Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Completed · Phase 3 · Has a placebo group

Conditions studied: Follicular Lymphoma

In brief

This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve participants with follicular lymphoma (FL).

Key facts

Study ID

NCT02947347

Run by

Pharmacyclics LLC.

People needed

445

Starts

2017-01-23

Expected to finish

2025-06-09

Last updated by the study team

2026-03-17

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of follicular lymphoma CD20+ (Grade 1, 2 or 3a) Ann Arbor Stage II, III or IV disease.
• Measurable disease
• Subjects 70 years of age or older; OR subjects 60-69 years of age who have one or more comorbidities.
• Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
• Adequate hematologic function within protocol-defined parameters.
• Adequate hepatic and renal function within protocol-defined parameters.
• ECOG performance status score of 0-2.

You may not qualify if…

• Transformed lymphoma
• Prior treatment for follicular lymphoma.
• Central nervous system lymphoma or leptomeningeal disease.
• Currently active, clinically significant cardiovascular disease.

Where it is running

• City of Hope — Duarte, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• UCLA Hematology/Oncology — Santa Monica, California, United States
• Helen F. Graham Cancer Center and Research Institute — Newark, Delaware, United States
• SCRI Florida Cancer Specialists South — Fort Myers, Florida, United States
• Florida Cancer Affiliates — Ocala, Florida, United States
• SCRI Florida Cancer Specialists North — St. Petersburg, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Goldschmidt Cancer Center — Jefferson City, Missouri, United States
• Southeast Nebraska Cancer Center — Lincoln, Nebraska, United States
• OHSU Knight Cancer Institute Beaverton Clinic — Beaverton, Oregon, United States
• Greenville Health System — Greenville, South Carolina, United States
• SCRI Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
• SCRI Tennessee Oncology Nashville — Nashville, Tennessee, United States
• Texas Oncology (Medical City) — Dallas, Texas, United States
• Texas Oncology-Dallas Presbyterian Hospital — Dallas, Texas, United States
• SCRI The Center For Cancer and Blood Disorders — Fort Worth, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Texas Oncology (Tyler) — Tyler, Texas, United States
• Oncology and Hematology Associates of Southwest Virginia (Blacksburg) — Blacksburg, Virginia, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Medical Oncology Associates — Spokane, Washington, United States
• W VA University Mary Babb Randolph Cancer Center — Morgantown, West Virginia, United States
• Southern Cancer Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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