NL-OMON31003尚未招募3 期
An open label, randomised, muliticentre Phase III Trial of Dasatnib (SPRYCEL®) vs standard dose Imatininb (400mg) in the treatment of subjects with newly diagnosed chronic phase Philadelphia chromosome positive chronic myeloid leukaemia (CML). - CA180-056
Bristol-Myers Squibb0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
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
- 18 至 99（—）
入选标准
- •- Subjects must have Philadephia Chromosome positive CML as defined in section 4.2.1 point 2 of the protocol.
- •- Subjects must be previously untreated for chronic CML (however less than 28 days of prior treatment with imatinib is allowed, refer to 4.2.1 point 3)
- •- Subjects must be enrolled within 90 days of diagnosis of CML, based on cytogenetic testing confirming the presence of the Philadephia Chromosome.
- •- ECOG performance status score 0-2
- •- Adequate hepatic function-refer to protocol section 4.2.1 point 6 for hepatic parameters that need to be met.
- •- Adequate renal function-refer to protocol section 4.2.1 point 7.
- •- Aged 18 years +
- •-Women of child bearing potential (WOCBP) are to use an adequate contraception 4 weeks before the study, throughout the study and for at least 4 weeks after discontinuing from the study.
- •- WOCBP must have a negative serum or urine pregnancy test within 72 hours of the start of the study drug.
排除标准
- •-WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy 4 weeks before the study, throughout the study and for at least 4 weeks after discontinuing from the study.
- •-Women who are pregnant or breastfeeding
- •-Women with a positive pregnancy test at enrolment or prior to study treatment
- •- Men whose sexual partners are WOCBP who are unwilling or unable to use an accepted method of contraception throughout the study and for at least 4 weeks after discontinuing from the study.
- •- A serious uncontrolled medical disorder or active infection
- •- Known pleural effusion at baseline
- •- Uncontrolled or significant heart disease (see section 4.2.2 point 8 for examples)
- •- History of any significant bleeding disorder unrelated to CML (see section 4.2.2 point 9 for examples).
- •- Prior chemotherapy for peripheral stem mobilisation
- •- Prior of concurrent malignancy (see exceptions in section 4.2.2 point 11)
- •- Evidence of digestive dysfunction that would prevent oral administration of study drug.
- •- Any prior treatment with interferon
- •- Any prior treatment with dasatinib
- •- Any other prior systemic treatments with anti- CML activity (see exceptions in section 4.2.2 point 15)
- •- Subjects currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes, refer to section 5.5.1 of the protocol.
- •- Prisoners or subjects who are compulsory detained for treatment of either a psychiatric or physical illness must not be enrolled.
研究者
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