EUCTR2008-006183-11-IT进行中（未招募）不适用
Multicenter, Open-Label, Single Arm Phase II Clinical Trial of Dasatinib in the Treatment of Systemic Mastocytosis (SM) - Dasatinib and systemic mastocytosis
IVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II0 个研究点开始时间: 2009年10月28日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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) A diagnosis of systemic mastocytosis, according to the WHO criteria; 2) A classification of mastocytosis as either aggressive (presence of C-findings) or smouldering/indolent (presence of B-findings) with severe clinical signs or symptoms unresponsive to antimediator treatment; patients with mastocytosis associated with hematologic non mast cell disease (AHNMD) will be included if the two disorders need to be treated independently, as indicated by the Consensus Guidelines 3) Age >18 years old. Fertile men and women must agree to use a medically acceptable form of contraception during the study; 4) A preserved liver and kidney function as assessed by: a) total bilirubin not exceeding 2.0 times the institutional upper limit of normal (ULN); b) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) not exceeding 2.5 times ULN; c) serum creatinine not exceeding 2.0 times ULN.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Pregnancy or breast feeding; 2) Uncontrolled CNS involvement by mastocytosis or other medical disorder that would impair the ability of the subject to receive cytoreductive therapy; 3) Uncontrolled or active significant cardiovascular disease; 4) An altered mental status that would prevent understanding or rendering of informed consent; 5) Clinically significant bleeding from the GI tract within the last 2 months; 6) Current treatment with prednisone at dose >15 mg/day; 7) Current treatment with cytoreductive drug (IFN, 2-CdA or imatinib). Patients can be enrolled in the study if this treatment has been discontinued at least 1 month prior of enrollment.
研究者
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