NCT01980654

Study of Ibrutinib in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma

A Multicenter, Open-Label, Phase 2 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab in Previously Untreated Subjects With Follicular Lymphoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with Follicular Lymphoma (FL).

Detailed description

This is an open-label, Phase 2 study designed to assess the efficacy and safety of ibrutinib combined with rituximab in previously untreated subjects with FL. There are two study treatment arms. Subjects enrolled into main study treatment arm will receive ibrutinib continuously until disease progression or unacceptable toxicity. In addition, subjects will receive rituximab once weekly for four doses for the first four weeks of study treatment. Subjects enrolled into the exploratory study treatment arm will receive ibrutinib continuously as a single agent for the first eight weeks, then ibrutinib concurrently with rituximab once weekly for four doses. After the rituximab treatment, subjects will receive ibrutinib continuously until disease progression or unacceptable toxicity.

Conditions

• Follicular Lymphoma
• B-cell Lymphoma
• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	All subjects will receive 560 mg of Ibrutinib orally.
DRUG	rituximab	All subjects will receive rituximab 375 mg/m2 intravenously

Timeline

• Start date: 2013-12-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2013-11-11
• Last updated: 2019-04-16
• Results posted: 2019-04-16

Locations

12 sites across 1 country: United States