EUCTR2017-000899-28-NL进行中（未招募）1 期
Dipeptidylpeptidase IV (CD26) on Philadelphia-positive leukemic stem cells (LSC) as marker and novel therapeutic target in chronic myeloid leukemia (CML). - Dolphin-STAR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients =18 years of age.
- •2. At diagnosis chronic myeloid leukemia in chronic phase.
- •3. Previous relapse during attempt at TFR (Treatment Free Remission)
- •4. Documented regain of deep molecular remission at the level of at least MR4.0, defined as a measurable BCR-ABL level =0.01% IS or an undetectable BCR-ABL with a minimal total control gene copy number of ABL1 ?10?000 or GUSB ?24?000 in two replicates. A sample showing MR4.0 or better needs to have been taken within 31 days of study inclusion.
- •5. Continuous treatment with any TKI for a minimum of 12 months prior to entering the study
- •6. No other current or planned anti-leukemia therapy.
- •7. ECOG Performance status 0,1, or 2.
- •8. Adequate organ function as defined by:
- •a) Total bilirubin <1.5 x ULN (ULN = local lab upper limit of normal). Does not apply to patients with isolated hyperbilirubinemia (e.g. Gilbert’s disease) grade <3.
- •b) ASAT and ALAT <2.5 x ULN.
- •c) Serum amylase and lipase =1.5 x ULN.
- •d) Alkaline phosphatase =2.5 x ULN.
- •e) Creatinine clearance >30 ml/min.
- •f) Mg++, K+ =LLN.
- •9. Life expectancy of more than 12 months in the absence of any intervention
- •10. Written informed consent to participate in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Prior accelerated phase or blast crisis.
- •2. Patient has received another investigational agent within last 6 months.
- •3. Prior stem cell transplantation.
- •4. History of occlusive cardiovascular disease, including peripheral occlusive arterial disease, cerebrovascular disease and coronary artery disease.
- •5. Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension)
- •6. Increased risk of cardiac arrhythmia, defined as:
- •a) Inability to monitor the QT/QTc interval on ECG.
- •b) Long QT syndrome or a known family history of long QT syndrome.
- •c) Clinically significant resting brachycardia (<50 beats per minute).
- •d) QTc >450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
- •e) History of or presence of clinically significant ventricular or atrial tachyarrhythmias
- •6. Known atypical BCR-ABL transcript not quantifiable by standard RQ-PCR
- •7. History of active malignancy during the past 2 years with the exception of basal carcinoma of the skin or carcinoma in situ of cervix uteri or breast.
- •8. Acute liver disease or cirrhosis.
- •9. Previous or active acute or chronic pancreatic disease.
- •10. Another severe and/or life-threatening medical disease.
- •11. History of significant congenital or acquired bleeding disorder unrelated to cancer.
- •12. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
- •13. Patients actively receiving therapy with strong CYP3A4 inhibitors where the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
- •14. Patients who are currently receiving treatment with any medication that has the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
- •15. Patients who are:
- •a) pregnant.
- •b) breast feeding.
- •c) of childbearing potential without a negative pregnancy test prior to baseline.
- •d) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
- •16. Interruption of TKI therapy for a cumulative period in excess of 21 days in the preceding 3 months.
- •17. Known intolerance to nilotinib
- •18. Known intolerance to vildagliptin
- •19. History of non-compliance, or other inability to grant informed consent.
- •20. Past or present history of alcohol abuse, use of illicit drugs, or severe psychiatric disorders, including depression.
- •21. Autoimmune hepatitis or a history of autoimmune disease.
- •22. Pre-existing thyroid disease unless it can be controlled with conventional treatment.
- •23. Epilepsy and/or compromised central nervous system (CNS) function.
- •24. HCV/HIV patients.
- •25. Poorly controlled diabetes mellitus(i.e. HbA1c >9.0) or
- •clinically relevant diabetic complications such as neuropathy, retinopathy, nephropathy, coronary or peripheral vascular disease.
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