EUCTR2011-001639-21-SE进行中（未招募）1 期
A multicentre open randomized phase II study of the efficacy and safety of azacitidine alone or in combination with lenalidomide in high-risk myeloid disease (high-risk MDS and AML) with a karyotype including del(5q) - Not available
MDSG Nordics Myeloplastics Syndrom Study Group0 个研究点目标入组 72 人开始时间: 2011年9月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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
- •Subjects must satisfy the following criteria to be enrolled in the study (del(5q) confirmed by FISH in all cases):
- •18 years of age or older at the time of signing the informed consent form.
- •MDS with IPSS Int-2 or High with a karyotype including del(5q).
- •Acute myeloid leukaemia (AML) with multilineage dysplasia and 20-30 % blasts (former RAEB-t) with a karyotype including del(5q).
- •Subject has signed the informed consent form.
- •Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test prior to starting lenalidomide. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive methods; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasecomized partner) while on lenalidomide. WCBP must agree to have pregnancy tests every 4 weeks while on lenalidomide.
- •Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on lenalidomide, when temporarily stopping lenalidomide and 28 days after the last dose of lenalidomide.
- •Note: Refractory and relapsed patients can be included as long as they fulfil the inclusion criteria.
- •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
- •Eligible for upfront allogeneic SCT without prior induction chemotherapy or azacitidine
- •Pregnant or lactating females.
- •Prior therapy with azacitidine
- •Prior therapy with lenalidomide
- •Expected survival less than two months.
- •Acute promyelocytic leukemia (APL)
- •Central nervous system leukemia
- •Serum biochemical values as follows
- •1.Serum creatinine >2.0 mg/dL (177 mmol/L)
- •2.Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transferase (ALT)/serum glutamate pyruvate transaminase (SGPT) >3.0 x upper limit of normal (ULN)
- •3.Serum total bilirubin >1.5 mg/dL
- •Prior allergic reaction to thalidomide
- •Uncontrolled systemic infection
研究者
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