NL-OMON30154尚未招募不适用
A phase I clinical trial to study the safety of treatment with Tipifarnib (ZARNESTRA) combined with Bortezomib (VELCADE) in patients with myelodysplastic syndrome (MDS) - Bortezomib and Tipifarnib in MDS
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 18 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 18
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
- •MDS (including the non-proliferative form of CMML, i.e. CMML with a WBC count < 12,0 x 109) /L with < 30% blast cells in the bone marrow and with < 5% circulating blasts).
- •IPSS score: Intermediate Risk-2 or High Risk
- •Age at the time of obtaining informed consent 18 years or older
- •WHO performance status 0-2
排除标准
- •IPSS score: low risk and intermediate-1 category.
- •Candidates for allogeneic stem cell transplantation.
- •Clinical relevant liver (AST/ALT equal to or higer than 1,5 ULN and bilirubin equal to or higher than 2 mg/dl) or renal insufficiency (ECC < 50 %).
- •Significant vascular, pulmonary, gastrointestinal, endocrine, rheumatologic, or metabolic disturbances.
- •Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment.
- •Receipt of extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 8 weeks before enrollment.
- •Having received a stem cell transplantation.
研究者
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