EUCTR2009-013404-32-FR进行中（未招募）不适用
A Phase I/II Multicenter Study of IV Clofarabine In Patients with High-Risk Myelodysplastic Syndrome who have failed Therapy with Azacitidine: the NIDEVOL study - GFM-clo-08
Groupe Francophone des Myélodysplasies (GFM)0 个研究点开始时间: 2009年6月26日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Patients aged 18 years or more with MDS according to FAB classification and intermediate-2 or high IPSS risk scores, or CMML (with WBC < 13 x 109/L and bone marrow blasts > 10%) according to WHO classification, or AML according to WHO classification if less than 30% bone marrow blasts (RAEB-T according to FAB MDS classification)
- •Patients previously treated by azacitidine (Vidaza®) in proven progression, or stable after 6 courses with ongoing transfusion dependent anemia (> 4 RBC units in the 8 weeks preceding inclusion ( as erythroid response in IWG 2006 criteria is reduction of at least 4 RBC units in 8 weeks )
- •Previous biological and or targeted therapies of MDS or AML are allowed if stopped more than 1 month before inclusion.
- •1.ECOG PS = 2.
- •2.Adequate renal and liver function
- •3.Serum creatinine = 110 microM/L in men or 90 microM/L in women. If plasma creatinine level >90- 110microM, then the estimated glomerular filtration rate (GFR) must be > 50 mL/min/1.73 m2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation where Predicted GFR (ml/min/1.73 m2) = 32788x (plasma creatinine level (microM)-1.154 x (age in years)-0.023 x (0.742 if patient is female) x (1.212 if patient is African American)
- •4.Bilirubin < 1.5 x ULN, (except increased unconjugated bilirubin due to dyserythropoiesis)
- •5.Aspartate transaminase (AST)/alanine transaminase (ALT) ?2.5 × ULN and Alkaline phosphatase ? 2.5 × ULN
- •Absence of pregnancy or lactation in female patients (Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment)
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
- •Provided signed written informed consent
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- •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
- •Patients with AML and bone marrow blasts count of 20-30% , if candidates to intensive AML type chemotherapy
- •Known hypersensitivity to clofarabine or excipients
- •Concomitant malignant disease.
- •Active uncontrolled infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Concomitant severe cardiovascular disease, i.e. congestive heart failure (NYHA grade > 3)
- •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results
- •No affiliation to a national insurance scheme directly or to an equivalent system
- •Chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
- •Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute toxicities from any previous therapy.
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