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

NCT ID: NCT01419691

Last Updated: 2016-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-09-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 2 Dose

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

Group Type EXPERIMENTAL

auranofin

Intervention Type DRUG

6 mg twice a day for a total of 12 mg total daily dose

Interventions

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auranofin

6 mg twice a day for a total of 12 mg total daily dose

Intervention Type DRUG

Other Intervention Names

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Ridaura

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Leukemia and Lymphoma Society

OTHER

Sponsor Role collaborator

Kansas Bioscience Authority

UNKNOWN

Sponsor Role collaborator

Therapeutics for Rare and Neglected Diseases (TRND)

NIH

Sponsor Role collaborator

University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suman Kambhampati, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

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University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35254001 (View on PubMed)

Other Identifiers

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Hem-2011-05-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

12838

Identifier Type: -

Identifier Source: org_study_id

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