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临床试验/EUCTR2008-002260-33-DE
EUCTR2008-002260-33-DE进行中（未招募）1 期

A Phase II Study of Dasatinib Therapy in Children and Adolescents with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or with Ph+ Leukemias Resistant or Intolerant to Imatinib Decision number of Paediatric Investigation Plan: P/31/2010 & P/200/2011 + P/0118/2013

Bristol Myers Squibb International Corporation0 个研究点目标入组 145 人开始时间: 2010年12月29日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
入组人数
145
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) Signed Written informed consent from subject, or from parents minor subjects, according to local law and regulation.
  • •2) Target Population
  • •a) Diagnosis:
  • •i) Cohort #1: Subjects must have Ph+ CML in CP which presence of all the following criteria:
  • •(a) < 15% blasts in peripheral blood and bone marrow
  • •(b) < 20% basophils in peripheral blood
  • •(c) < 30% blasts + promyelocytes in peripheral blood and bone marrow
  • •(d) = 100 X 109 platelets/L unless thrombocytopenia secondary to recent treatment
  • •(e) No extramedullary involvement other than liver and/or spleen
  • •(f) Ph+ (with 9:22 translocation) must be demonstrated by bone marrow cytogenetics
  • •ii) Cohort #2: Subjects must have Ph+ ALL or Ph+ AP- or Ph+ BP-CML:
  • •(1) Ph+ ALL have to be in first or subsequent relapse [defined as loss of a complete hematologic response as defined in Section 4.3.1.1] or fail to achieve a complete hematological remission [as defined in Section 4.3.1.1].
  • •(2) Ph+ AP-CML must meet at least one of the following criteria:
  • •(a) = 15% but < 30% blasts in peripheral blood or bone marrow
  • •(b) = 30% blasts + promyelocytes in peripheral blood and in bone marrow
  • •(but percent alone has to be < 30%)
  • •(c) = 20% basophils in peripheral blood or bone marrow
  • •(d) < 100 X 109/L platelets unrelated to therapy
  • •(3) Ph+ BP-CML has to meet either of the following criteria:
  • •(a) = 30% blasts in peripheral blood or bone marrow
  • •(b) Presence of extramedullary blastic disease other than lymph nodes, liver or spleen
  • •iii) Cohort #3: Subjects must have been newly diagnosed with Ph+ CML in CP which is defined by the presence of all the following criteria:
  • •(a) < 15% blasts in peripheral blood and bone marrow
  • •(b) < 20% basophils in peripheral blood
  • •(c) < 30% blasts + promyelocytes in peripheral blood and bone marrow
  • •(d) = 100 X 109 platelets/L unless thrombocytopenia secondary to recent
  • •(e) No extramedullary involvement other than liver and/or spleen
  • •(f) Ph+ (with 9:22 translocation) must be demonstrated by bone marrow cytogenetics
  • •b) Subjects in Cohort #1 or Cohort #2 have to be proven resistant or intolerant to
  • •i) Intolerance Definition: Cohort #1 and Cohort #2, intolerance to imatinib is defined as the occurrence of any toxicity grade = 3 considered at least possibly related to imatinib and that led to discontinuation of previous imatinib therapy.
  • •ii) For Cohort #1, resistance to imatinib must meet at least one of the following criteria:
  • •(a) Failure to achieve, or loss of, CHR after = 3 months of imatinib at a daily dose of 260 mg/m2 or greater (refer to Section 4.3.2 for CHR loss criteria). Capping the dose at 400 mg QD in chronic phase CML subjects with a BSA > 1.5 m2 is accepted.
  • •(b) Failure to achieve MCyR after = 6 months of imatinib therapy at a daily dose of 260 mg/m2 or greater. (refer to Section 4.3.1.2 for cytogenetic response definitions) Capping the dose at 400 mg QD in chronic phase CML subjects with a BSA > 1.5 m2 is accepted;
  • •(c) Failure to achieve CCyR after = 12 months of imatinib therapy at a daily dose of 260 mg/m2 or greater. (refer to Section 4.3.1.2 for cytogenetic response definitions) Capping the dose at 400 mg QD in chronic phase CML subjects with a BSA > 1.5 m2 is accepted;
  • •(d) Absolute increase of = 30% of the percentage of Ph+ metaphases, confirmed at 2 - 4 weeks, after prior MCyR to imatinib at a daily dose of 260 mg/m2 or greater. Capping the dose at 400 mg QD in chronic phase CML subjects with a BSA > 1.5 m2 is accepted.
  • •iii) For Cohort #2, resistance to i

排除标准

  • •1) Sex and Reproductive Status
  • •a) WOCBP who are unwilling or unable to use a highly effective method to avoid
  • •pregnancy for the entire study period and for up to 1 month after the last dose of
  • •investigational product.
  • •b) Women who are pregnant or breastfeeding or likely to become pregnant
  • •c) Women with a positive pregnancy test on enrollment or prior to investigational
  • •product administration.
  • •d) Sexually active fertile men not using effective birth control if their partners are
  • •WOCBP who are unwilling or unable to use an acceptable method to avoid
  • •pregnancy for the entire study period and for up to 4 weeks after the last dose of
  • •investigational product.
  • •2) Target Disease Exceptions
  • •a) Subjects for whom potentially-curative therapy is available, including
  • •hematopoietic stem-cell transplantation (HSCT) at the time when subject is
  • •assessed for enrollment
  • •b) Subjects with isolated central nervous system disease are excluded from study.
  • •Subjects with CNS-1 (no detectable blast cells in a sample of cerebrospinal fluid),
  • •CNS-2 (< 5 leukemic blast cells in a sample with < 10 erythrocytes per cubic
  • •millimeter) and CNS-3 disease (> 5 leukemic blasts per cubic millimeter in a
  • •sample with < 10 erythrocytes per cubic millimeter) are eligible for study,46
  • •provided this is a combined relapse which also involves the bone marrow in
  • •addition to CNS and they are asymptomatic (no convulsions or other neurological
  • •c) Isolated extramedullary disease, with < 5% blasts in bone marrow
  • •3) Medical History and Concurrent Diseases
  • •a) Any serious uncontrolled medical disorder that would impair the ability of the
  • •subject to receive protocol therapy, including:
  • •i) Ongoing uncontrolled infection
  • •ii) Clinically-significant disorder of platelet function (eg. von Willebrand’s
  • •disease) or ongoing gastrointestinal bleeding
  • •iii) Clinically-significant cardiovascular disease, congenital long QT syndrome,
  • •history of ventricular arrhythmias or heart block, or prolonged QTc interval
  • •> 450 ms (Fridericia correction) on baseline electrocardiogram
  • •iv) Subjects diagnosed with the T315I mutation (mutation testing should be
  • •performed according to the investigator’s standard practice and is not
  • •mandatory at sites without BCR-ABL testing available).
  • •v) Subjects who have experienced hypersensitivity to dasatinib or to any of the
  • •excipients. Inactive ingredients in dasatinib tablets include: lactose
  • •monohydrate, microcrystalline cellulose, croscarmellose sodium,
  • •hydroxypropyl cellulose, and magnesium stearate. The tablet coating consists
  • •of hypromellose, titanium dioxide, and polyethylene glycol.
  • •vi) Subjects with hereditary problems of galactose intolerance or Lapp lactase
  • •deficiency or glucose-galactose malabsorption.
  • •vii)Uncorrected hypokalemia or hypomagnesemia.
  • •b) Expected non-compliance to protocol schedule or unable to have regular
  • •follow-up due to psychological, social, familial or geographic reasons
  • •4) Prohibited Treatments and/or Therapies
  • •a) Prior therapy with dasatinib.
  • •b) Any investigational agent or any other anti-cancer agent within 14 days prior to
  • •treatment start.
  • •i) Imatinib mesylate may be continued up to 7 days before treatment start, or, in
  • 另有 5 项未显示

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