This study is in progress, not accepting new patients

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

a study on Lymphoma

Summary

Eligibility
for people ages 60 years and up (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around

Description

Summary

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 naïve participants with follicular lymphoma.

Official Title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)

Keywords

Follicular Lymphoma, Lymphoma, Rituximab, Ibrutinib

Eligibility

You can join if…

Open to people ages 60 years and up

  • 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 CAN'T join if...

Locations

  • UCLA Hematology/Oncology
    Santa Monica California United States
  • City of Hope
    Duarte California United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pharmacyclics LLC.
ID
NCT02947347
Phase
Phase 3 Lymphoma Research Study
Study Type
Interventional
Participants
About 445 people participating
Last Updated