Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of auranofin to treat patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or prolymphocytic lymphoma (PLL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center
• Collaborators: Kansas Bioscience Authority; The Leukemia and Lymphoma Society; Therapeutics for Rare and Neglected Diseases (TRND)
• Treatments: Auranofin

Criteria

Inclusion Criteria:

• histologically confirmed B-cell chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), prolymphocytic leukemia arising from CLL/SLL or Richter's transformation according to WHO criteria who require therapy based on the 2008 revised IWCLL criteria.

• Relapsed or refractory disease after receiving at least 1 prior therapy for CLL

• At least 18 years old; ECOG status of 1 or less; life expectancy 2 months or greater

• Adequate organ and marrow function (total bilirubin less than 1.5x IULN; ALT less than 2x IULN; serum creatinine less than 1.5x ULN)

Exclusion Criteria:

• have had chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to entering study

• have not recovered from AEs due to agents administered more than 4 weeks prior

• receiving any other investigational agent

• known second malignancy that limits survival to less than 2 years

• known HIV positive

• uncontrolled intercurrent illness

• pregnant or breastfeeding