EUCTR2008-000664-16-IT进行中（未招募）1 期
Clinical phase II trial to evaluate the safety and efficacyof treosulfan combined with cytarabine and fludarabine prior to autologous haematopoietic stem cell transplantation in elderly patients withAcute Myeloid Leukemia or Myelodysplastic Syndrome. - ND
OSPEDALE S. RAFFAELE0 个研究点目标入组 15 人开始时间: 2008年2月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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.Patients with de novo or secondary acute myeloid leukemia or with Int 2 or High risk myelodysplastic syndrome, according to IPSS.
- •2.Patients unable or unfit to receive an hematopoietic stem cell transplantation from an HLA-identical related or unrelated, or
- •HLA-haploidentical related donor.
- •3.Hematologic complete remission after 1 or 2 cycles of induction standard chemotherapy.
- •4.Successful collection of autologous peripheral blood hematopoietic stem cells: ≥ 5.0x10e6 /kg patient BW.
- •5.Age ≥ 65 years.
- •6.Performance Status 0-2 ECOG, 60-100% Karnofsky.
- •7.Written informed consent.
- •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
排除标准
- •1.Diagnosis of AML M3.
- •2.Second concomitant malignancies
- •3.Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function)
- •4.Known and manifested malignant involvement of the CNS
- •5.Active infectious disease
- •6.HIV- positivity or active hepatitis infection
- •7.Impaired liver function (bilirubin > 1.5 x upper normal limit; transaminases > 3.0 x upper normal limit)
- •8.Impaired renal function (creatinine-clearance < 60 ml/min; serum creatinine > 1.5 x upper normal limit).
- •9.Pleural effusion or ascites > 1.0 L
- •10.Known hypersensitivity to treosulfan and/or cytarabine and/or fludarabine
- •11.Participation in another experimental drug trial within 4 weeks before day -6
- •12.Non-cooperative behaviour or non-compliance
- •13.Psychiatric diseases or conditions that might impair the ability to give informed consent
研究者
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