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Completed

NCT Number: NCT01419691

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

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).

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Key information

Conditions

Chronic Lymphocytic Leukemia (CLL) Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Prolymphocytic Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Small Lymphocytic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auranofin

Drug

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

Other names: Ridaura

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

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

Registry information

Official study 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)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2011
Registry last updated
Jan 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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