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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507271-21-00

Acronym

PCYC-1141-CA

Enrollment

231

Registered

2024-02-19

Start date

2017-04-11

Completion date

2025-06-09

Last updated

2025-04-29

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

Conditions

Follicular Lymphoma

Brief summary

Progression-free survival (PFS)

Detailed description

• Overall response rate (ORR) (Cheson 2014), • Overall Survival (OS), • Infusion-related reaction rate (Arm A vs. Arm B), • Duration of response (DOR) as assessed by investigator, • Frequency, severity, seriousness, and relatedness of adverse events (AEs)

Interventions

DRUGIbrutinib hard capsule for oral use

DRUGIbrutinib

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	—

Secondary

Measure	Time frame
• Overall response rate (ORR) (Cheson 2014), • Overall Survival (OS), • Infusion-related reaction rate (Arm A vs. Arm B), • Duration of response (DOR) as assessed by investigator, • Frequency, severity, seriousness, and relatedness of adverse events (AEs)	—

Countries

Austria, Belgium, Czechia, France, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026