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.
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.
Eligibility Criteria
Inclusion Criteria:
-- Age ≥18 years
Histologically confirmed Follicular Lymphoma (FL, Grade 1, 2, 3a, or 3b), Transformed FL, 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 4 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
Other protocol-defined inclusion/exclusion criteria apply
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 112 Locations for this study
Tucson Arizona, 85710, United States
Little Rock Arkansas, 72205, United States
Berkeley California, 94704, United States
Concord California, 94520, United States
Sacramento California, 95816, United States
San Diego California, 92123, United States
Santa Barbara California, 93105, United States
Boulder Colorado, 80303, United States
Denver Colorado, 80220, United States
Denver Colorado, 80222, United States
Glenwood Springs Colorado, 81601, United States
Danbury Connecticut, 06810, United States
Norwalk Connecticut, 06851, United States
Stamford Connecticut, 06902, United States
Trumbull Connecticut, 06611, United States
Waterbury Connecticut, 06701, United States
Fleming Island Florida, 32003, United States
Ocala Florida, 34474, United States
Pensacola Florida, 32504, United States
Marietta Georgia, 30060, United States
Newnan Georgia, 30265, United States
Elk Grove Village Illinois, 60007, United States
Hines Illinois, 60141, United States
Hinsdale Illinois, 60521, United States
Niles Illinois, 60714, United States
Park Ridge Illinois, 60068, United States
New Albany Indiana, 47150, United States
Sioux City Iowa, 51101, United States
Fairway Kansas, 66205, United States
Great Bend Kansas, 67530, United States
Louisville Kentucky, 40207, United States
Waterville Maine, 04901, United States
Annapolis Maryland, 21401, United States
Baltimore Maryland, 21204, United States
Rockville Maryland, 20850, United States
Ann Arbor Michigan, 48106, United States
Lansing Michigan, 48912, United States
Rochester Minnesota, 55905, United States
Bolivar Missouri, 65613, United States
Columbia Missouri, 65212, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Lincoln Nebraska, 68510, United States
Lebanon New Hampshire, 03756, United States
Berkeley Heights New Jersey, 07922, United States
East Orange New Jersey, 07018, United States
Englewood New Jersey, 07631, United States
Mount Holly New Jersey, 08060, United States
New Brunswick New Jersey, 08901, United States
Brooklyn New York, 11212, United States
Glens Falls New York, 12801, United States
Johnson City New York, 13790, United States
Lake Success New York, 11042, United States
Kinston North Carolina, 28501, United States
Raleigh North Carolina, 27607, United States
Canton Ohio, 44710, United States
Cincinnati Ohio, 45242, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43219, United States
Toledo Ohio, 43623, United States
Oklahoma City Oklahoma, 73104, United States
Eugene Oregon, 97401, United States
Medford Oregon, 97504, United States
Greenville South Carolina, 29615, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57105, United States
Memphis Tennessee, 38104, United States
Memphis Tennessee, 38104, United States
Amarillo Texas, 79106, United States
Arlington Texas, 76012, United States
Arlington Texas, 76014, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
Plano Texas, 75093, United States
Round Rock Texas, 78681, United States
San Antonio Texas, 78217, United States
San Antonio Texas, 78240, United States
Temple Texas, 66205, United States
Tyler Texas, 75701, United States
Tyler Texas, 75702, United States
Webster Texas, 77598, United States
Salt Lake City Utah, 84106, United States
Rutland Vermont, 05701, United States
Christiansburg Virginia, 24073, United States
Fort Belvoir Virginia, 22060, United States
Norfolk Virginia, 23502, United States
Bellingham Washington, 98225, United States
Gig Harbor Washington, 98332, United States
Olympia Washington, 98502, United States
Vancouver Washington, 98684, United States
Walla Walla Washington, 99362, United States
Wenatchee Washington, 98801, United States
Morgantown West Virginia, 26506, United States
Milwaukee Wisconsin, 53233, United States
Mukwonago Wisconsin, 53145, United States
Oconomowoc Wisconsin, 53066, United States
Waukesha Wisconsin, 53188, United States
Berlin , 10707, Germany
Bremen , 28177, Germany
Frankfurt , 60389, Germany
Frechen , 50226, Germany
Gießen , 35392, Germany
Hannover , 30171, Germany
Kassel , 34119, Germany
Köln , 50677, Germany
Marburg , 35037, Germany
Munchen , 81241, Germany
Mönchengladbach , 41063, Germany
Münster , 48149, Germany
Potsdam , 14467, Germany
Ravensberg , 88212, Germany
Würzburg , 97080, Germany
San Juan , 00919, Puerto Rico
How clear is this clinincal trial information?