Status:
COMPLETED
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
The Leukemia and Lymphoma Society
Kansas Bioscience Authority
Conditions:
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 lympho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01419691
Start Date
September 1 2011
End Date
September 1 2015
Last Update
January 18 2016
Active Locations (1)
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1
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205