Contribution to verify the effectiveness of adding granulocyte stimulating factor (G-CSF) to therapy 5 - Azacitidine patients with the high risk Myelodysplastic syndrome. - GA-MDS/ 2013

1st Dep. of Medicine, General University Hospital (VFN) in Prague0 个研究点目标入组 135 人开始时间: 2016年7月26日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•1. Patients indicated for the treatment with Vidaza who are not eligible for haematopoietic stem cell transplantation with:
•- Myelodysplastic syndrome (MDS) second intermediate risk and high-risk (International Prognostic Scoring System, IPSS)
•- Chronic myelomonocytic leukemia without myeloproliferative features (CMML II according to WHO)
•- Acute myeloid leukemia (AML) with 20-30% blasts and dysplasia in several cell lines, according to the classification of WHO,
•2. Patients who signed informed consent;
•3. Patients = 18 years;
•4. Patients without significant comorbidities (eg, comorbidities heart, liver, blood vessels, brain), reducing the chance of survival of less than six months;
•Patients unable to undergo therapy and plan visits, including necessary tests.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•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 50

•1. The presence of other hematological, internal disease that limits survival for less than six months.
•2. Pregnant women or women in lactation period
•3. Man or woman of childbearing age without the willingness to use safe contraception. Details of the method of contraception, see the document Information for the Patient / Informed Consent Form.

发起方

1st Dep. of Medicine, General University Hospital (VFN) in Prague