EUCTR2014-000098-38-FR进行中（未招募）1 期
A phase II trial of SGI-110 in patients with ipss high and int 2 myelodysplastic syndrome, acute myeloid leukemia with 20-30% marrow blasts and chronic myelomonocytic leukemia type 2 not responding to azacitidine or decitabine after at least 6 courses or relapsing after a response
Groupe Francophone des Myélodysplasies (GFM)0 个研究点目标入组 54 人开始时间: 2014年2月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 54
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
- •1. Myelodysplastic syndrome including the following categories of the WHO classification: refractory anemia with excess blasts (RAEB), non-proliferative chronic myelomonocytic leukemia (CMML) (leukocytes < 13 G/L but > 10% marrow blasts), AML with 20-30% marrow blasts (RAEB-T according to the FAB classification), at screening time.
- •2. Prior treatment with azacitidine or decitabine for at least 6 courses without response
- •(CR, PR, marrow CR or stable disease with HI according to IWG 2006 criteria) or relapsing after a response. Non responders will be eligible only in the absence of overt progression, ie AML progression (if patients had no AML at onset of azacitidine/decitabine) or doubling of marrow blast percentage between onset of azacitidine/decitabine and screening
- •3. IPSS score >1 (IPSS: Int-2 or High).
- •4. Age = 18 years.
- •5. Normal liver function, defined by total bilirubin and transaminases less than 1.5 times the upper limit of normal.
- •6. Normal renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance = 50 mL/min (according to MDRD formula rather than Cockroft formula in patients older than 65 years) .
- •7. Patient is known not to be refractory to platelet transfusions.
- •8. Written informed consent.
- •9. Patient must understand and voluntarily sign consent form.
- •10. Patient must be able to adhere to the visit schedule as outlined in the study and follow protocol requirements.
- •11. ECOG performance status between 0-2 at the time of screening.
- •12. Women of childbearing potential must: Agree to use effective contraception without interruption throughout the study and for a further 2 months after the end of treatment.
- •13. Men must: Agree to not conceive during the treatment and to use effective contraception during the treatment period (including periods of dose reduction or temporary suspension) and for a further 2 month after the end of treatment if their partner is of childbearing potential.
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1. Severe infection or any other uncontrolled severe condition.
- •2. Significant cardiac disease - NYHA Class III or IV or having suffered a myocardial infarction in the last 6 months.
- •3. Less than 30 days since prior treatment with growth factors (EPO, G-CSF).
- •4. 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.
- •5. Active cancer, or cancer during the year prior to trial entry other than basal cell carcinoma, or carcinoma in situ of the cervix or breast.
- •6. Patient already enrolled in another therapeutic trial of an investigational drug.
- •7. HIV infection or active hepatitis B or C.
- •8. Women who are or could become pregnant or who are currently breastfeeding.
- •9. Any medical or psychiatric contraindication that would prevent the patient from understanding and signing the informed consent form.
- •10. Patient eligible for allotransplantation.
- •11. Known allergy to SGI-110 or any of its excipients.
- •12. No affiliation to an insurance system.
研究者
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