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临床试验/EUCTR2005-005153-22-DE
EUCTR2005-005153-22-DE进行中（未招募）不适用

An open-label, randomized study of dasatinib vs. high-dose (800 mg) imatinib in the treatment of subjects with chronic phase chronic myeloid leukemia who have had a suboptimal response after at least 3 months of therapy with 400 mg imatinib.Revised Protocol 03, incorporating Administrative Letter 01 and Protocol Amendments 02 (Version 1.0, Dated 29-May-2007), 03 (Version 1.0, Dated 10-Oct-2007) and 04 (version 1.0, dated 10-Apr-08)

Bristol-Myers Squibb International Corporation0 个研究点目标入组 168 人开始时间: 2006年8月31日最近更新:
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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
168
研究概览入排标准研究者记录与标识符相似试验

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) Subjects able to provide written informed consent
  • •2) Available for periodic follow up
  • •3) Life expectancy of at least approximately 3 months
  • •Target population
  • •4) Subjects with Ph+ chronic phase CML who achieved only a suboptimal response (defined as a HR which is monotherapy; a CgR which is 400 mg monotherapy; a PCgR after at least 12 months therapy with imatinib 400 mg monotherapy or less than MMolR with CCgR after at least 18 months therapy with imatinib 400 mg monotherapy). Only subjects who started treatment with imatinib 400 mg monotherapy within 6 months of initial CML diagnosis will be eligible.
  • •5) ECOG performance status (PS) score 0 - 2 (See Protocol Appendix 1)
  • •6) Adequate hepatic function defined as:
  • •- total bilirubin =2.0 times the institutional ULN;
  • •- alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 times the institutional ULN
  • •7) Adequate renal function defined as: serum creatinine =3 times the institutional ULN.
  • •8) Serum Na, K, Mg and total serum Ca or ionized Ca levels must be greater than or equal to the institutional lower limit of normal. Subjects with low K, Mg levels, total serum Ca and/or ionized Ca must be repleted to allow for protocol entry.
  • •Age and Sex
  • •9) Men and women, 18 years of age and older
  • •10) Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.
  • •11) WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study medication.
  • •The following subjects are considered to be eligible for the additional 12 months of
  • •Subjects with a MMolR after initial 12 months of treatment on either dasatinib or
  • •800 mg imatinib. Subjects who obtain their first MMolR at month 12, should have
  • •this response confirmed at month 13 in order to be eligible to the second year of 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
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •Sex and Reproductive Status
  • •1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period of at least one month before and for at least 3 months after completion of study medication.
  • •2) Women who are pregnant or breastfeeding
  • •3) Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • •4) Men whose sexual partners are WOCBP, who are unwilling or unable to use an acceptable method to avoid pregnancy of his partner for the entire study period and for at least 3 months after completion of study medication.
  • •Target Disease Exceptions
  • •5) Subjects eligible for immediate autologous or allogeneic stem cell transplantation.
  • •6) Previous diagnosis of accelerated phase or blast crisis CML
  • •7) Subjects who have previously documented T315I mutation.
  • •Screening for mutation is not required for enrollment onto the protocol.
  • •8) Subjects with a MMolR
  • •9) Subjects with no hematologic response
  • •10) Subjects who lost previously documented CHR, PCgR or CCgR
  • •Medical History and Concurrent Diseases
  • •11) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
  • •12) Uncontrolled or significant cardiovascular disease, including:
  • •a) A myocardial infarction within 6 months
  • •b) Uncontrolled angina within 3 months
  • •c) Congestive heart failure within 3 months
  • •d) Diagnosed or suspected congenital long QT syndrome
  • •e) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
  • •f) Prolonged QTc interval > 500 msec on pre-entry ECG according to Fridericia formula
  • •g) Any history of second or third degree heart block (may be eligible if the subject currently has a pacemaker)
  • •h) Heart rate consistently < 50 beats/minute on pre-entry ECG
  • •i) Uncontrolled hypertension
  • •13) History of significant bleeding disorder unrelated to CML, including:
  • •a) Diagnosed congenital bleeding disorders
  • •b) Diagnosed acquired bleeding disorder within one year
  • •c) Clinically significant bleeding from the GI tract within 6 months
  • •14) Concurrent other malignancies other than CML
  • •Physical and Laboratory Test Findings
  • •15) Intolerance to imatinib 400 mg. Intolerance is defined as occurrence of any of the following at any time during treatment
  • •a) Imatinib-related grade 3 or greater non-hematologic toxicity
  • •b) Imatinib-related grade 4 hematologic toxicity lasting more than 7 days
  • •c) Imatinib-related toxicity leading to imatinib discontinuation or disruption in dosing for >4 weeks
  • •Prohibited Therapies and/or Medications
  • •16) Prior treatment with imatinib at a dose > 400 mg
  • •17) Less than 3 months of prior treatment with imatinib
  • •18) Time from initial diagnosis of CML to start of first imatinib dose > 6 months
  • •19) Subjects with prior stem cell transplantation and/or high dose chemotherapy for CML
  • •20) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including:
  • •- quinidine, procainamide, disopyramide
  • •- amiodarone, sotalol, ibutilide, dofetilide
  • •- erythromycins, clarithromycin
  • •- chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, zyprasidone
  • •- cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
  • •Subjects who have discontinued any of these medications must have a wash-out period of at least 5 days or at least 5 half

研究者

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