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



Status:Recruiting
Conditions:Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/14/2019
Start Date:April 2, 2014
End Date:July 8, 2024
Contact:Caroline Labe, Clinical Trial Manager
Email:clabe@celgene.com
Phone:617-710-7065

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A Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single-Agent Maintenance Versus Rituximab in Subjects With Relapsed/Refractory Follicular, Marginal Zone, or Mantle Cell Lymphoma

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.

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.

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.
We found this trial at
100
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
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1200 Moursund Street
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(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Amarillo, Texas 79106
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Annapolis, Maryland 21401
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Arlington, Texas 76012
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
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Bellingham, Washington 98225
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Berkeley, California 94704
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Berkeley Heights, New Jersey 07922
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64-65 Kurfürstendamm
Berlin, 10707
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Bolivar, Missouri 65613
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Canton, Ohio 44710
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5053 Wooster Rd
Cincinnati, Ohio 45226
(513) 751-2273
Oncology Hematology Care Our more than 60 physicians and advanced practice providers throughout neighborhood offices...
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Cleveland, Ohio 44109
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Concord, California 94520
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24 Hospital Avenue
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520 Country Club Road
Eugene, Oregon 97401
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1 Salt Creek Lane
Hinsdale, Illinois 60521
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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254 Easton Ave
New Brunswick, New Jersey 08901
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5900 Lake Wright Dr
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Raleigh, North Carolina 27609
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
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1020 29th Street
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San Antonio, Texas 78229
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7901 Frost Street
San Diego, California 92123
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Santa Barbara, California 93105
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230 Nebraska St.
Sioux City, Iowa 51101
712-252-0088
Siouxland Hematology-Oncology Associates, LLP Siouxland Hematology-Oncology Associates (SHOA) provides medical oncology treatment. In addition to...
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