EUCTR2004-002504-15-FI进行中（未招募）不适用
A RANDOMIZED PHASE II STUDY COMPARING IMATINIB AND THE COMBINATION OF IMATINIB AND PEGYLATED INTERFERON ALPHA-2B IN NEWLY DIAGNOSED NON-HIGH RISK CHRONIC MYELOID LEUKEMIA PATIENTS IN COMPLETE HEMATOLOGICAL REMISSION AFTER IMATINIB INDUCTION THERAPY - Nordic IR-LR Study
The Nordic CML Study Group0 个研究点目标入组 120 人开始时间: 2004年8月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •1. At least CHR after three months treatment with Imatinib 400 mg/day.
- •2. Age =18 years
- •3. CP1 of less than 6 months duration
- •4. Sokal IR/LR
- •5. Performance status (ECOG) =2
- •6. Written informed consent
- •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
- •1. Less than CHR after 3 months Imatinib treatment.
- •2. Age <18
- •3. Sokal HR
- •4. More than 6 months from diagnosis.
- •5. CP2 or ABP
- •6. Scheduled alloSCT within 1 year from diagnosis.
- •7. Performance status (ECOG) >2
- •8. Inability to provide written informed consent
- •9. Pregnancy
- •10. Formal refusal of any recommendation of a safe contraception
- •11. Alcohol or drug addiction
- •12. Altered hepatic or renal function as defined by ASAT/ALAT or bilirubin > 3 times upper normal limits (UNL) and by creatinine >20mg/L (177 µmol/L)
- •13. Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.
- •14. Participating in another treatment trial.
- •15. Pretreatment with chemotherapy other than HU and agrylin.
- •16. Secondary malignancy if it requires therapy and estimated life expectancy is shorter than median survival of CML.
- •17. Other serious diseases, pregnancy including lactation period or other conditions which could prevent the required protocol compliance.
研究者
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