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

This study has been completed.
Sponsor:
Collaborators:
The Leukemia and Lymphoma Society
Kansas Bioscience Authority
Therapeutics for Rare and Neglected Diseases (TRND)
Information provided by (Responsible Party):
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT01419691
First received: August 16, 2011
Last updated: January 15, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma
Leukemia, Prolymphocytic
Drug: auranofin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by University of Kansas Medical Center:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: September 2011
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419691

Locations
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)
Investigators
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 
Study First Received: August 16, 2011
Last Updated: January 15, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Kansas Medical Center:
auranofin
chronic lymphocytic leukemia
relapsed
refractory
CLL
SLL
PLL

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

ClinicalTrials.gov processed this record on July 26, 2016