EUCTR2005-002823-15-GB进行中（未招募）1 期
A PHASE I/II TRIAL OF THE USE OF SIROLIMUS (RAPAMUNE) AND LOW DOSE ARA-C IN OLDER PATIENTS WITH ACUTE MYELOID LEUKAEMIA (AML) - Ara-C and Sirolimus in AM
ottingham University Hospitals NHS Trust0 个研究点目标入组 0 人开始时间: 2005年8月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 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
- •All patients must be over the age of 60 years and have AML as defined by the WHO classification or MDS with a blast count of >10% according to WHO criteria (2000):
- •- Patients who are clinically ineligible for induction chemotherapy
- •- Patients with AML that has failed to remit with low dose Ara-C-based regimens or with intensive therapy
- •- Patients with relapsed AML following conventional intensive chemotherapy or low dose Ara-C-based regimens
- •Patients must have a life expectancy of greater than 2 months
- •Patients must have understood and voluntarily signed the approved informed consent form
- •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
- •Patients with acute promyelocytic leukaemia (FAB M3)
- •Patients in blast transformation of chronic myeloid leukaemia
- •Patients with concurrent active malignancy
- •Patients who have received a non-licenced drug within 1 month of entering the trial
- •ECOG performance score of 4
- •Severe hepatic impairment: Childs-Pugh score C
- •Patients already known to be HIV positive
- •Patients who have had a previous bone marrow or stem cell transplant
研究者
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