drugset / Trial / NCT04691765

Anakinra in Previously Untreated Chronic Lymphocytic Leukemia Patients

NCT04691765

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a phase I trial of the IL-1 receptor antagonist anakinra in chronic lymphocytic leukemia patients who are predicted to eventually require first-line therapy based on conventional clinical criteria. Three groups of 4 patients will be injected subcutaneously with either 100 mg daily or 100 mg twice daily or 200 mg twice daily for 7 cycles of 4 weeks each to determine the dose-limiting toxicity of anakinra in this population. Clinical responses will be determined by conventional IWCLL criteria. It is hoped anakinra will prevent disease progression with little toxicity. The study is anticipated to be completed within a year.

Timeline

Start
2021-05-01
Primary completion
2021-12
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic 100 mg Subcutaneous
Subject Anakinra Protein / enzyme biologic 200 mg Subcutaneous