EUCTR2004-001719-77-GB进行中（未招募）1 期
A Randomized Study of Tipifarnib Versus Best Supportive Care (Including Hydroxyurea) in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) in Subjects 70 Years or older.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
入选标准
- •- 70 years of age or older
- •- Newly diagnosed, de novo or secondary AML
- •- Subject not medically fit for, or does not wish to be treated with, combination induction chemotherapy
- •- Pathologic confirmation of AML (>20% bone marrow leukemic blasts)
- •- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (recorded on day of randomization)
- •- Subject has signed the informed consent document. Consent may not be given by a legal representative.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •- Previous cytotoxic or biologic treatment for AML
- •- Acute promyelocytic leukemia (APL)
- •- Absolute peripheral blast count >30,000/mm3
- •- Central nervous system leukemia
- •- Serum biochemical values as follows:
- •Creatinine clearance (calculated by Cockcroft-Gault formula) less than 60ml/min
- •Total bilirubin greater than 1.5 times ULN (CTC Grade 1)
- •ALT (alanine transaminase) and AST (aspartate transaminase) greater than 2.5 times ULN (CTC Grade 1)
- •- Uncontrolled systemic infection
- •- Uncompensated disseminated intravascular coagulation or uncontrolled bleeding
- •- Symptomatic neuropathy of grade 2 or worse
- •- Known allergy to imidazole drugs, such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, isoconazole, sulconazole, ticonazole or terconazole
研究者
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