PER-058-06已完成未知
RANDOMIZED PHASE III STUDY OF THE INHIBITOR OF FARNESYL TRANSFERASE R115777 IN PATIENTS WITH ACUTE MYELOID LEUKEMIA (AML) IN SECOND OR SUBSEQUENT REMISSION OR IN REMISSION AFTER FAILURE TO THE FIRST INDUCTION OR PATIENTS OVER 60 YEARS IN FIRST REMISSION.
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 个研究点目标入组 0 人开始时间: 2007年1月18日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 0 至 0（—）
入选标准
- •1) Eligible patients must be in one of the following categories: A) Patients in first complete remission followed by failure of primary induction. B) Patients must have received at least two induction therapy regimens. C) Patients in second or subsequent complete remission (CR2).
- •2) Patients must be in CR by haematological and bone marrow studies.
- •3) Patients must have morphological evidence of having AML of one of the following types before entering CR: a) Acute myeloblastic leukemia (MO, M1, M2). b) Acute myelomonocytic leukemia (M4). c) Acute monocytic leukemia (M5). d) Acute erythroleukemia (M6). e) Acute megakaryocytic leukemia (M7). f) Refractory anemia with excess blasts in transformation (RAEB-T)
- •4) Patients with acute promyelocytic leukemia are not eligible.
- •5) Patients must register within 60 days of the end of therapy for the current referral.
- •6) ANC> 1000 / mm3.
- •7) Platelet count> 100,000 / mm3.
- •6) Patients who have received consolidation therapy are eligible.
- •9) Patients who have received an autologous stem cell transplant are eligible.
- •10) Patients who have not received some form of post-remission therapy are eligible.
- •11) Patients who have received an allogeneic transplant in the current remission are not eligible.
- •12) Patients with a history of extramedullary disease are eligible if they are in CR at the time of entering the study and do not require therapy for their extramedullary disease.
- •13) Patients should not be pregnant or breastfeeding.
- •14) Potentially pregnant women and sexually active men should be advised to use an effective contraceptive method.
- •15) Patients should not have known allergy to imidazole, as well as clotrimazole, ketoconazole, miconazole, econazole or terconazole, as they would have an increased risk of allergic reaction to R115777.
- •16) Patients must be over 18 years of age.
- •17) Patients must include the following criteria at the time of recruitment: ECOG Status 0-2.
排除标准
- •1) Active cardiac or pulmonary disease.
- •2) Active kidney disease.
- •3) Active liver disease.
- •4) Patients should not be taking an anticonvulsant inducer of liver enzymes.
研究者
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