Second STOP After Pioglitazone Priming in CML Patients

NCT02889003 | Unknown Phase 2 DMC

• 1 other identifier: P16/05_PIO2STOP
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Myeloid Leukemia (CML)

Outcome Measures

Primary Outcomes (2)

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

  Up to 24 months after inclusion

• Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.

  Up to 24 months after inclusion

Study Arms (1)

CML patients following molecular response loss

EXPERIMENTAL

Drug: Pioglitazone + TKI

Interventions

Pioglitazone + TKI DRUG

CML patients following molecular response loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Versailles Hospital: lead
• Pr Philippe ROUSSELOT: collaborator

Study Sites (4)

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

RECRUITING

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

NOT YET RECRUITING

CHU de Nantes

Nantes, 44093, France

NOT YET RECRUITING

CHU de Rennes

Rennes, 35033, France

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Noémie DE GUNZBURG, Investigator coordinator

CONTACT

ndegunzburg@ch-versailles.fr

Amina CATTENOY, Project Manager

CONTACT

acattenoy@ch-versailles.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator coordinator

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 5, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 22, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will share

Locations

FR (4)