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

Status
Closed
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase III
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT01996865
Protocol IDs
CC-5013-NHL-008 (primary)
Study Sponsor
Celgene

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

  1. 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

Northwest Georgia Oncology Centers - Austell


1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen


200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton


157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville


100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville


6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Navin P. Wadehra MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Jasper


1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Paulding


144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica


705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Study Coordinator:
Mary Gilley
770-281-5131

Doctors:

Randall E. Pierce MD
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