NCT03961672

Intermittent Duvelisib Dosing in Treating Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

A Phase II Study of Intermittent Duvelisib Dosing in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well duvelisib on an intermittent (irregular) dosing schedule works in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving duvelisib on an intermittent schedule may result in similar effectiveness with less amount of severe side effects.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of duvelisib (induction followed by maintenance \[intermittent dosing\]) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), as measured by the progression free survival (PFS). SECONDARY OBJECTIVES: I. To evaluate safety of duvelisib induction and maintenance (by intermittent dosing) in relapsed/refractory CLL. II. To evaluate clinical benefits to duvelisib treatment. EXPLORATORY OBJECTIVE: I. To evaluate T-cell populations in patients with CLL treated with duvelisib. OUTLINE: INDUCTION: Patients receive duvelisib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days for 12 weeks in the absence of disease progression or unacceptable toxicity. MAINTENANCE: Patients receive duvelisib PO BID on days 1-2, 8-9, 15-16, and 22-23. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for up to 12 months.

Conditions

• Recurrent Chronic Lymphocytic Leukemia
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Small Lymphocytic Lymphoma

Interventions

Type	Name	Description
DRUG	Duvelisib	Given PO

Timeline

• Start date: 2020-05-13
• Primary completion: 2023-07-31
• Completion: 2026-10-26
• First posted: 2019-05-23
• Last updated: 2026-01-05
• Results posted: 2024-08-07

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study