Second STOP After Pioglitazone Priming in CML Patients

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Pioglitazone + TKI

Первичные конечные точки

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Срок оценки: Up to 24 months after inclusion]
• Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation. [Срок оценки: Up to 24 months after inclusion]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 6 центров

• Centre Hospitalier de Versailles — Le Chesnay
• Hôpital Bicêtre — Le Kremlin-Bicêtre
• CHU Lyon — Lyon
• CHU de Nantes — Nantes
• CHU de Rennes — Rennes
• IUCT — Toulouse

Идентификаторы

NCT: NCT02889003 · P16/05_PIO2STOP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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