NL-OMON21778招募中不适用
Imatinib in combination with Cytarabine as compared to Imatinib alone in patients with first chronic phase Chronic Myeloid Leukemia. A prospective randomized phase III study.
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl0 个研究点目标入组 330 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
- 招募中
- 发起方
- 入组人数
- 330
研究概览
简要总结
/A
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Newly diagnosed patients with CML in first chronic phase <= 2 months;
- •2. Presence of Philadelphia chromosome or bcr-abl rearrangement;
- •3. Age 18-65 years inclusive;
- •4. WHO performance status <= 2;
- •5. Written informed consent.
排除标准
- •1. CML in accelerated phase or blastic crisis as defined by the WHO criteria;
- •2. Hepatic dysfunction (serum bilirubin >= 2 x N, and/or ALAT >= 4 x N, and/or ASAT >= 4 x N);
- •3. Renal dysfunction (creatinine >= 200 micromol/l or 2.3 mg/dl);
- •4. Severe cardiac dysfunction (NYHA classification II-IV);
- •5. Severe pulmonary or neurologic disease;
- •6. Pregnant or lactating females;
- •7. Patients with a history of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
- •8. Patients known to be HIV-positive;
- •9. Patients with active, uncontrolled infections;
- •10. Previous treatment other than hydroxyurea <= 2 months or imatinib <= 1 month;
- •11. Male and female patients of reproductive potential who are not practicing effective means of contraception.
研究者
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