EUCTR2008-002260-33-GB进行中（未招募）1 期
A Phase II Study of Dasatinib Therapy in Children and Adolescents with Ph+ Leukemia with Resistance or Intolerance to Imatinib.Decision number of Paediatric Investigation Plan: P/31/2010 & P/200/2011 + P/0118/2013
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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 treatment
- •(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 imatinib:
- •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 im
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 becomepregnant
- •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
- •pregnancy for the entire study period and for up to 4 weeks after the last
- •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
- •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
- •millimeter) and CNS-3 disease (> 5 leukemic blasts per cubic millimeter
- •sample with < 10 erythrocytes per cubic millimeter) are eligible for
- •provided this is a combined relapse which also involves the bone marrow
- •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
- •history of ventricular arrhythmias or heart block, or prolonged QTc
- •> 450 ms (Fridericia correction) on baseline electrocardiogram
- •iv) Subjects diagnosed with the T315I mutation (mutation testing should
- •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
- •excipients. Inactive ingredients in dasatinib tablets include: lactose
- •monohydrate, microcrystalline cellulose, croscarmellose sodium,
- •hydroxypropyl cellulose, and magnesium stearate. The tablet coating
- •of hypromellose, titanium dioxide, and polyethylene glycol.
- •vi) Subjects with hereditary problems of galactose intolerance or Lapp
- •deficiency or glucose-galactose malabsorption.
- •vii)Uncorrected hypokalemia or hypomagnesemia.
- •b) Expected non-compliance to protocol schedule or unable to have
- •follow-up due to psychological, social, familial or geographic reasons
- •4) Prohibited Treatments and/or Therapies
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研究者
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