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Second STOP After Pioglitazone Priming in CML Patients (PIO2STOP)

Primary Purpose

Chronic Myeloid Leukemia (CML)

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Pioglitazone + TKI

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia (CML)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

CML in any phase. patient in MR4
Loss of MMR following a first or subsequent TKI discontinuation trial.
Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib
Age >18 years.
Serum bilirubin <1.5 x upper limit of normal values.
AST (SGOT)/ALT (SGPT) <2.5x upper limit of normal values.
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.
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.
Signed informed consent.
Be able and willing to comply with study visits and procedures

Exclusion Criteria:

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

Sites / Locations

Centre Hospitalier de VersaillesRecruiting
Hôpital Bicêtre
CHU de Nantes
CHU de Rennes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CML patients following molecular response loss

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.

Secondary Outcome Measures

Full Information

NCT ID

NCT02889003

First Posted

August 19, 2016

Last Updated

March 20, 2018

Sponsor

Versailles Hospital

Collaborators

Pr Philippe ROUSSELOT

1. Study Identification

Unique Protocol Identification Number

NCT02889003

Brief Title

Second STOP After Pioglitazone Priming in CML Patients

Acronym

PIO2STOP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Versailles Hospital

Collaborators

Pr Philippe ROUSSELOT

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Myeloid Leukemia (CML)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CML patients following molecular response loss

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Pioglitazone + TKI

Primary Outcome Measure Information:

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Time Frame

Up to 24 months after inclusion

Title

Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.

Time Frame

Up to 24 months after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: CML in any phase. patient in MR4 Loss of MMR following a first or subsequent TKI discontinuation trial. Patient prior treated with imatinib, dasatinib, nilotinib, or bosutinib Age >18 years. Serum bilirubin <1.5 x upper limit of normal values. AST (SGOT)/ALT (SGPT) <2.5x upper limit of normal values. 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. 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. Signed informed consent. Be able and willing to comply with study visits and procedures Exclusion Criteria: Known loss of CCyR by marrow cytogenetic or blood FISH for BCR-ABL1. Loss of CHR. Participation in another clinical trial with any investigative drug within 30 days prior to study enrolment. Prior allogeneic hematopoietic stem cell transplantation. Patient requiring anti-diabetic medications to manage hyperglycemia. Cardiovascular disease: history of congestive heart failure, myocardial infarction within the 6 months of study entry, symptomatic cardiac arrhythmia requiring treatment. Hepatic insufficiency History of bladder cancer. Diagnosed hematuria. Known osteoporosis with curative therapy (prophylactic therapy is not an exclusion criteria) Known history of macular edema. Known history of ABL1-domain mutation associated with resistance to the discontinued TKI. Known allergy to PIO. Pregnant or breastfeeding. Use of TZD within 28 days prior to enrollment. Significant gastrointestinal condition that could potentially impair the absorption or disposition of the drug. Uncontrolled peripheral edema (2+ or more) of any etiology

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Noémie DE GUNZBURG, Investigator coordinator

ndegunzburg@ch-versailles.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Amina CATTENOY, Project Manager

acattenoy@ch-versailles.fr

Facility Information:

Facility Name

Centre Hospitalier de Versailles

City

Le Chesnay

ZIP/Postal Code

78150

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Noémie DE GUNZBURG

ndegunzburg@ch-versailles.fr

First Name & Middle Initial & Last Name & Degree

Philippe ROUSSELOT

Facility Name

Hôpital Bicêtre

City

Le Kremlin-Bicêtre

ZIP/Postal Code

94275

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ali TURHAN

ali.turhan@aphp.fr

Facility Name

CHU de Nantes

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Viviane DUBRUILLE

viviane.dubruille@chu-nantes.fr

Facility Name

CHU de Rennes

City

Rennes

ZIP/Postal Code

35033

Country

France

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Martine ESCOFFRE-BARBE

Martine.escoffre-barbe@chu-rennes.fr

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Second STOP After Pioglitazone Priming in CML Patients

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