- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01419691
Phase I and II Study of Auranofin in Chronic Lymphocytic Leukemia (CLL)
January 15, 2016 updated by: University of Kansas Medical Center
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)
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kansas
-
Westwood, Kansas, United States, 66205
- University of Kansas Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 2 Dose
Auranofin 6 mg orally in the morning / 6 mg orally in the evening
|
6 mg twice a day for a total of 12 mg total daily dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response Rate
Time Frame: 24 months
|
24 months
|
type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Suman Kambhampati, MD, University of Kansas Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
August 16, 2011
First Submitted That Met QC Criteria
August 17, 2011
First Posted (Estimate)
August 18, 2011
Study Record Updates
Last Update Posted (Estimate)
January 18, 2016
Last Update Submitted That Met QC Criteria
January 15, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12838
- Hem-2011-05-01 (Other Grant/Funding Number: TRND/NIH and Leukemia Lymphoma Society)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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