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

Phase 2

Completed

• Conditions: Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma; Leukemia, Prolymphocytic
• Interventions: Drug: auranofin

• Registration Number: NCT01419691
• Lead Sponsor: University of Kansas Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Study Start: 2011-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-15
• Last Update Posted: 2016-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 2 Dose	auranofin	Auranofin 6 mg orally in the morning / 6 mg orally in the evening

Primary Outcome Measures

Name	Time	Method
Response Rate	24 months
type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities	24 months

Trial Locations

Locations (1)

University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States