Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma

Completed · Phase 3

Conditions studied: Follicular Lymphoma

In brief

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.

Key facts

Study ID

NCT01476787

Run by

Celgene

People needed

1030

Starts

2011-12-29

Expected to finish

2024-04-30

Last updated by the study team

2025-05-14

Who can join

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

You may qualify if…

• Histologically confirmed follicular lymphoma grade 1, 2 or 3a, Stage II-IV
• Have no prior systemic treatment for lymphoma
• Symptomatic follicular lymphoma requiring treatment.
• Age ≥18 years
• Eastern Cooperative oncology group performance status 0-2
• Willing to follow pregnancy precautions

You may not qualify if…

• Clinical evidence of transformed lymphoma or Grade 3b follicular lymphoma.
• Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
• 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
• At high risk for a venous thromboembolic event (VTE) and not willing to take VTE prophylaxis
• Any of the following laboratory abnormalities:
• serum aspartate transaminase or alanine transaminase > 3x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
• total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma
• creatinine clearance of < 30 mL/min

Where it is running

• Local Institution - 54103 — Chandler, Arizona, United States
• Local Institution - 51803 — Fullerton, California, United States
• Local Institution - 52003 — Los Angeles, California, United States
• Local Institution - 51603 — Colorado Springs, Colorado, United States
• Local Institution - 52503 — Englewood, Florida, United States
• Local Institution - 51703 — Orlando, Florida, United States
• Local Institution - 53803 — St. Petersburg, Florida, United States
• Local Institution - 50803 — Chicago, Illinois, United States
• Local Institution - 52203 — Lexington, Kentucky, United States
• Local Institution - 53603 — Westminster, Maryland, United States
• Local Institution - 50403 — Boston, Massachusetts, United States
• Local Institution - 50503 — Boston, Massachusetts, United States
• Local Institution - 53003 — Southfield, Michigan, United States
• Local Institution - 51003 — St Louis, Missouri, United States
• Local Institution - 54403 — Cherry Hill, New Jersey, United States
• Local Institution - 53703 — Hackensack, New Jersey, United States
• Local Institution - 50903 — Morristown, New Jersey, United States
• Local Institution - 54303 — Sparta, New Jersey, United States
• Local Institution - 52403 — New York, New York, United States
• Local Institution - 50203 — New York, New York, United States
• Local Institution - 51303 — Nashville, Tennessee, United States
• Local Institution - 51203 — Dallas, Texas, United States
• Local Institution - 51103 — Houston, Texas, United States
• Local Institution - 54003 — Lubbock, Texas, United States
• Local Institution - 53303 — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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