

Siouxland Hematology-Oncology Associates, LLP
Sioux City, IA United States
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Rebecca Lopez, Sr Study Manager

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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Rebecca Lopez, Sr Study Manager

Maine General Medical Center
Waterville, ME United States
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Rebecca Lopez, Sr Study Manager

Anne Arundel Medical Center
Annapolis, MD United States
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Rebecca Lopez, Sr Study Manager

Greater Baltimore Medical Center
Baltimore, MD United States
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Rebecca Lopez, Sr Study Manager

Associates of Oncology/Hematology, P.C.
Rockville, MD United States
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Rebecca Lopez, Sr Study Manager

Trinity Health -Michigan, d/b/a Saint Joseph Mercy Health System
Ann Arbor, MI United States
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Rebecca Lopez, Sr Study Manager

Sparrow Hospital and Health System
Lansing, MI United States
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Rebecca Lopez, Sr Study Manager

Mayo Clinic
Rochester, MN United States
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Rebecca Lopez, Sr Study Manager

Central Care Cancer Center
Bolivar, MO United States
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Rebecca Lopez, Sr Study Manager

University of Missouri Health Care
Columbia, MO United States
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Rebecca Lopez, Sr Study Manager

Saint Louis University Cancer Center
Saint Louis, MO United States
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Rebecca Lopez, Sr Study Manager

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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Rebecca Lopez, Sr Study Manager

Summit Medical Group Overlook Oncology Center
Berkeley Heights, NJ United States
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Rebecca Lopez, Sr Study Manager

Veterans Affairs New Jersey Health Care System
East Orange, NJ United States
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Rebecca Lopez, Sr Study Manager

Drs. Forte, Schleider, and Attas, P.A.
Englewood, NJ United States
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Rebecca Lopez, Sr Study Manager

Regional Cancer Care Associates LLC
Mount Holly, NJ United States
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Rebecca Lopez, Sr Study Manager

Saint Peter's University Hospital
New Brunswick, NJ United States
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Rebecca Lopez, Sr Study Manager

Brookdale University Hospital and Medical Center
Brooklyn, NY United States
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Rebecca Lopez, Sr Study Manager

C.R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, NY United States
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Broome Oncology, LLC
Johnson City, NY United States
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Rebecca Lopez, Sr Study Manager

Clinical Research Alliance
Lake Success, NY United States
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Kinston Medical Specialists PA
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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Rebecca Lopez, Sr Study Manager

MetroHealth Medical Systems
Cleveland, OH United States
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Rebecca Lopez, Sr Study Manager

Mid Ohio Oncology Hematology Inc
Columbus, OH United States
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Rebecca Lopez, Sr Study Manager

Toledo Clinic Cancer Center
Toledo, OH United States
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Rebecca Lopez, Sr Study Manager

Board of Regents of the University of Oklahoma
Oklahoma City, OK United States
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Rebecca Lopez, Sr Study Manager

Willamette Valley Cancer Institute
Eugene, OR United States
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Rebecca Lopez, Sr Study Manager

Hematology Oncology Associates, P.C.
Medford, OR United States
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Rebecca Lopez, Sr Study Manager

Hematology and Oncology Associates of SC, LLC
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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Baptist Cancer Center
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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Michael Debakey VA Medical Center
Houston, TX United States
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Millenium Oncology
Houston, TX United States
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Texas Health Physicians Group
Plano, TX United States
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Texas Oncology Round Rock Cancer Center - Round Rock
Round Rock, TX United States
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Cancer Care Network of South Texas - SAT & BC
San Antonio, TX United States
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Cancer Care Centers of South Texas - HOAST
San Antonio, TX United States
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Central Texas Veterans Health Care System
Temple, TX United States
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Rebecca Lopez, Sr Study Manager

Tyler Hematology and Oncology
Tyler, TX United States
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Rebecca Lopez, Sr Study Manager

Texas Oncology, P.A. - Tyler
Tyler, TX United States
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Rebecca Lopez, Sr Study Manager

Texas Oncology, P.A. - Deke Slayton Cancer Center
Webster, TX United States
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Rebecca Lopez, Sr Study Manager

Utah Cancer Specialist
Salt Lake City, UT United States
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Rebecca Lopez, Sr Study Manager

University of Utah
Salt Lake City, UT United States
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Rebecca Lopez, Sr Study Manager

Rutland Regional Medical Center
Rutland, VT United States
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Rebecca Lopez, Sr Study Manager

Oncology and Hematology Associates of Southwest Virginia, Inc. - Market Street
Christiansburg, VA United States
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Rebecca Lopez, Sr Study Manager

Fort Belvoir Community Hospital
Fort Belvoir, VA United States
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Virginia Oncology Associates
Norfolk, VA United States
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Rebecca Lopez, Sr Study Manager

PeaceHealth St. Joseph Medical Center
Bellingham, WA United States
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Rebecca Lopez, Sr Study Manager

Northwest Medical Specialties PLLC
Gig Harbor, WA United States
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Rebecca Lopez, Sr Study Manager

Vista Oncology, Inc.
Olympia, WA United States
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Rebecca Lopez, Sr Study Manager

Northwest Cancer Specialists, P.C.
Vancouver, WA United States
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Rebecca Lopez, Sr Study Manager

Providence St. Mary Regional Cancer Center
Walla Walla, WA United States
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Rebecca Lopez, Sr Study Manager

Wenatchee Valley Hospital and Clinics
Wenatchee, WA United States
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Rebecca Lopez, Sr Study Manager

West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
Morgantown, WV United States
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Aurora Health Care Aurora Research
Milwaukee, WI United States
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DN Greenwald Center
Mukwonago, WI United States
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Oconomowoc Memorial Hospital
Oconomowoc, WI United States
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Waukesha Memorial Hospital
Waukesha, WI United States
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Onkologische Schwerpunktpraxis Kurfurstendamm
Berlin, Germany
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Rebecca Lopez, Sr Study Manager

Charite - Universitaetsmedizin Berlin Campus Virchow Klinikum
Berlin, Germany
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Klinikum Bremen-Mitte
Bremen, Germany
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Rebecca Lopez, Sr Study Manager

Centrum fur Hamatologie und Onkologie Bethanien
Frankfurt, Germany
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Rebecca Lopez, Sr Study Manager

Universitatsklinikum Giessen
Giessen, Germany
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Rebecca Lopez, Sr Study Manager

Onkologischisches Ambulanzzentrum Hannover
Hannover, Germany
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Rebecca Lopez, Sr Study Manager

Gemeinschaftspraxis fur Hamatologie und Onkologie
Kassel, Germany
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Hamato-Onkologische Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck
Munchen, Germany
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Rebecca Lopez, Sr Study Manager

Hamatologie und Onkologie
Ravensberg, Germany
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Rebecca Lopez, Sr Study Manager

Hamatologisch-onkologische Schwerpunktpraxis
Würzburg, Germany
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Rebecca Lopez, Sr Study Manager

Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
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