CTRI/2012/10/003047已完成3 期
Extending molecular responses with Nilotinib in newlydiagnosed chronic myeloid leukemia (CML) patients inchronic phase - ENESTxtnd
ovartis Healthcare Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Male or female patients age more than or equal to 18 years old;
- •2. Patients with CML-CP within 6 months of diagnosis (date of initial diagnosis is the date
- •of first cytogenetic analysis). Standard conventional cytogenetic analysis must be done on
- •bone marrow. FISH cannot be used.
- •3. Diagnosis of Chronic Myeloid leukemia in Chronic Phase (CML-CP) with cytogenetic
- •confirmation for the presence of Philadelphia chromosome (9;22 translocation); less than
- •20 metaphases may be used for diagnosis;
- •4. Patients who are considered Ph negative because they do not have a confirmed cytogenetic
- •diagnosis of Philadelphia chromosome are eligible if they have no Ph+ chromosome (9;22
- •translocation) in more than or equal to 20 metaphases and are positive for BCR-ABL transcripts by PCR;
- •5. Patients with atypical BCR-ABL transcripts are eligible (transcripts other than b2a2 and
- •6. No previous treatment with any antileukemic drugs with the exception of hydroxyurea
- •(HU), and/or anagrelide. In emergent cases where the patient requires disease
- •management while awaiting study start, commercial supplies of Gleevec/Glivec at any
- •dose may be prescribed to the patient but for no longer than 2 weeks in duration;
- •7. ECOG 0,1 or 2;
- •8. Normal serum levels more than LLN (lower limit of normal) or corrected to within normal limits
- •with supplements, prior to the first dose of study medication, of potassium, magnesium
- •and calcium;
- •9. AST and ALT more than or equal to 2.5 x ULN or more than or equal to 5.0 x ULN if considered due to leukemia;
- •10. Alkaline phosphatase more than or equal to 2.5 x ULN unless considered due to leukemia;
- •11. Total bilirubin more than or equal to 1.5 x ULN;
- •12. Serum lipase and amylase more than or equal to 1.5 x ULN;
- •13. Written informed consent prior to any study procedures being performed.
排除标准
- •Treatment with tyrosine kinase inhibitors or other antileukemic agents or treatments
- •(including HSCT) for longer than 2 weeks, with the exception of HU and/or anagrelide
- •2. Previously documented T315I mutations;
- •3. Uncontrolled congestive heart failure or hypertension;
- •4. Myocardial infarction or unstable angina pectoris within past 12 months;
- •5. Significant arrhythmias, including history or presence of clinically significant ventricular
- •or atrial tachyarrhythmias, clinically significant bradycardias, long QT syndrome and/orQTc 450 msec on screening ECG (using the QTcF formula). Patients with complete
- •6. History of confirmed acute or chronic pancreatitis;
- •7. Other concurrent uncontrolled medical conditions (e.g. uncontrolled diabetes, active or
- •uncontrolled infections, acute or chronic liver and renal disease) that could cause
- •unacceptable safety risks or compromise compliance with the protocol;
- •8. Impaired gastrointestinal function or GI disease that may alter the absorption of study drug
- •(e.g. ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption
- •syndrome, small bowel resection or gastric by-pass surgery);
- •9. Patients with another primary malignancy that is currently clinically significant or requires
- •active intervention;
- •10. 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 (See link for complete list:
- •http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm);
- •11. Patients actively receiving therapy with strong CYP3A4 inhibitors (e.g., erythromycin,
- •ketoconazole, itraconazole, clarithromycin, telithromycin, ritonavir, mibefradil) and the
- •treatment cannot be either discontinued or switched to a different medication prior to
- •starting study drug (See link for complete list:
- •http://medicine.iupui.edu/flockhart/table.htm);
- •12. Patients actively receiving therapy with strong CYP3A4 inducers (e.g., dexamthasone,
- •phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbitol, St. John¡¯s Wart)
- •and the treatment cannot be either discontinued or switched to a different medication prior
- •to starting study drug (See ling for complete list:
- •http://medicine.iupui.edu/flockhart/table.htm);
- •13. History of significant congenital or acquired bleeding disorder unrelated to cancer;
- •14. Patients who have undergone major surgery ¡Ü 2 weeks prior to starting study drug or who
- •have not recovered from side effects of such therapy;
- •15. Patients who are pregnant or breast feeding or adults of reproductive potential not
- •employing an effective method of birth control. (Women of childbearing potential must
- •have a negative serum pregnancy test within 48 hrs prior to administration of nilotinib).
- •Post menopausal women must be amenorrhoic for at least 12 months to be considered of
- •non-childbearing potential. Male and female patients must agree to employ an effective
- •barrier method of birth control throughout the study and for up to 3 months following
- •discontinuation of study drug;
- •16. Treatment with any hematopoietic colony-stimulating growth factors
研究者
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