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

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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01419691

Enrollment

Registered

2011-08-18

Start date

2011-09-30

Completion date

2015-09-30

Last updated

2016-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma, Leukemia, Prolymphocytic

Keywords

auranofin, chronic lymphocytic leukemia, relapsed, refractory, CLL, SLL, PLL

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).

Interventions

DRUGauranofin

6 mg twice a day for a total of 12 mg total daily dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026