Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
18 Years and older, Male and Female
CC-5013-NHL-008 (primary)
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.
Objectives
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
- 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
Treatment Sites in Georgia
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