NCT01744691

A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion

An Open-label, Single Arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 (Ibrutinib) in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma With 17p Deletion (RESONATE™-17)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion

Detailed description

This is a multicenter, international, open-label, single arm, Phase 2 study designed to evaluate the efficacy and safety of ibrutinib in subjects with relapsed/refractory CLL or SLL with del 17p. All subjects will receive ibrutinib until disease progression or unacceptable toxicity occurs.

Conditions

• Chronic Lymphocytic Leukemia With 17p Deletion
• Small Lymphocytic Lymphoma With 17p Deletion

Interventions

Type	Name	Description
DRUG	Ibrutinib	All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2016-04-01
• First posted: 2012-12-07
• Last updated: 2017-02-27
• Results posted: 2015-06-09

Locations

55 sites across 9 countries: United States, Australia, Belgium, Canada, Germany, New Zealand, Sweden, Turkey (Türkiye), United Kingdom