EUCTR2008-007054-35-DE进行中（未招募）不适用
A RANDOMIZED PHASE III STUDY OF IMATINIB DOSE OPTIMIZATION COMPARED WITH NILOTINIB IN PATIENTS WITH CHRONIC MYELOGENOUS LEUKEMIA AND SUBOPTIMAL RESPONSE TO STANDARD-DOSE IMATINIB - Suboptimal Response Study - LASOR Study
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
- 188
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.Male or female, aged = 18 years;
- •2.ECOG Performance Status of 0, 1, or 2 (see Appendix A);
- •3.Ph-positive CML in chronic phase (CP) at study enrollment is defined
- •as follows:
- •<15% blasts in peripheral blood and bone marrow;
- •<30% blasts plus promyelocytes in peripheral blood or bone marrow;
- •<20% basophils in the peripheral blood;
- •=100x 109/L (= 100,000/mm3) platelets;
- •no evidence of extramedullary leukemia involvement, with the exception of hepatosplenomegaly;
- •4.Patients with a suboptimal cytogenetic response to 400 mg of imatinib, defined as follows (cytogenetic analysis to document suboptimal response must have been done within 6 weeks of randomization):
- •No cytogenetic response at = 3 to <6 months (more than 95% Ph+ metaphases)
- •No partial cytogenetic response at = 6 to <12 months of treatment (and at least 36% to 95% Ph+ metaphases on bone marrow); or
- •No complete cytogenetic response at = 12 to <18 months of treatment (and have at least 1% to 35% Ph+ metaphases on bone marrow);
- •Bone marrow karyotyping (BMK) is required on a minimum of 20 metaphases; Confirmation of suboptimal response (SoR) by FISH is allowed if BMK is done outside the screening window up to 4 weeks.
- •5.Patients receiving 400mg/daily imatinib standard dose for at least 3
- •months but no longer than 18 months;
- •6.No prior use of imatinib dose higher than 400 mg daily;
- •7.Previous use of IFN, taken prior to imatinib treatment, is allowed at a
- •maximum of 90 days. There is no time limit if the reason for switch from
- •IFN to imatinib was intolerance.
- •8. Female patients of childbearing potential must have a negative urine pregnancy test within 7 days prior to registration;
- •9.Adults must agree to use an acceptable method of contraception to avoid pregnancy for the duration of the study and for 3 months after study termination;
- •10.The following laboratory result must be present:
- •Creatinine <2.0 X ULN
- •Total bilirubin <1.5 X ULN (< 3.0 X ULN if related to disease);
- •SGOT and SGPT < 2.5 X ULN;
- •Serum lipase =1.5 X ULN;
- •Alkaline phosphatase =2.5 X ULN
- •Serum potassium, phosphorus, magnesium and calcium = lower limit of normality (LLN) or corrected to within normal limits with supplements prior to first dose of study drug;
- •11.Written informed consent prior to any study procedures being performed (see Appendix C).
- •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 including clonal evolution or blast crisis CML;
- •2. Prior therapy with imatinib in combination with any other CML drug other than Hydroxyurea and/or Anagrelide;
- •3. More than 18 months of imatinib therapy;
- •4. Patients who started imatinib therapy more than 12 months after the date of the original diagnosis
- •5. Unable to tolerate imatinib at standard dose (400mg);
- •6. Previous treatment with any other tyrosine kinase inhibitor except Glivec and/or CML therapy other than INF, hydroxyurea, and/or anagrelide
- •7. Patients with myelotoxicity = Grade 2 at the time of randomization,
- •8. Previously documented T315I mutations;
- •9. Achieved prior PCyR or CCyR on imatinib therapy and lost that response before entering the study;
- •10. Impaired cardiac function including one of the following:
- •Long QT syndrome or family history of long QT syndrome
- •Clinically significant resting brachycardia (<50 bpm)
- •QTcF >450 msec on screening ECG (using the QTcF formula). If QTc >450 and electrolytes are not with normal ranges, electrolytes should be corrected and then the patient rescreened for QTc to certify QTc <450 msec
- •Myocardial infarction =12 months prior to the first dose of study drug;
- •Other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, unstable angina, significant ventricular or atrial tachyarrhythmias)
- •11. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug;
- •12. 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;
- •13. 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;
- •14. History of previous acute pancreatitis within one year of study entry or medical history of chronic pancreatitis;
- •15. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture is not required).
- •16. Women who are pregnant, breast feeding or of a childbearing potential without a negative urine pregnancy test at screening. Female patients of childbearing potential unwilling to use effective contraceptive precautions throughout the trial. Post-menopausal women must be ammenorrheic for at least 12 months to be considered of nonchildbearing potential;
- •17. Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention;
- •18. Patients with any other clinically significant medical or surgical condition which, according to investigators' discretion, should preclude participation;
- •19. Use of investigational agent within 28 days prior to enrollment in the study or foreseen use of an investigational agent during the study;
- •20. Patients unwilling or unable to comply with the protocol.
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