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

Primary Purpose

Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma, Leukemia, Prolymphocytic

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
auranofin
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia (CLL) focused on measuring auranofin, chronic lymphocytic leukemia, relapsed, refractory, CLL, SLL, PLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Phase 2 Dose

Arm Description

Auranofin 6 mg orally in the morning / 6 mg orally in the evening

Outcomes

Primary Outcome Measures

Response Rate
type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities

Secondary Outcome Measures

Full Information

First Posted
August 16, 2011
Last Updated
January 15, 2016
Sponsor
University of Kansas Medical Center
Collaborators
The Leukemia and Lymphoma Society, Kansas Bioscience Authority, Therapeutics for Rare and Neglected Diseases (TRND)
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1. Study Identification

Unique Protocol Identification Number
NCT01419691
Brief Title
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
The Leukemia and Lymphoma Society, Kansas Bioscience Authority, Therapeutics for Rare and Neglected Diseases (TRND)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma, Leukemia, Prolymphocytic
Keywords
auranofin, chronic lymphocytic leukemia, relapsed, refractory, CLL, SLL, PLL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2 Dose
Arm Type
Experimental
Arm Description
Auranofin 6 mg orally in the morning / 6 mg orally in the evening
Intervention Type
Drug
Intervention Name(s)
auranofin
Other Intervention Name(s)
Ridaura
Intervention Description
6 mg twice a day for a total of 12 mg total daily dose
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
24 months
Title
type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suman Kambhampati, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35254001
Citation
Rousselle B, Massot A, Privat M, Dondaine L, Trommenschlager A, Bouyer F, Bayardon J, Ghiringhelli F, Bettaieb A, Goze C, Paul C, Malacea-Kabbara R, Bodio E. Conception and Evaluation of Fluorescent Phosphine-Gold Complexes: From Synthesis to in vivo Investigations. ChemMedChem. 2022 Jun 3;17(11):e202100773. doi: 10.1002/cmdc.202100773. Epub 2022 Mar 29.
Results Reference
derived

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

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