A multicenter open randomized phase II study of 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 Nordic Myelodysplastic Syndrom Group0 个研究点目标入组 72 人开始时间: 2012年3月28日最近更新: 2017年10月2日

试验速览

暂无简介。

•18 years of age 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.
•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

•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

发起方

MDSG Nordic Myelodysplastic Syndrom Group