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临床试验/EUCTR2006-001279-39-CZ
EUCTR2006-001279-39-CZ进行中（未招募）不适用

A Phase II Study of Dasatinib (BMS-354825) in Subjects with Chronic or Advanced Phase Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia who are Resistant or Intolerant to Imatinib

Bristol-Myers Squibb International Corporation0 个研究点目标入组 300 人开始时间: 2006年9月5日最近更新:
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适应症

试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
300
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

  • •- Signed written informed consent
  • •- Subjects must have had prior exposure to imatinib and have primary or acquired resistance or intolerance. Subjects can be pretreated with IFN, standard chemotherapy or high-dose chemotherapy and stem-cell transplantation. Imatinib may or may not be their most recent treatment prior to entering this study.
  • •Target population:
  • •Subjects with a myeloproliferative disorder defined as Ph+ CP CML must meet all the
  • •following criteria:
  • •< 15% blasts in PB cells or BM
  • •< 30% blasts + promyelocytes in PB cells or BM
  • •< 20% basophils in PB cells
  • •Platelets = 100,000/mm³ (or less if related to prior drug therapy)
  • •No extra-medullar involvement (except liver or spleen)
  • •Subjects with previous history of AD CML and subjects with clonal evolution (e.g., trisomy 8, der Ph+, iso17q or trisomy 19) are not eligible in this category even if they still meet the criteria for CP as defined above. They are considered in cytogenetic accelerated phase (AP).
  • •2/ AD CML and Ph+ ALL
  • •Subjects with a myeloproliferative disorder defined as Ph+ or BCR-ABL+ AP CML or MyBP CML or LyBP CML or ALL.
  • •Subjects are considered to have AP CML if they meet at least one of the following
  • •At least 15% to < 30% blasts in PB or in BM
  • •A sum of the percent of blasts and promyelocytes in PB or the BM = 30% (with
  • •< 30% blasts alone)
  • •= 20% basophils in PB or BM
  • •Platelets < 100,000/mm³ unrelated to prior drug therapy
  • •Subjects may not have extra-medullary infiltrates of leukemic cells other than in spleen or liver.
  • •In addition, the following subjects will be considered to be part of the AP CML
  • •population even if they do not reach the above threshold values of % blasts in PB or BM for accelerated phase (i.e. chronic phase by hematologic criteria):
  • •Subjects with clonal evolution (e.g. +8, +19, der Ph+, iso17q, but not -Y only)
  • •Subjects with prior episode of AP who achieved a hematologic response and subsequently progressed
  • •- MyBP and LyBP CML
  • •Subjects are considered to have Myeloid or Lymphoid BP CML if they meet at least one of the following criteria:
  • •= 30% myeloid or lymphoid blasts in PB or in BM
  • •Extra-medullary infiltrates of leukemic cells, other than in spleen or liver, with myeloid or lymphoid blast morphology
  • •Subjects with prior episode of BP who achieved a hematologic response and subsequently progressed but do not meet the criteria for BP CML as described above (i.e. in CP or AP by hematologic criteria) will be considered to be part of the BP CML population.
  • •Subjects with asymptomatic leptomeningeal leukemia are eligible. Concomitant intra-techal therapy is allowed.
  • •- Ph+ ALL
  • •Subjects must have received prior imatinib and at least one prior standard
  • •induction ± consolidation chemotherapy regimen and not be eligible for immediate
  • •autologous or allogeneic stem cell transplantation.
  • •There is no minimum % blasts in PB or BM required for recurrent Ph+ ALL.
  • •Subjects with asymptomatic leptomeningeal leukemia are eligible. Concomitant
  • •intra-techal therapy is allowed.
  • •Subjects characteristics
  • •1) ECOG performance status (PS) score 0 – 2 in CP CML subjects
  • •2) ECOG PS score 0 - 3 in AD CML and Ph+ ALL subjects (See protocol Appendix 1)
  • •3) 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
  • •4) Adequate renal function defined as:
  • •- serum creatinine = 1.5 times the insti

排除标准

  • •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 the study medication.
  • •2) WOCBP using a non-effective contraceptive method
  • •3) Women who are pregnant or breastfeeding
  • •4) Women with a positive pregnancy test on enrollment or prior to study drug administration.
  • •5) 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.
  • •Medical History and Concurrent Diseases
  • •6) A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy
  • •7) Uncontrolled or significant cardiovascular disease, including:
  • •A myocardial infarction within 6 months
  • •Uncontrolled angina within 3 months
  • •Congestive heart failure within 3 months
  • •Diagnosed or suspected congenital long QT syndrome
  • •Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointe)
  • •Prolonged QTcF interval > 450 msec on pre-entry ECG
  • •Any history of second or third degree heart block (may be eligible if the subject currently has a pacemaker)
  • •Heart rate consistently < 50 beats/minute on pre-entry ECG
  • •Uncontrolled hypertension
  • •8) History of significant bleeding disorder unrelated to CML, including
  • •Diagnosed congenital bleeding disorder (e.g., von Willebrand’s disease)
  • •Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
  • •Clinically significant bleeding from the GI tract within 6 months
  • •9) Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
  • •Physical and Laboratory Test Findings
  • •10) Evidence of digestive dysfunction that would prevent administration of study therapy
  • •Prohibited Therapies and/or Medications
  • •11) Subjects who received any of the following:
  • •- hydroxyurea within 2 days (unless WBC > 50,000/mm3)
  • •- imatinib, interferon, 6-mercaptopurine or cytarabine within 7 days
  • •- any investigational agent or other antineoplastic agent within 14 days
  • •12) Subjects currently taking drugs that are generally accepted to have a risk of causing Torsade de Pointe (see Protocol Appendix 2)
  • •13) Subjects currently taking drugs that are potent CYP3A4 substrates, inhibitors or inducers (see Protocol Appendixes 3, 4 and 5)
  • •Other Exclusion Criteria
  • •14) Prisoners or subjects who are compulsorily detained

研究者

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