NCT02049515

A Phase 3 Extension Study of Duvelisib and Ofatumumab in Participants With CLL/SLL Previously Enrolled in Study IPI-145-07

A Study of IPI-145 and Ofatumumab in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Previously Enrolled in Study IPI-145-07 Duvelisib (IPI-145)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3 (extension) clinical trial to examine the efficacy of IPI-145 (duvelisib) monotherapy or ofatumumab monotherapy in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who experienced disease progression after treatment with IPI-145 or ofatumumab in study IPI-145-07 (NCT02004522).

Detailed description

The study was designed as an open-label, two-arm extension evaluation to enable participants who experienced radiologically confirmed disease progression in study IPI-145-07 to receive the alternative treatment (either IPI-145 or ofatumumab) other than what was received during study IPI-145-07. Participants who previously had received ofatumumab in study IPI-145-07 received a starting dose of 25 milligrams (mg) IPI-145 twice daily continuously in a 21-day cycle for Cycle 1, followed by 28-day treatment cycles thereafter for up to 11 cycles or until disease progression, discontinuation from study participation, or start of subsequent therapy, whichever occurred first. After completing approximately 11 cycles of treatment with duvelisib, participants who, in the judgment of the investigator, may have derived benefit from continued treatment may have continued to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 11 cycles, participants must have had evidence of response and CLL/SLL requiring treatment according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL)/International Working Group by Cycle 12 Day 1. Participants who previously received IPI-145 in study IPI-145-07 received treatment consistent approved product labeling which consisted of a starting dose of 300 mg ofatumumab on Day 1, followed by seven weekly doses of 2000 mg. Thereafter, participants received 2000 mg ofatumumab once every month for four months unless disease progression or unacceptable toxicity occurred. Administration of ofatumumab was not to exceed the 12 doses (within 7 cycles).

Conditions

• Chronic Lymphocytic Leukemia
• Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	IPI-145	PI3K Inhibitor
DRUG	Ofatumumab	Monoclonal antibody

Timeline

• Start date: 2013-12-01
• Primary completion: 2020-06-12
• Completion: 2020-06-12
• First posted: 2014-01-30
• Last updated: 2023-09-21
• Results posted: 2023-02-21

Locations

69 sites across 11 countries: United States, Australia, Austria, Belgium, France, Germany, Hungary, Italy, New Zealand, Spain, United Kingdom