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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Kansas
Sponsor:
Collaborators:
The Leukemia and Lymphoma Society
Kansas Bioscience Authority
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01419691
First received: August 16, 2011
Last updated: January 17, 2014
Last verified: January 2014
  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 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:

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 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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

Contacts
Contact: Jodi Carlson 913-945-7552 jcarlson@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
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: January 17, 2014
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 August 21, 2014