Phase I and II Study of Auranofin in Chronic Lymphocytic... | NCT01419691

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

NCT01419691

Sponsor

University of Kansas Medical Center

Status

Completed

Last Update Posted

Jan 18, 2016Estimated

Enrollment

15Actual

Phase

Phase 2

Conditions

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

Interventions

auranofin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Hem-2011-05-01	Other Grant/Funding Number	TRND/NIH and Leukemia Lymphoma Society

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Aug 16, 2011

First Submission Date that Met QC Criteria

Aug 17, 2011

First Posted Date

Aug 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2016

Last Update Posted Date

Jan 18, 2016Estimated

Name	Class
The Leukemia and Lymphoma Society	OTHER
Kansas Bioscience Authority	UNKNOWN
Therapeutics for Rare and Neglected Diseases (TRND)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 2 Dose	Experimental	Auranofin 6 mg orally in the morning / 6 mg orally in the evening	Drug: auranofin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
auranofin	Drug	6 mg twice a day for a total of 12 mg total daily dose	Phase 2 Dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response Rate		24 months
type, incidence, severity, seriousness and relationship to auranofin of adverse events and any laboratory abnormalities		24 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Suman Kambhampati, MD	University of Kansas Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Kansas Cancer Center		Westwood	Kansas	66205	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35254001	Derived	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.

ID	Term
D015451	Leukemia, Lymphocytic, Chronic, B-Cell
D015463	Leukemia, Prolymphocytic
D012008	Recurrence

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

ID	Term
D006051	Aurothioglucose
D050607	Organogold Compounds
D009942	Organometallic Compounds
D009930	Organic Chemicals