PERSPECTIVE Study

Disease: Treatment Naïve Follicular Lymphoma  (FL)
Protocol: PCYC-1141-CA

Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma 

Study Schema N=440

Two part study:
  • Part 1: ibrutinib or placebo in combination with rituximab

  • Part 2: ibrutinib or placebo

Perspective Study

Primary Objective

  • To evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma

Key Eligibility Criteria

Key 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 lepto meningeal disease
  • Currently active, clinically significant cardiovascular disease

 

For more information on this trial, click below

The information provided herein may contain references to ibrutinib or a use of ibrutinib which has not been approved by any regulatory agency. Providing this information should not be construed as recommending the use of ibrutinib for uses which may not have been approved by any regulatory agency. The safety and efficacy of the investigational use of ibrutinib has not been determined. There is no guarantee that the investigational uses listed will be filed with and/or approved for marketing by any regulatory agency. For additional information, you may visit www.clinicaltrials.gov. For products approved by any regulatory agency please consult the product’s full prescribing information for a complete discussion of risks and benefits of the product for its approved indications.