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

This study is currently recruiting participants.
Verified May 2013 by University of Kansas
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
ClinicalTrials.gov Identifier:
NCT01419691
First received: August 16, 2011
Last updated: May 13, 2013
Last verified: May 2013
History of Changes
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Two-Step Phase II Study of the Oral Gold Compound Auranofin in Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)/Prolymphocytic Lymphoma (PLL)

Resource links provided by NLM:

Drug Information available for: Auranofin
U.S. FDA Resources

Further study details as provided by University of Kansas:

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 ]

Estimated Enrollment: 27
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: auranofin
    6 mg once a day
    Other Name: Ridaura
  Eligibility

Ages Eligible for Study:   18 Years and older
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 2 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419691

Contacts
Contact: Cassandra Pitts 913-588-4769 cpitts@kumc.edu
Contact: Suman Kambhampati, MD 913-588-6029 skambhampati@kumc.edu

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

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01419691     History of Changes
Other Study ID Numbers: 12838, Hem-2011-05-01
Study First Received: August 16, 2011
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 22, 2013