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

Small Lymphocytic Lymphoma Clinical Trial

Official title:

A Phase I Phase II Two-Step Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL)/ Prolymphocytic Lymphoma (PLL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419691
• Other study ID #: 12838
• Secondary ID: Hem-2011-05-01
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2011
• Last updated: January 15, 2016
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia (CLL)
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Leukemia, Prolymphocytic
• Small Lymphocytic Lymphoma

Intervention

Drug:
• auranofin
6 mg twice a day for a total of 12 mg total daily dose

Locations

Country	Name	City	State
United States	University of Kansas Cancer Center	Westwood	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Kansas Bioscience Authority, The Leukemia and Lymphoma Society, Therapeutics for Rare and Neglected Diseases (TRND)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		24 months	Yes
Primary	type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities		24 months	Yes