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

Completed · Phase 3

Conditions studied: Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT01996865

Run by

Celgene

People needed

503

Starts

2014-04-01

Expected to finish

2024-09-17

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• - 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 077 — Little Rock, Arkansas, United States
• Local Institution - 079 — Berkeley, California, United States
• Local Institution - 142 — Concord, California, United States
• Bay Area Cancer Research Group, LLC — Pleasant Hill, California, United States
• Sutter Hematology and Oncology — Sacramento, California, United States
• Local Institution - 032 — San Diego, California, United States
• Local Institution - 130 — Santa Barbara, California, United States
• Local Institution - 052 — Boulder, Colorado, United States
• Local Institution - 106 — Denver, Colorado, United States
• Colorado Cancer Research Program — Denver, Colorado, United States
• Local Institution - 062 — Glenwood Springs, Colorado, United States
• Praxair Cancer Center Danbury — Danbury, Connecticut, United States
• Medical Oncology and Blood Disorders, LLP — Manchester, Connecticut, United States
• Local Institution - 041 — Norwalk, Connecticut, United States
• Hematology Oncology Associates, PC — Stamford, Connecticut, United States
• Local Institution - 149 — Trumbull, Connecticut, United States
• Local Institution - 116 — Waterbury, Connecticut, United States
• Local Institution - 068 — Fleming Island, Florida, United States
• Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States
• Local Institution - 054 — Ocala, Florida, United States
• Local Institution - 114 — Pensacola, Florida, United States
• Local Institution - 011 — Marietta, Georgia, United States
• Local Institution - 083 — Newnan, Georgia, United States
• Local Institution - 108 — Elk Grove Village, Illinois, United States
• Local Institution - 055 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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