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

University of Kansas

Status and phase

Completed

Phase 2

Conditions

Small Lymphocytic Lymphoma

Leukemia, Prolymphocytic

Chronic Lymphocytic Leukemia (CLL)

Treatments

Drug: auranofin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01419691

12838

Hem-2011-05-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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