Second STOP After Pioglitazone Priming in CML Patients (PIO2STOP)

March 20, 2018 updated by: Dr Noémie DE GUNZBURG, Versailles Hospital

Combination Study of Pioglitazone and Tyrosine Kinase Inhibitors (TKIs) in Chronic Myeloid Leukemia Patients After Failure of a First TKIs Discontinuation Attempt in Order to Prepare a New Stop

Single-center study, prospective, phase II trial.

The study objectives are :

  • To assess safety and pharmacokinetics of the combination of PIO and TKI in CML subjects who experience a loss of MMR following a first TKI discontinuation.
  • To assess survival without loss of MMR over a 12 months period following a second TKI discontinuation in subjects who achieve or maintain < MR4.5 with the combination PIO and TKI administered for at least 6 months.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

26

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 Contact

Study Contact Backup

Study Locations

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:

  1. CML in any phase. patient in MR4
  2. Loss of MMR following a first or subsequent TKI discontinuation trial.
  3. Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib
  4. Age >18 years.
  5. Serum bilirubin <1.5 x upper limit of normal values.
  6. AST (SGOT)/ALT (SGPT) <2.5x upper limit of normal values.
  7. Females of child bearing potential must agree to abstain from sexual activity or to use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. Women of child bearing potential must have a negative urine pregnancy test at the time of enrollment. Acceptable methods of birth control include oral contraceptive, intrauterine device, transdermal/implanted or injected contraceptives and abstinence.
  8. Males must agree to abstain from sexual activity or agree to utilize a medically-approved contraception method during and for 3 months after the treatment period.
  9. Signed informed consent.
  10. Be able and willing to comply with study visits and procedures

Exclusion Criteria:

  1. Known loss of CCyR by marrow cytogenetic or blood FISH for BCR-ABL1.
  2. Loss of CHR.
  3. Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment.
  4. Prior allogeneic hematopoietic stem cell transplantation.
  5. Patient requiring anti-diabetic medications to manage hyperglycemia.
  6. Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment.
  7. Hepatic insufficiency
  8. History of bladder cancer.
  9. Diagnosed hematuria.
  10. Known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria)
  11. Known history of macular edema.
  12. Known history of ABL1-domain mutation associated with resistance to the discontinued TKI.
  13. Known allergy to PIO.
  14. Pregnant or breastfeeding.
  15. Use of TZD within 28 days prior to enrollment.
  16. Significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug.
  17. Uncontrolled peripheral edema (2+ or more) of any etiology

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CML patients following molecular response loss
Drug: Pioglitazone + TKI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Up to 24 months after inclusion
Up to 24 months after inclusion
Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.
Time Frame: Up to 24 months after inclusion
Up to 24 months after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Versailles Hospital

Collaborators

Pr Philippe ROUSSELOT

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 (ACTUAL)

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

December 1, 2021

Study Registration Dates

First Submitted

August 19, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (ESTIMATE)

September 5, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P16/05_PIO2STOP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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Locations

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