NL-OMON47600已完成2 期
A Phase II Study of Dasatinib Therapy in Children and Adolescents with Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or with Ph+ Leukaemias Resistant or Intolerant to Imatinib - CA180-226
Bristol-Myers Squibb0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •1. Diagnosis:
- •Cohort 1: Subjects must have Ph+ CP-CML
- •Cohort 2: Subjects must have Ph+ ALL or Ph+ AP- or BP-CML
- •Cohort 3a: newly diagnosed treatment-naive chronic phase chronic myelogenous
- •leukemia (CP-CML)
- •Cohort 3b: sub-cohort of 30 newly diagnosed treatment-naive chronic phase
- •chronic myelogenous leukemia (CP-CML), who will receive dasatinib powder for
- •oral suspension (PFOS), Subjects in Cohorts 1 and 2 must have proven resistance
- •or intolerance to imatinib
- •(2) Lansky or Karnofsky scale > 50
- •(3) Life expectancy * 12 weeks
- •(4) 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
- •(5) Serum Na, K, Na, HC03, Mg, P and Ca levels within institutional normal
- •limits and AST, ALT, bilirubin, serum creatinine * Grade 2 (NCI CTCAE, Version
排除标准
- •(1) Subjects for whom potentially-curative therapy is available, including
- •hematopoietic stem-cell transplantation (HSCT)
- •(2) Symptomatic central nervous system (CNS) involvement (except if signs and
- •symptoms are from isolated leptomeningeal disease)
- •(3) Isolated extramedullary disease, with < 5% blasts in bone marrow
- •(4) Any serious uncontrolled medical disorder that would impair the ability of
- •the subject to receive protocol therapy
- •(5) Prior therapy with dasatinib
- •(6) 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
- •(7) Subjects requiring ongoing medications which may:
- •-Have a known risk of causing QTc prolongation
- •-Irreversibly inhibit platelet function, or anticoagulants (Does not apply to
- •low-dose heparin for prophylaxis or to heparin flushes for i.v. lines)
- •(8) Sexually active females of child-bearing potential that are unwilling or
- •unable to use an acceptable method to avoid pregnancy.
- •(9) Sexually active fertile malesnot using effective birth control, if their
- •partners are of child-bearing potential.
- •(10) Cohort 3a and b: no prior chemotherapy, immunotherapy, or radiotherapy for
- •CML with the exception of hydroxyurea
研究者
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