We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01419691
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : January 18, 2016
Information provided by (Responsible Party):

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  (Clinical Trial)
Actual Enrollment : 15 participants
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 : September 2011
Primary Completion Date : September 2015
Study Completion Date : September 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 Name: Ridaura

Outcome Measures

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 24 months ]
  2. type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419691

United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Sponsors and Collaborators
University of Kansas Medical Center
The Leukemia and Lymphoma Society
Kansas Bioscience Authority
Therapeutics for Rare and Neglected Diseases (TRND)
Principal Investigator: Suman Kambhampati, MD University of Kansas Medical Center
More Information

Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01419691     History of Changes
Other Study ID Numbers: 12838
Hem-2011-05-01 ( Other Grant/Funding Number: TRND/NIH and Leukemia Lymphoma Society )
First Posted: August 18, 2011    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Keywords provided by University of Kansas Medical Center:
chronic lymphocytic leukemia

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Prolymphocytic
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antirheumatic Agents