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

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 - PCYC-1141-CA PERSPECTIVE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54492

Enrollment

Registered

2017-06-07

Start date

2018-08-07

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follicular lymphoma lymphoma

Interventions

Subjects randomized to the investigational arm (Arm A) will receive ibrutinib 560 mg PO daily continuously in combination with rituximab 375 mg/m2 IV once weekly for the first 4 weeks of study treat

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: * Transformed lymphoma * Prior treatment for follicular lymphoma * Central nervous system lymphoma or leptomeningeal disease * Currently active, clinically significant cardiovascular disease

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
• Overall response rate (ORR) • Overall Survival (OS) • Infusion-related reaction rate (Arm A vs. Arm B) • Frequency, severity, seriousness, and relatedness of adverse events (AEs) • Duration of response (DOR) as assessed by investigator	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)