Clinical and biological evaluation of azacitidine in transfusion-dependent patients with Low and intermediate-1 risk MDS, and low-risk CMML, who are either refractory to or not eligible for treatment with erythropoietin +/- G-CSF

MDSG0 个研究点目标入组 30 人开始时间: 2009年9月21日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•Subjects must satisfy the following criteria to be enrolled in the study:
•Must be >=18 years of age at the time of signing the informed consent form
•MDS at IPSS Low or Int-1, or mixed MDS/MPD; either CMML with < 10% marrow blasts or RARS-T
•Patients with high or intermediate probability for response according to the predictive model2 should be refractory to EPO / darbepoetin (equivalent to > 60 000 U of EPO / week for > 8 weeks) followed by EPO + G-CSF for > 8 weeks, or biosimilar drugs in equipotent doses, or EPO + G-CSF upfront for 8 weeks.
•Patients with low probability for response according to the predictive model, could be included without prior EPO/G-CSF treatment
•Transfusion need >4 units over the last 8 weeks, or >8 units over the last 26 weeks.
•Subject has signed the informed consent document.
•Men and women of childbearing potential must use effective contraception during, and for up to 3 months after treatment.
•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

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•Pregnant or lactating females.
•Patients who are eligible for curative treatment
•Expected survival less than 24 weeks.
•Symptomatic thrombocytopenia / active bleeding
•Patients with JAK-2 positive RARS-T if eligible for new investigational drugs
•Serum biochemical values as follows
•1. Serum creatinine >2.0 mg/dL (177 micromol/L)
•2. Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) >3.0 x upper limit of normal (ULN)
•3. Serum total bilirubin >1.5 mg/dL (26 micromol/L)
•Uncontrolled systemic infection
•Considered not capable of following the study protocol

发起方

MDSG