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 (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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

503

Study ID:

NCT01996865

Recruitment Status:

Active, not recruiting

Sponsor:

Celgene

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There are 123 Locations for this study

See Locations Near You

Local Institution - 055
Tucson Arizona, 85710, United States
Local Institution - 077
Little Rock Arkansas, 72205, United States
Local Institution - 079
Berkeley California, 94704, United States
John Muir Health
Concord California, 94520, United States
Bay Area Cancer Research Group, LLC
Pleasant Hill California, 94523, United States
Sutter Hematology and Oncology
Sacramento California, 95816, United States
Local Institution - 032
San Diego California, 92123, United States
Local Institution - 130
Santa Barbara California, 93105, United States
Local Institution - 052
Boulder Colorado, 80303, United States
Local Institution - 106
Denver Colorado, 80220, United States
Colorado Cancer Research Program
Denver Colorado, 80222, United States
Local Institution - 062
Glenwood Springs Colorado, 81601, United States
Praxair Cancer Center Danbury
Danbury Connecticut, 06810, United States
Medical Oncology and Blood Disorders, LLP
Manchester Connecticut, 06040, United States
Local Institution - 041
Norwalk Connecticut, 06851, United States
Hematology Oncology Associates, PC
Stamford Connecticut, 06902, United States
Local Institution - 149
Trumbull Connecticut, 06611, United States
Local Institution - 116
Waterbury Connecticut, 06701, United States
Cancer Specialists, LLC dba Cancer Specialists of North Florida
Fleming Island Florida, 32003, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach Florida, 33140, United States
Local Institution - 054
Ocala Florida, 34474, United States
Sacred Heart Medical Oncology Group
Pensacola Florida, 32504, United States
Local Institution - 011
Marietta Georgia, 30060, United States
Local Institution - 083
Newnan Georgia, 30265, United States
Local Institution - 108
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
Local Institution - 159
Hinsdale Illinois, 60521, United States
Local Institution - 056
Niles Illinois, 60714, United States
Local Institution - 028
Park Ridge Illinois, 60068, United States
Orchard Healthcare Research Inc.
Skokie Illinois, 60077, United States
American Health Network of Indiana, LLC
New Albany Indiana, 47150, United States
McFarland Clinic
Ames Iowa, 50010, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Cedar Valley Medical Specialists
Waterloo Iowa, 50701, United States
Local Institution - 019
Fairway Kansas, 66205, United States
Local Institution - 350
Great Bend Kansas, 67530, United States
Kentucky Cancer Clinic
Hazard Kentucky, 41701, United States
Local Institution - 138
Louisville Kentucky, 40207, United States
Maine General Medical Center
Waterville Maine, 04901, United States
Anne Arundel Medical Center
Annapolis Maryland, 21401, United States
Local Institution - 030
Baltimore Maryland, 21204, United States
Associates Of Oncology/Hematology, P.C.
Rockville Maryland, 20850, United States
Local Institution - 051
Ann Arbor Michigan, 48106, United States
Local Institution - 033
Lansing Michigan, 48912, United States
Local Institution - 164
Rochester Minnesota, 55905, United States
Local Institution - 050
Bolivar Missouri, 65613, United States
Local Institution - 103
Columbia Missouri, 65212, United States
Local Institution - 042
Saint Louis Missouri, 63110, United States
Mercy Medical Research Institute
Springfield Missouri, 65804, United States
Local Institution - 003
Lincoln Nebraska, 68510, 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
Local Institution - 080
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
Local Institution - 152
Lake Success New York, 11042, United States
Local Institution - 023
Kinston North Carolina, 28501, United States
Local Institution - 039
Raleigh North Carolina, 27607, United States
Summa Health System Akron City Hospital Laboratory
Akron Ohio, 44202, United States
Aultman Hospital
Canton Ohio, 44710, United States
Local Institution - 161
Cincinnati Ohio, 45242, United States
Local Institution - 047
Cleveland Ohio, 44109, United States
Local Institution - 045
Columbus Ohio, 43219, United States
Toledo Clinic Cancer Center
Toledo Ohio, 43623, United States
Local Institution - 037
Oklahoma City Oklahoma, 73104, United States
Local Institution - 059
Eugene Oregon, 97401, United States
Hematology Oncology Associates, P.C.
Medford Oregon, 97504, United States
Local Institution - 073
Greenville South Carolina, 29615, United States
Spartanburg Regional Healthcare System - Gibbs Cancer Center & Research Institute
Spartanburg South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Local Institution - 153
Sioux Falls South Dakota, 57105, United States
Baptist Cancer Center
Memphis Tennessee, 38104, United States
Local Institution - 076
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
Local Institution - 105
Dallas Texas, 75230, United States
Local Institution - 026
Houston Texas, 77030, United States
Local Institution - 067
Houston Texas, 77030, United States
Local Institution - 008
Houston Texas, 77090, United States
Texas Health Physicians Group
Plano Texas, 75093, United States
Local Institution - 071
Round Rock Texas, 78681, United States
Local Institution - 070
San Antonio Texas, 78217, United States
Local Institution - 058
San Antonio Texas, 78240, United States
Local Institution - 111
Temple Texas, 66205, United States
Tyler Hematology and Oncology
Tyler Texas, 75701, United States
Local Institution - 163
Tyler Texas, 75702, United States
Texas Oncology, P.A. - Deke Slayton Cancer Center
Webster Texas, 77598, United States
Local Institution - 090
Salt Lake City Utah, 84106, United States
Rutland Regional Medical Center
Rutland Vermont, 05701, United States
Local Institution - 053
Christiansburg Virginia, 24073, United States
Fort Belvoir Community Hospital
Fort Belvoir Virginia, 22060, United States
Local Institution - 081
Norfolk Virginia, 23502, United States
Cancer Treatment Center of America
Portsmouth Virginia, 23704, United States
PeaceHealth St. Joseph Medical Center
Bellingham Washington, 98225, United States
Local Institution - 049
Gig Harbor Washington, 98332, United States
Local Institution - 119
Olympia Washington, 98502, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Local Institution - 104
Vancouver Washington, 98684, United States
Local Institution - 099
Walla Walla Washington, 99362, United States
Local Institution - 006
Wenatchee Washington, 98801, United States
Local Institution - 038
Morgantown West Virginia, 26506, United States
Aurora Health Care Aurora Research
Milwaukee Wisconsin, 53233, United States
Local Institution - 301
Mukwonago Wisconsin, 53145, United States
Local Institution - 300
Oconomowoc Wisconsin, 53066, United States
Local Institution - 101
Waukesha Wisconsin, 53188, United States
Local Institution - 208
Berlin , 10707, Germany
Local Institution - 202
Bremen , 28177, Germany
Local Institution - 205
Frankfurt , 60389, Germany
Local Institution - 211
Frechen , 50226, Germany
Local Institution - 200
Gießen , 35392, Germany
Local Institution - 203
Hannover , 30171, Germany
Local Institution - 206
Kassel , 34119, Germany
Local Institution - 213
Köln , 50677, Germany
Local Institution - 210
Marburg , 35037, Germany
Local Institution - 204
Munchen , 81241, Germany
Local Institution - 215
Mönchengladbach , 41063, Germany
Local Institution - 212
Münster , 48149, Germany
Local Institution - 201
Potsdam , 14467, Germany
Local Institution - 207
Ravensberg , 88212, Germany
Local Institution - 209
Würzburg , 97080, Germany
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?

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