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

Sponsor

University of Kansas Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01419691

Collaborator

The Leukemia and Lymphoma Society (Other), Kansas Bioscience Authority (Other), Therapeutics for Rare and Neglected Diseases (TRND) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Lymphocytic Leukemia (CLL) Small Lymphocytic Lymphoma Leukemia, Prolymphocytic	Drug: auranofin	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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)

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase 2 Dose Auranofin 6 mg orally in the morning / 6 mg orally in the evening	Drug: auranofin 6 mg twice a day for a total of 12 mg total daily dose Other Names: Ridaura

Arm

Intervention/Treatment

Experimental: Phase 2 Dose

Auranofin 6 mg orally in the morning / 6 mg orally in the evening

Drug: auranofin

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

Other Names:

Ridaura

Outcome Measures

Primary Outcome Measures

Response Rate [24 months]
type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities [24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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