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Chronic Lymphocytic Leukemia (CLL)Phase 2NCT01419691

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

A Phase 2 study testing auranofin in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma, run by University of Kansas Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
auranofin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
Sep 2011to Sep 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

About this study

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)

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).

Being tested
auranofin
Keywords
auranofin, chronic lymphocytic leukemia, relapsed, refractory, CLL, SLL, PLL
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • auranofinDrug

    Also called Ridaura

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

Study groups in NCT01419691
Study groupRoleWhat they receive
Phase 2 DoseExperimentalAuranofin 6 mg orally in the morning / 6 mg orally in the evening
Receives: Drug: auranofin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate

    Measured: 24 months

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01419691
Sponsor's protocol ID
12838
Other IDs
Hem-2011-05-01
Status last verified
Jan 2016
First submitted
16 Aug 2011
Last updated
18 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35254001

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing auranofin in people with Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma, run by University of Kansas Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01419691, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.

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