Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
Versailles Hospital (Voir sur ClinicalTrials)
décembre 2016
décembre 2021
06 juillet 2026
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | Noémie DE GUNZBURG | Contact (sur clinicalTrials) | |||
| IFSI DE L'HÔPITAL BICÊTRE | Ali TURHAN | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Rennes - 35033 - Rennes - France | Martine ESCOFFRE-BARBE | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Nantes - 44093 - Nantes - France | Viviane DUBRUILLE | Contact (sur clinicalTrials) | |||
Critères
Tous
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
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
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