NCT02889003招募中2 期
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
Versailles Hospital8 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2016年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 8
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Known loss of CCyR by marrow cytogenetic or blood FISH for BCR-ABL
- •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
研究组 & 干预措施
CML patients following molecular response loss
Experimental
干预措施: Pioglitazone + TKI (Drug)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Up to 24 months after inclusion
Treatment free survival after pioglitazone and tyrosine kinase inhibitor discontinuation.
时间窗: Up to 24 months after inclusion
次要结局
未报告次要终点
研究者
Philippe ROUSSELOT
Investigator coordinator
Versailles Hospital
研究点 (8)
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