跳至主要内容
临床试验/NL-OMON30154
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

发起方
niversitair Medisch Centrum Sint Radboud

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