EUCTR2009-017178-19-FR进行中（未招募）1 期
A phase I-II study of the efficacy and safety of Idarubicin combined to Azacitidine in int-2 or high risk myelodysplastic syndromes - GFM- Aza-Ida-09
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 56
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
- •-Documented diagnosis of MDS, or CMML with WBC < 13,000/mm3 that meets IPSS criteria for intermediate-2 or high-risk disease,
- •-IPSS score =1.5
- •-Myocardial function does not indicate cons the use of idarubicin
- •-no contra indication to anthracyclines
- •-Age = 18 years
- •-Perfornance Status =2 according to ECOG.
- •-Serum creatinine < 1.5 x ULN and normal levels of electrolytes (serum sodium 136-145 nmmol/l, Potassium 3,5-4,5 mmol/l, alkaline Reserve 23-29 mmol/l, , Calcium 2,15-2,5 mmol/l, Phospohore 0,87-1,45 mmol/l)
- •-Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) < 1.5 x upper limit of normal (ULN)
- •-Serum total bilirubin < 1.5 x ULN.
- •-Non eligible for an allogeneic stem cell transplantation.
- •-Must be able to adhere to the study visit schedule and other protocol requirements
- •-Signed informed consent.
- •Female subjects of childbearing potential† must:
- •Accept effective contraception without interruption throughout the duration of study and up to three months after the end of treatment.
- •Male subjects must
- •Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy and up to three months after the final treatment if their partner is of childbearing potential and has no contraception.
- •Agree to learn the procedures for preservation of sperm
- •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
- •Uncontrolled infection
- •-Prior therapy with anthracycline for MDS.
- •-Prior therapy with demethylating agents within the last 3 months
- •-Prior therapy with Hematopoietic growth factor (ESA or G-CSF) agents or cytotoxic agents (oral chemotherapy, low doses AraC) within the last 30 days.
- •-Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast)
- •-Pregnant or lactating females
- •-Known HIV-1 positivity
- •-Contra-indication to Anthracyclines
研究者
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