Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)

Completed · Phase 3 · Has a placebo group

Conditions studied: Lymphoma, Non-Hodgkin

In brief

This double-blind randomized, parallel group study will evaluate the efficacy and safety of lenalidomide (Revlimid, CC-5013) in combination with rituximab (MabThera/Rituxan) in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma. Patients will be randomized to receive either lenalidomide or placebo for twelve 28-day cycles in combination with rituximab. Anticipated time on study treatment is 1 year.

Key facts

Study ID

NCT01938001

Run by

Celgene

People needed

358

Starts

2013-11-21

Expected to finish

2022-01-26

Last updated by the study team

2023-02-22

Who can join

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

You may qualify if…

• Age ≥18 years at the time of signing the informed consent document.
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
• Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry).
• Previously treated with at least one prior systemic chemotherapy, immunotherapy or chemoimmunotherapy and have received at least 2 previous doses of rituximab.
• Documented relapsed, refractory or progressive disease after treatment with systemic therapy and must not be rituximab-refractory.
• Investigator considers rituximab monotherapy appropriate.
• Bi-dimensionally measurable disease on cross sectional imaging by X-ray computed tomography (CT) or magnetic resonance imaging (MRI).
• Need of treatment for relapsed, progressed or refractory disease as assessed by the investigator.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Adequate bone marrow function.
• Willingness to follow study visit schedule, pregnancy precautions and other protocol requirements.

You may not qualify if…

• Histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or Grade 3b follicular lymphoma.
• Subjects taking corticosteroids during the last week prior to study treatment, unless administered at a dose equivalent to < 20 mg/day prednisone or prednisolone.
• Systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 6 months.
• Known seropositive for or active viral infection with hepatitis B virus (HBV) or/and human immunodeficiency virus (HIV).
• Known hepatitis C virus (HCV) positive with chronic HCV or active viral infection with HCV hepatitis requiring anti-viral medication (at time of randomization).
• Life expectancy < 6 months.
• Known sensitivity or allergy to murine products.
• Prior history of malignancies, other than follicular or marginal zone lymphoma, unless the subject has been free of the disease for ≥ 5 years.
• Prior use of lenalidomide.
• Known allergy to thalidomide.
• Neuropathy > Grade 1.
• 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.
• Uncontrolled intercurrent illness.
• Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent document.
• Pregnant or lactating females.
• 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.

Where it is running

• Arizona Center for Cancer Care — Glendale, Arizona, United States
• Southwest Cancer Care Medical Group — Escondido, California, United States
• Marin Oncology Associates — Greenbrae, California, United States
• Wilshire Oncology Medical Group, Inc — La Verne, California, United States
• North County Hematology Oncology (NCHO) - TRM, LLC. — Oceanside, California, United States
• Hematology-Oncology Medical Group of Orange County, Inc. — Orange, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Central Coast Medical Oncology Corporation — Santa Maria, California, United States
• Wellness Hematology Oncology — West Hills, California, United States
• Cancer Center of Central Connecticut — Southington, Connecticut, United States
• Florida Cancer Specialists North Region Sarah Cannon Research — St. Petersburg, Florida, United States
• Illinois Cancer Care, P.C. — Peoria, Illinois, United States
• LRG Healthcare Oncology Clinic — Laconia, Indiana, United States
• Iowa Oncology Research Association — Des Moines, Iowa, United States
• University of Louisville, J.G. Brown Cancer Center — Louisville, Kentucky, United States
• Providence Cancer Institute — Southfield, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Coborn Cancer Center at the St. Cloud Hospital — Saint Cloud, Minnesota, United States
• NH Oncology - Hematology, PA — Hooksett, New Hampshire, United States
• The Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• Hematology-Oncology Associates of Northern NJ — Morristown, New Jersey, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Weill Cornell Medical College — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Mitchell Cancer Center, University of South Alabama — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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