EUCTR2009-012616-40-GB进行中（未招募）不适用
An Open Label, Randomized Study of Nilotinib vs. Standard Imatinib (400/600 mg QD) Comparing the Kinetics of Complete Molecular Response for CML-CP Patients with Evidence of Persistent Leukemia by RQ-PCR
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 192
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 old
- •2. Diagnosis of chronic myeloid leukemia in chronic phase (CML-CP) associated with BCR-ABL quantifiable by RQ-PCR (IS)
- •3. Documented CCyR* by bone marrow (standard cytogenetic test) or peripheral blood BCR-ABL<1% IS as defined in Appendix 1 of protocol
- •4. Persistent disease demonstrated by two PCR positive tests (ie., BCR-ABL level <1% IS) which have been performed during the past nine months and are at least 10 weeks apart. One of these should be performed within 3 months of randomization (see definition of persistent disease in Appendix 1).
- •5. Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose (the dose has not changed in the previous 6 months.) Patients who received imatinib 800 mg/day in the past, but the dose was subsequently reduced to 600 mg or 400 mg/day more than 6 months before the randomization are also eligible for this study.
- •6. Must have been treated with Glivec®/Gleevec®
- •7. No other current or planned anti-leukemia therapies
- •8. ECOG Performance status 0,1, or 2
- •9. Adequate end-organ function as defined by:
- •a. Total bilirubin < 1.5 x ULN (ULN = upper limit of normal in a local institution lab). Does not apply to patients with isolated hyperbilirubinemia (e.g., Gilbert’s disease) grade <3.
- •b. AST (SGOT) and ALT (SGPT) < 2.5 x ULN
- •c. Serum amylase and lipase = 1.5 x ULN
- •d. Alkaline phosphatase = 2.5 x ULN
- •10. Patients must have the following laboratory values (WNL = within normal limits at the local institution lab) or corrected to within normal limits with supplements prior to the first dose of study medication
- •a. Potassium (WNL)
- •b. Magnesium (WNL)
- •c. Phosphorus (WNL)
- •d. Calcium (WNL)
- •11. Life expectancy of more than 12 months in the absence of any intervention
- •12. Patient has given written, informed consent to participate in the study
- •*Note: One of the PCR tests used to document persistent disease may also serve to document CCyR, if <1% on IS (see Inclusion criteria #4)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior accelerated phase or blast crisis
- •2. Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months)
- •3. Patient has received another investigational agent within last 6 months or TKIs other than imatinib
- •4. Prior stem cell transplantation
- •5. Impaired cardiac function including any one of the following:
- •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 patientre-screened for QTc
- •e. Myocardial infarction within 12 months prior to starting study
- •f. Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension)
- •g. History of or presence of clinically significant ventricular or atrial tachyarrhythmias
- •6. Administration of cytokine therapy (e.g. G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry
- •7. Atypical BCR-ABL transcript not quantifiable by standard RQ-PCR.
- •8. Another primary malignant disease, which requires systemic treatment (chemotherapy or radiation)
- •9. Acute liver disease
- •10. Acute or chronic pancreatic disease
- •11. Another severe and/or life-threatening medical disease
- •12. History of significant congenital or acquired bleeding disorder unrelated to cancer
- •13. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug
- •14. Patients actively receiving therapy with strong CYP3A4 inhibitors and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug
- •15. Patients who are currently receiving treatment with any medications that have 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
- •16. Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (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)
- •17. Interruption of imatinib therapy for a cumulative period in excess of 21 days in the preceding 3 months
- •18. Major toxicity on imatinib in past 3 months
- •19. History of non-compliance or inability to grant informed consent
研究者
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