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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
(Arm A) ibrutinib + rituximab 		Participants to receive 560mg of ibrutinib once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
  • Drug: Ibrutinib Oral Capsule
    Ibrutinib 560mg administered orally daily
    Other names:
    • Imbruvica
  • Drug: Rituximab
    Rituximab 375mg/m^2 intravenously (IV) weekly
Placebo Comparator
(Arm B) placebo + rituximab 		Participants to receive placebo once daily and rituximab 375mg/m^2 weekly x4 with maintenance.
  • Drug: Placebo
    Placebo capsules to match ibrutinib administered orally daily
  • Drug: Rituximab
    Rituximab 375mg/m^2 intravenously (IV) weekly

More Details

Status
Completed
Sponsor
Pharmacyclics LLC.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.