NCT01724346

Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

An Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib Versus Chlorambucil)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

An Open-label Extension Study in Patients 65 Years or Older with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Who Participated in Study PCYC-1115-CA (Ibrutinib versus Chlorambucil)

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily
DRUG	Next-line ibrutinib	Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily

Timeline

• Start date: 2013-12-03
• Primary completion: 2023-08-18
• Completion: 2023-08-18
• First posted: 2012-11-09
• Last updated: 2024-09-19
• Results posted: 2024-09-19

Locations

88 sites across 16 countries: United States, Australia, Belgium, Canada, China, Czechia, Ireland, Israel, Italy, New Zealand, Poland, Russia, Spain, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study