Skip to main content

COVID-19 is an emerging, rapidly evolving situation.

What people with cancer should know: https://www.cancer.gov/coronavirus

Get the latest public health information from CDC: https://www.coronavirus.gov

Get the latest research information from NIH: https://www.nih.gov/coronavirus

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

Trial Status: Closed to Accrual

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.

Inclusion 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.

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL
Contact: Laura Leary
Phone: 203-800-1969

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: WITHDRAWN

Kansas

Kansas City
University of Kansas Cancer Center
Status: CLOSED_TO_ACCRUAL
University of Kansas Cancer Center-West
Status: CLOSED_TO_ACCRUAL
Overland Park
University of Kansas Cancer Center-Overland Park
Status: CLOSED_TO_ACCRUAL
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: CLOSED_TO_ACCRUAL

Minnesota

Rochester
Mayo Clinic
Status: CLOSED_TO_ACCRUAL

Missouri

Kansas City
The University of Kansas Cancer Center-North
Status: CLOSED_TO_ACCRUAL
The University of Kansas Cancer Center-South
Status: CLOSED_TO_ACCRUAL
Lee's Summit
The University of Kansas Cancer Center-Lee's Summit
Status: CLOSED_TO_ACCRUAL

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: CLOSED_TO_ACCRUAL

Texas

Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Ben Taub General Hospital
Status: CLOSED_TO_ACCRUAL
Michael E DeBakey VA Medical Center
Status: CLOSED_TO_ACCRUAL

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.

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Celgene

  • Primary ID CC-5013-NHL-008
  • Secondary IDs NCI-2015-00708
  • Clinicaltrials.gov ID NCT01996865