NCT01419691

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2011

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 18, 2016

Status Verified

January 1, 2016

Enrollment Period

4 years

First QC Date

August 16, 2011

Last Update Submit

January 15, 2016

Conditions

Chronic Lymphocytic Leukemia (CLL)Small Lymphocytic LymphomaLeukemia, Prolymphocytic

Keywords

auranofinchronic lymphocytic leukemiarelapsedrefractoryCLLSLLPLL

Outcome Measures

Primary Outcomes (2)

  • Response Rate

    24 months

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

    24 months

Study Arms (1)

Phase 2 Dose

EXPERIMENTAL

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

Drug: auranofin

Interventions

auranofinDRUG

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

Also known as: Ridaura
Phase 2 Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Related Publications (1)

  • 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.

    PMID: 35254001DERIVED

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-CellLeukemia, ProlymphocyticRecurrence

Interventions

Auranofin

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AurothioglucoseOrganogold CompoundsOrganometallic CompoundsOrganic Chemicals

Study Officials

  • Suman Kambhampati, MD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2011

First Posted

August 18, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 18, 2016

Record last verified: 2016-01

Locations

US(1)