Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

503

Study ID:

NCT01996865

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 113 Locations for this study

See Locations Near You

Arizona Oncology
Tucson Arizona, 85710, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Sutter East Bay Hospitals
Berkeley California, 94704, United States
John Muir Health
Concord California, 94520, United States
Sutter Hematology and Oncology
Sacramento California, 95816, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Sansum Clinic
Santa Barbara California, 93105, United States
Rocky Mountain Cancer Centers, LLP [Boulder-COBO]
Boulder Colorado, 80303, United States
VA Eastern Colorado
Denver Colorado, 80220, United States
Colorado Cancer Research Program
Denver Colorado, 80222, United States
VVH Cancer Center Valley View Hospital
Glenwood Springs Colorado, 81601, United States
Praxair Cancer Center Danbury
Danbury Connecticut, 06810, United States
Local Institution - 041
Norwalk Connecticut, 06851, United States
Whittingham Cancer Center
Norwalk Connecticut, 06851, United States
Hematology Oncology Associates, PC
Stamford Connecticut, 06902, United States
Yale University School of Medicine
Trumbull Connecticut, 06611, United States
Hematology and Oncology
Waterbury Connecticut, 06701, United States
Cancer Specialists, LLC dba Cancer Specialists of North Florida
Fleming Island Florida, 32003, United States
Florida Cancer Affiliates
New Port Richey Florida, 34655, United States
Local Institution - 054
Ocala Florida, 34474, United States
Sacred Heart Medical Oncology Group
Pensacola Florida, 32504, United States
Northwest Georgia Oncology Centers, PC
Marietta Georgia, 30060, United States
Cancer Treatment Centers of America - Southeastern Regional Medical Center
Newnan Georgia, 30265, United States
Alexian Brothers Hospital Network
Elk Grove Village Illinois, 60007, United States
United States Department of Veterans Affairs - VA Great Lakes Health Care System - Edward Hines Jr
Hines Illinois, 60141, United States
AMITA Health Cancer Institute & Outpatient Center
Hinsdale Illinois, 60521, United States
Illinois Cancer Specialists
Niles Illinois, 60714, United States
Local Institution - 056
Niles Illinois, 60714, United States
Local Institution - 028
Park Ridge Illinois, 60068, United States
Oncology Specialists, PC
Park Ridge Illinois, 60068, United States
American Health Network of Indiana, LLC
New Albany Indiana, 47150, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Local Institution - 019
Fairway Kansas, 66205, United States
University of Kansas Cancer Center
Fairway Kansas, 66205, United States
CentralCare Cancer Center
Great Bend Kansas, 67530, United States
Baptist Healthcare System, Inc.
Louisville Kentucky, 40207, United States
Maine General Medical Center
Waterville Maine, 04901, United States
Anne Arundel Medical Center
Annapolis Maryland, 21401, United States
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States
Associates of Oncology/Hematology, P.C.
Rockville Maryland, 20850, United States
Trinity Health -Michigan, d/b/a Saint Joseph Mercy Health System
Ann Arbor Michigan, 48106, United States
Sparrow Hospital and Health System
Lansing Michigan, 48912, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Central Care Cancer Center
Bolivar Missouri, 65613, United States
Local Institution - 050
Bolivar Missouri, 65613, United States
University of Missouri Health Care
Columbia Missouri, 65212, United States
Saint Louis University Cancer Center
Saint Louis Missouri, 63110, United States
Mercy Medical Research Institute
Springfield Missouri, 65804, United States
Southeast Nebraska Cancer Center
Lincoln Nebraska, 68510, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Local Institution - 098
Lebanon New Hampshire, 03756, United States
Summit Medical Group Overlook Oncology Center
Berkeley Heights New Jersey, 07922, United States
Veterans Affairs New Jersey Health Care System
East Orange New Jersey, 07018, United States
Drs. Forte, Schleider, and Attas, P.A.
Englewood New Jersey, 07631, United States
Regional Cancer Care Associates LLC
Mount Holly New Jersey, 08060, United States
Saint Peter's University Hospital
New Brunswick New Jersey, 08901, United States
Brookdale University Hospital and Medical Center
Brooklyn New York, 11212, United States
C.R. Wood Cancer Center at Glens Falls Hospital
Glens Falls New York, 12801, United States
Broome Oncology, LLC
Johnson City New York, 13790, United States
Clinical Research Alliance
Lake Success New York, 11042, United States
Kinston Medical Specialists PA
Kinston North Carolina, 28501, United States
Rex Cancer Center
Raleigh North Carolina, 27607, United States
Aultman Hospital
Canton Ohio, 44710, United States
Oncology Hematology Care, Inc.
Cincinnati Ohio, 45242, United States
Local Institution - 047
Cleveland Ohio, 44109, United States
MetroHealth Medical Systems
Cleveland Ohio, 44109, United States
Mid Ohio Oncology Hematology Inc
Columbus Ohio, 43219, United States
Toledo Clinic Cancer Center
Toledo Ohio, 43623, United States
Board of Regents of the University of Oklahoma
Oklahoma City Oklahoma, 73104, United States
Local Institution - 037
Oklahoma City Oklahoma, 73104, United States
Local Institution - 059
Eugene Oregon, 97401, United States
Willamette Valley Cancer Institute
Eugene Oregon, 97401, United States
Hematology Oncology Associates, P.C.
Medford Oregon, 97504, United States
Hematology and Oncology Associates of SC, LLC
Greenville South Carolina, 29615, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Baptist Cancer Center
Memphis Tennessee, 38104, United States
Texas Oncology, P.A.-Amarillo
Amarillo Texas, 79106, United States
Arlington Cancer Center
Arlington Texas, 76012, United States
Texas Oncology-Arlington South
Arlington Texas, 76014, United States
Texas Oncology
Dallas Texas, 75230, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Local Institution - 026
Houston Texas, 77030, United States
Local Institution - 067
Houston Texas, 77030, United States
Michael Debakey VA Medical Center
Houston Texas, 77030, United States
Local Institution - 008
Houston Texas, 77090, United States
Millenium Oncology
Houston Texas, 77090, United States
Texas Health Physicians Group
Plano Texas, 75093, United States
Texas Oncology Round Rock Cancer Center - Round Rock
Round Rock Texas, 78681, United States
Cancer Care Network of South Texas - SAT & BC
San Antonio Texas, 78217, United States
Cancer Care Centers of South Texas - HOAST
San Antonio Texas, 78240, United States
Central Texas Veterans Health Care System
Temple Texas, 66205, United States
Tyler Hematology and Oncology
Tyler Texas, 75701, United States
Texas Oncology, P.A. - Tyler
Tyler Texas, 75702, United States
Texas Oncology, P.A. - Deke Slayton Cancer Center
Webster Texas, 77598, United States
Utah Cancer Specialist
Salt Lake City Utah, 84106, United States
Rutland Regional Medical Center
Rutland Vermont, 05701, United States
Local Institution - 053
Christiansburg Virginia, 24073, United States
Oncology and Hematology Associates of Southwest Virginia, Inc. - Market Street
Christiansburg Virginia, 24073, United States
Fort Belvoir Community Hospital
Fort Belvoir Virginia, 22060, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
PeaceHealth St. Joseph Medical Center
Bellingham Washington, 98225, United States
Northwest Medical Specialties PLLC
Gig Harbor Washington, 98332, United States
Vista Oncology, Inc.
Olympia Washington, 98502, United States
Local Institution - 104
Vancouver Washington, 98684, United States
Northwest Cancer Specialists, P.C.
Vancouver Washington, 98684, United States
Providence St. Mary Regional Cancer Center
Walla Walla Washington, 99362, United States
Wenatchee Valley Hospital and Clinics
Wenatchee Washington, 98801, United States
West Virginia University, Berkeley Medical Center, Cancer and Infusion Center
Morgantown West Virginia, 26506, United States
Aurora Health Care Aurora Research
Milwaukee Wisconsin, 53233, United States
DN Greenwald Center
Mukwonago Wisconsin, 53145, United States
Oconomowoc Memorial Hospital
Oconomowoc Wisconsin, 53066, United States
Waukesha Memorial Hospital
Waukesha Wisconsin, 53188, United States
Onkologische Schwerpunktpraxis Kurfurstendamm
Berlin , 10707, Germany
Klinikum Bremen-Mitte
Bremen , 28177, Germany
Centrum fur Hamatologie und Onkologie Bethanien
Frankfurt , 60389, Germany
Praxis Internistischer Onkologie und Hamatologie Frechen
Frechen , 50226, Germany
Local Institution - 200
Gießen , 35392, Germany
Onkologischisches Ambulanzzentrum Hannover
Hannover , 30171, Germany
Gemeinschaftspraxis fur Hamatologie und Onkologie
Kassel , 34119, Germany
Local Institution - 206
Kassel , 34119, Germany
Gemeinschaftspraxis fur Hamatologie und Onkologie
Köln , 50677, Germany
OnkoNet Marburg GmbH
Marburg , 35037, Germany
Hamato-Onkologische Uberortliche Gemeinschaftspraxis Pasing und Furstenfeldbruck
Munchen , 81241, Germany
Kliniken Maria Hilf GmbH
Mönchengladbach , 41063, Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Münster , 48149, Germany
Klinikum Ernst von Bergmann gGmbH
Potsdam , 14467, Germany
Hamatologie und Onkologie
Ravensberg , 88212, Germany
Hamatologisch-onkologische Schwerpunktpraxis
Würzburg , 97080, Germany
Local Institution - 209
Würzburg , 97080, Germany
Auxilio Mutuo Cancer Center
San Juan , 00919, Puerto Rico
Local Institution - 029
San Juan , 00919, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

503

Study ID:

NCT01996865

Recruitment Status:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.