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

Recurrent Small Lymphocytic Lymphoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Recurrence
  • Recurrent Chronic Lymphocytic Leukemia
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Refractory Small Lymphocytic Lymphoma
Clinical Trial Details
NCT number NCT03961672
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 13, 2020
Completion date June 27, 2024
View Details
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