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

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ClinicalTrials.gov Identifier: NCT01419691
Recruitment Status : Completed
First Posted : August 18, 2011
Last Update Posted : January 18, 2016
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

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

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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
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


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




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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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


Locations
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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
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Principal Investigator: Suman Kambhampati, MD University of Kansas Medical Center

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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:
auranofin
chronic lymphocytic leukemia
relapsed
refractory
CLL
SLL
PLL

Additional relevant MeSH terms:
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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