Study of Ibrutinib and Rituximab in Treatment Na ve Follicular Lymphoma

  • End date
    Jan 30, 2025
  • participants needed
  • sponsor
    Pharmacyclics LLC.
Updated on 16 June 2021
Divya Chari
Primary Contact
Uniklinikum Salzburg (0.0 mi away) Contact
+220 other location
measurable disease
follicular lymphoma


The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment nave subjects with follicular lymphoma.

Condition Follicular Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, Treatment Naive Follicular Lymphoma
Treatment Rituximab, Ibrutinib, placebo to match ibrutinib
Clinical Study IdentifierNCT02947347
SponsorPharmacyclics LLC.
Last Modified on16 June 2021


Yes No Not Sure

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
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