RBR-5hzmjx招募中2 期
A Phase II Study of Dasatinib Therapy in Children and Adolescents with Ph+ Leukemiawith Resistance or Intolerance to Imatinib
Bristol-Myers Squibb0 个研究点开始时间: 2011年6月27日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Intervention
入排标准
- 年龄范围
- — 至 18Y（—）
入选标准
- •Written informed consent from subject, or from parents or legal guardians for
- •minor subjects, according to local law and regulation.
- •Cohort #1: Subjects must have Ph+ CML in CP which is defined by the
- •presence of all the following criteria:
- •< 15% blasts in peripheral blood and bone marrow
- •< 20% basophils in peripheral blood
- •< 30% blasts + promyelocytes in peripheral blood and bone marrow
- •>= 100 X 109 platelets/L unless thrombocytopenia secondary to recent
- •No extramedullary involvement other than liver or spleen
- •Ph+ or variant must be demonstrated by bone marrow cytogenetics
- •Cohort #2: Subjects must have Ph+ ALL or Ph+ AP- or BP-CML:
- •Ph+ ALL have to be in first or subsequent relapse [ >= 25% blasts in bone
- •marrow] or fail to achieve remission after imatinib
- •AP-CML must meet at least one of the following criteria:
- •>= 15% but < 30% blasts in peripheral blood or bone marrow
- •>= 30% blasts + promyelocytes in peripheral blood and in bone marrow
- •(but percent alone has to be < 30%)
- •>= 20% basophils in peripheral blood or bone marrow
- •< 10 X 109/L platelets unrelated to therapy
- •BP-CML has to meet all the following criteria:
- •>= 30% blasts in peripheral blood or bone marrow
- •Presence of extramedullary blastic disease other than lymph nodes,
- •liver or spleen
- •Subjects have to be proven resistant or intolerant to imatinib:
- •For both cohorts, 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.
- •For Cohort #1, resistance to imatinib must meet at least one of the following
- •Failure to achieve, or loss of, CHR after >= 3 months of imatinib at a
- •daily dose of 260 mg/m2 or greater;
- •Failure to achieve MCyR after >=6 months or CCyR after >= 12 months of imatinib therapy at a daily dose of 260 mg/m2 or greater;
- •Absolute increase of >= 30% of the percentage of Ph+ metaphases,
- •confirmed at >= 6 week interval, after prior MCyR to imatinib at a daily
- •dose of 260 mg/m2 or greater.
- •For Cohort #2, resistance to imatinib must meet at least one of the following
- •Failure to achieve CHR while on imatinib after a >= 4-week treatment
- •or a >= 50% increase in peripheral blood blasts over a 2-week period
- •Subjects who achieved a CHR subsequently no longer meet the criteria
- •consistently over a consecutive 2-week period while receiving imatinib
- •Absolute increase of >= 30% of the percentage of Ph+ metaphases,
- •confirmed at >= 6 week interval, after prior MCyR to imatinib.
- •Lansky or Karnofsky scale > 50
- •Life expectancy >= 12 weeks
- •Subjects must have recovered to baseline or Grade 1 (NCI CTCAE, version 3.0)
- •from the toxicities (except alopecia) resulting from recent therapies, including
- •chemotherapy, hormonal therapy, immunotherapy, biological therapy or
- •investigational product and radiation therapy.
- •Serum Na, K, NaHC03, Mg, P and Ca levels within institutional normal limits
- •and AST, ALT, bilirubin, BUN or urea, creatinine ? Grade 2 (NCI CTCAE,
- •Version 3.0).
- 另有 6 项未显示
排除标准
- •WOCBP who are unwilling or unable to use an acceptable method to avoid
- •pregnancy for the entire study period and for up to 12 weeks after the last dose of
- •investigational product.
- •Women who are pregnant or breastfeeding
- •Women with a positive pregnancy test on enrollment or prior to investigational
- •product administration.
- •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.
- •Subjects for whom potentially-curative therapy is available, including
- •hematopoietic stem-cell transplantation (HSCT) at the time when subject is
- •assessed for enrollment
- •Subjects with isolated central nervous system disease are excluded from study.
- •This criterion relates to subjects with CNS-3 disease (? 5 leukemic blasts per
- •cubic millimeter in a sample with < 10 erythrocytes per cubic millimeter).
- •Subjects with CNS-1 (no detectable blast cells in a sample of cerebrospinal fluid)
- •and CNS-2 (< 5 leukemic blast cells in a sample with < 10 erythrocytes per cubic
- •millimeter) are eligible for study. Subjects with a combined relapse which also
- •involves the CNS are eligible, provided this is asymptomatic (no convulsions or
- •other neurological symptoms).
- •Isolated extramedullary disease, with < 5% blasts in bone marrow
- •Any serious uncontrolled medical disorder that would impair the ability of the subject to receive protocol therapy, including:
- •Ongoing uncontrolled infection
- •Clinically-significant disorder of platelet function (e.g. von Willebrand’s
- •disease) or ongoing gastrointestinal bleeding
- •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
- •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).
- •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.
- •Subjects with hereditary problems of galactose intolerance or Lapp lactase
- •deficiency or glucose-galactose malabsorption.
- •Expected non-compliance to protocol schedule or unable to have regular followup
- •due to psychological, social, familial or geographic reasons
- •Prior therapy with dasatinib.
- •Any investigational agent or any other anti-cancer agent within 14 days prior to
- •treatment start. Imatinib mesylate may be continued up to 7 days before treatment
- •start, or, in the presence of rising peripheral blast cells, imatinib may be continued up to 2 days before treatment start. If required for control of peripheral blast cells,hydroxyurea, corticosteroids, 6-mercaptopurine or 6-thioguanine may be given up
- •to 2 days before treatment start.
- •Subjects requiring ongoing medications which may:
- •Have a known risk of causing QTc prolongation ii) Irreversibly inhibit platelet function, or anticoagulants (Does not apply to low-dose heparin for prophylaxis or to heparin flushes for i.v. lines)
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