2024-518971-76-00招募中2 期
With Ponatinib on the track for treatment-free-remission in chronic myeloid leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- MR4 after 24 months of ponatinib treatment
研究概览
简要总结
Assessment of patients who achieved MR4 after 2 years of treatment with ponatinib.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Female or male ≥ 18 years of age
- •Patients with CML in chronic phase (CP)
- •BCR-ABL IS between 0,5-0,01 and demonstrated by the last PCR before inclusion
- •not achieving MR4 (defined as < 0,01% BCR-ABLIS) or not achieving a stable MR4 (defined as no continuous in MR4 during the last 12 months before inclusion) after ≥ 3 years of treatment with nilotinib, dasatinib and / or bosutinib in first or second line
- •Philadelphia -chromosome and/or BCR-ABL (either b3a2 and /or b2a2) fusion gene positive CML
- •Patients must have had an eye examination including fundoscopy by an ophthalmologist within 8 weeks prior to first treatment
排除标准
- •Failure of any TKI at any time during CML treatment according to current ELN criteria (including any detection of mutations or additional cytogenetic aberrations)
- •No adequate hepatic function (total serum bilirubin > 1.5 × ULN, unless due to Gilbert’s syndrome; Alanine aminotransferase (ALAT) > 2.5 × ULN, or > 5 × ULN if leukemic infiltration of the liver is present; aspartate aminotransferase (ASAT) > 2.5 × ULN, or > 5 × ULN if leukemic infiltration of the liver is present)
- •Positive hepatitis B virus serology test
- •No adequate pancreatic function (serum lipase and amylase >1.5 × ULN)
- •No adequate renal function [estimated creatinine clearance (eGFR) of < 90 ml/min
- •Other severe or uncontrolled medical conditions(e.g. Infection)
- •Women who are pregnant or breast feeding
- •positive serum pregnancy test (of woman with childbearing potential)
- •woman of childbearing potential not agreeing to use an higly-effective form of contraception or fertile male not agreeing to use an acceptable birth control method (for definition see appendix) with sexual partners throughout study participation until 90 days after EoT.
- •Legally incapacitated
- •No ability to comprehend and sign the informed consent.
- •Prior diagnosis of accelerated phase (AP) or blast phase (BP) at any time in the history of the disease
- •Held in an institution by legal or official order
- •Not able to take oral therapy
- •No willingness or ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- •Participation in other clinical trials
- •History of myocardial infarction
- •History of significant (as determined by the treating physician) atrial or ventricular arrhythmias
- •History of coronary heart disease
- •History of congenital long QT syndrome or family
- •Use of a ventricular paced pacemaker
- •History of other clinically significant heart disease (e.g. unstable angina, congestive heart failure) or impaired cardiac function
- •Previously planned or performed allogenic SCT
- •History of hyperlipidaemia
- •History of cerebrovascular accident (CVA, e.g. stroke) or transient ischemic attack (TIA)
- •History of peripheral vascular infarction, including visceral infarction or other vascular occlusive events
- •History of any revascularization procedure, (e.g. placement of stents, bypasses)
- •Venous thromboembolism, including deep venous thrombosis or pulmonary embolism, within 6 months prior to enrolment
- •Historiy of retinal venous occlusions
- •History of moderate or severe acute or chronic liver disease
- •History of alcohol abuse
- •History of severe hypertriglyceridemia
- •Either acute pancreatitis within 1 year before study entry or chronic pancreatitis
- •High cardiac risk according to ESC score (≥ 10%) (results of screening)
- •Renal artery stenosis
- •Moderate , severe or end-stage chronic renal disease unrelated to tumor
- •Severe diabetes with end organ damage (e.g. microalbuminuria) or poorly controlled diabetes, defined as HbA1c values over the previous year of > 7.5% (59 mmol/mol) on more than 3 occasions. Patients with pre-existing, well-controlled diabetes are not excluded.
- •Bleeding issues
- •Any other malignancy except if neither clinically significant nor requires active intervention.
- •Clinically significant resting bradycardia (<50 bpm) or tachycardia (>100 bpm) (results of screening)
- •QTcF interval on baseline electrocardiogram (ECG) evaluation, defined as QTcF of >450 ms in males or > 470 ms in females (results of screening)
- •Treatment with inhibitors of CYP3A4 or medications that have been well documented to prolong the QT interval
- •Uncontrolled hypertension (diastolic blood pressure ≥ 90 mm Hg; systolic ≥ 140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control
- •Ankle-brachial-index (ABI) < 0,9 or >1,4 or alternatively signs of arterial occlusion in duplex sonography
结局指标
主要结局
MR4 after 24 months of ponatinib treatment
MR4 after 24 months of ponatinib treatment
次要结局
- Molecular status (no MMR, MMR, MR4, and MR4.5) at the evaluation times defined in the visit schedule
- Time from inclusion to first MR4 and to first MR4.5
- Safety profile, tolerability and adverse events under ponatinib treatment
- Health-related quality of life (QoL) under ponatinib treatment
- Identification of clinical and biological factors associated with the achievement of MR4 or better under ponatinib (e.g. risk scores (Sokal/Euro/EUTOS/ ELTS), gender, duration of TKI treatment, molecular level at study entry
- Evaluation of medico-economic impact of ponatinib therapy with the possibility of a TFR approach
- Evaluation of overall survival and progression-free survival
研究者
Prof. Dr. med. Susanne Saußele
Scientific
Heidelberg University
研究点 (3)
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