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Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Trial Status: Active

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 subjects with follicular lymphoma.

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: ACTIVE
Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Rajneesh Reghunathan
Phone: 310-825-6969
South Pasadena
City of Hope South Pasadena
Status: ACTIVE
Upland
City of Hope Upland
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Oregon

Portland
OHSU Knight Cancer Institute
Status: ACTIVE

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479
Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Pharmacyclics LLC.

  • Primary ID PCYC-1141-CA
  • Secondary IDs NCI-2017-00193
  • Clinicaltrials.gov ID NCT02947347