Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • - Age ≥18 years
  • Histologically confirmed Follicular Lymphoma (Grade 1, 2 or 3a), Marginal Zone Lymphoma, or Mantle Cell Lymphoma
  • Must have documented relapsed, refractory or Progressive Disease after last treatment with systemic therapy
  • Bi-dimensionally measurable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
  • Adequate bone marrow function
  • Willingness to follow pregnancy precautions

Exclusion Criteria

  • Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma
  • Any medical condition (other than the underlying lymphoma) that requires chronic steroid use
  • Subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
  • Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months
  • Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
  • Known sensitivity or allergy to murine products
  • Presence or history of central nervous system involvement by lymphoma. Subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
  • Any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Lenalidomide + rituximab followed by lenalidomide
Induction Period (12 cycles): Lenalidomide 20mg (10 mg if creatinine clearance ≥ 30 mL/min but < 60mL/min) by mouth (PO) daily (QD) on Days 1 to 21 of every 28-day cycle during cycles 1 through 12 and rituximab 375mg/m^2 intraveneously (IV) every week in Cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period (lasting 18 Cycles) that includes Lenalidomide 10 mg PO QD on Days 1 to 21 of every 28-day cycle during cycles 13 to 30 and rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29 followed by a Maintenance Period (up to Progressive Disease) receiving Lenalidomide 10mg PO QD on Days 1 through 21 of every 28 day cycle until the disease progresses
  • Drug: Lenalidomide
    Other names:
    • CC-5013, Revlimid
  • Drug: Rituximab
    Other names:
    • Rituxan
Active Comparator
Arm B: Lenalidomide + rituximab followed by rituximab
Induction Period (12 Cycles): Lenalidomide 20 mg PO QD (10 mg if creatinine clearance ≥ 30 mL/min but < 60 mL/min) on Days 1 to 21 of every 28-day cycle during cycles 1 to 12 and rituximab 375 mg/m^2 IV every week in cycle 1 on Days 1, 8, 15, and 22 and on Day 1 of every 28-day cycle during cycles 3, 5, 7, 9, and 11, followed by a Maintenance Period for 18 Cycles that includes: Rituximab 375 mg/m^2 IV on Day 1 of every 28-day cycle during cycles 13, 15, 17, 19, 21, 23, 25, 27, and 29
  • Drug: Lenalidomide
    Other names:
    • CC-5013, Revlimid
  • Drug: Rituximab
    Other names:
    • Rituxan

Recruiting Locations

Arizona Oncology
Tucson, Arizona 85710

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205

Sutter East Bay Hospitals
Berkeley, California 94704

John Muir Health
Concord, California 94520

Sharp Memorial Hospital
San Diego, California 92123

Sansum Clinic
Santa Barbara, California 93105

Rocky Mountain Cancer Centers, LLP [Boulder-COBO]
Boulder, Colorado 80303

VA Eastern Colorado
Denver, Colorado 80220

VVH Cancer Center Valley View Hospital
Glenwood Springs, Colorado 81601

Praxair Cancer Center Danbury
Danbury, Connecticut 06810

Whittingham Cancer Center
Norwalk, Connecticut 06851

Yale University School of Medicine
Trumbull, Connecticut 06611

Hematology and Oncology
Waterbury, Connecticut 067014

Florida Cancer Affiliates
New Port Richey, Florida 34655

Sacred Heart Medical Oncology Group
Pensacola, Florida 32504

Northwest Georgia Oncology Centers, PC
Marietta, Georgia 30060

Cancer Treatment Centers of America - Southeastern Regional Medical Center
Newnan, Georgia 30265

Alexian Brothers Hospital Network
Elk Grove Village, Illinois 60007

AMITA Health Cancer Institute & Outpatient Center
Hinsdale, Illinois 60521

Illinois Cancer Specialists
Niles, Illinois 60714

Oncology Specialists, PC
Park Ridge, Illinois 60068

University of Kansas Cancer Center
Fairway, Kansas 66205

CentralCare Cancer Center
Great Bend, Kansas 67530

Baptist Healthcare System, Inc.
Louisville, Kentucky 40207

Maine General Medical Center
Waterville, Maine 04901

Anne Arundel Medical Center
Annapolis, Maryland 21401

Greater Baltimore Medical Center
Baltimore, Maryland 21204

Trinity Health -Michigan, d/b/a Saint Joseph Mercy Health System
Ann Arbor, Michigan 48106

Sparrow Hospital and Health System
Lansing, Michigan 48912

Mayo Clinic
Rochester, Minnesota 55905

Central Care Cancer Center
Bolivar, Missouri 65613

University of Missouri Health Care
Columbia, Missouri 65212

Saint Louis University Cancer Center
Saint Louis, Missouri 63110

Southeast Nebraska Cancer Center
Lincoln, Nebraska 68510

Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 03756

Veterans Affairs New Jersey Health Care System
East Orange, New Jersey 07018

Drs. Forte, Schleider, and Attas, P.A.
Englewood, New Jersey 07631

Saint Peter's University Hospital
New Brunswick, New Jersey 08901

C.R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York 12801

Clinical Research Alliance
Lake Success, New York 11042

Kinston Medical Specialists PA
Kinston, North Carolina 28501-1584

Rex Cancer Center
Raleigh, North Carolina 27607

Oncology Hematology Care, Inc.
Cincinnati, Ohio 45242

MetroHealth Medical Systems
Cleveland, Ohio 44109

Mid Ohio Oncology Hematology Inc
Columbus, Ohio 43219

Toledo Clinic Cancer Center
Toledo, Ohio 43623

Board of Regents of the University of Oklahoma
Oklahoma City, Oklahoma 73104

Willamette Valley Cancer Institute
Eugene, Oregon 97401

Hematology Oncology Associates, P.C.
Medford, Oregon 97504

Hematology and Oncology Associates of SC, LLC
Greenville, South Carolina 29615

Rapid City Regional Hospital
Rapid City, South Dakota 57701

Avera Cancer Institute
Sioux Falls, South Dakota 57105

Baptist Cancer Center
Memphis, Tennessee 38104

Texas Oncology, P.A.-Amarillo
Amarillo, Texas 79106

Texas Oncology
Dallas, Texas 75230

Baylor College of Medicine
Houston, Texas 77030

Michael Debakey VA Medical Center
Houston, Texas 77030

Millenium Oncology
Houston, Texas 77090

Texas Health Physicians Group
Plano, Texas 75093

Texas Oncology Round Rock Cancer Center - Round Rock
Round Rock, Texas 78681

Cancer Care Network of South Texas - SAT & BC
San Antonio, Texas 78217

Cancer Care Centers of South Texas - HOAST
San Antonio, Texas 78240

Central Texas Veterans Health Care System
Temple, Texas 66205

Tyler Hematology and Oncology
Tyler, Texas 75701

Texas Oncology, P.A. - Tyler
Tyler, Texas 75702

Texas Oncology, P.A. - Deke Slayton Cancer Center
Webster, Texas 77598-4420

Utah Cancer Specialist
Salt Lake City, Utah 84106

Oncology and Hematology Associates of Southwest Virginia, Inc. - Market Street
Christiansburg, Virginia 24073

Fort Belvoir Community Hospital
Fort Belvoir, Virginia 22060

Virginia Oncology Associates
Norfolk, Virginia 23502

Northwest Medical Specialties PLLC
Gig Harbor, Washington 98332

Vista Oncology, Inc.
Olympia, Washington 98502

Northwest Cancer Specialists, P.C.
Vancouver, Washington 98684

Providence St. Mary Regional Cancer Center
Walla Walla, Washington 99362

Wenatchee Valley Hospital and Clinics
Wenatchee, Washington 98801

West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
Morgantown, West Virginia 26506

DN Greenwald Center
Mukwonago, Wisconsin 53145

Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066

Waukesha Memorial Hospital
Waukesha, Wisconsin 53188-5099

Auxilio Mutuo Cancer Center
San Juan, Puerto Rico 00919-1227

More Details

NCT ID
NCT01996865
Status
Recruiting
Sponsor
Celgene

Study Contact

Caroline Labe, Clinical Trial Manager
617-710-7065
clabe@celgene.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.