Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Pharmacyclics

Status and phase: Completed; Phase 3

Conditions: Follicular Lymphoma

Treatments: Drug: ibrutinib; Drug: placebo to match ibrutinib; Drug: rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02947347

2016-003202-14 (EudraCT Number)

PCYC-1141-CA

Details and patient eligibility

About

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.

Enrollment: 445 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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445 participants in 2 patient groups, including a placebo group

(Arm A) ibrutinib + rituximab

Experimental group

Description:

Participants will receive 560mg of ibrutinib and rituximab 375mg/m\^2 weekly x4 with maintenance.

Treatment:

Drug: rituximab

Drug: ibrutinib

(Arm B) placebo + rituximab

Placebo Comparator group

Description:

Participants will receive placebo and rituximab 375mg/m\^2 weekly x4 with maintenance.

Treatment:

Drug: rituximab

Drug: placebo to match ibrutinib