Evaluation of Safety and Efficacy of Treosulfan-cytarabine-fludarabine (FLAT) Combination Prior to Autologous Stem Cell Transplant (HSCT) in Elderly Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Ciceri Fabio
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Evaluation of disease free survival from first Complete Remission (CR)
研究概览
简要总结
FLAT-Auto is a phase II trial. fludarabine and ARA-C will be combined with the alkylating agent treosulfan (FLAT), to investigate the feasibility and the efficacy of a new regimen, supported with autologous peripheral blood SCT (PBSCT), as final postremission consolidation in AML/MDS elderly patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pts with de novo or secondary AML or with Int 2 or High risk MDS according to IPSS.
- •Pts unable or unfit to receive SCT from an HLA (human leukocyte antigen)-identical related (SIB) or unrelated (MUD), or HLA-haploidentical related (HAPLO) donor.
- •Hematologic CR (Appendix D) after 1 or 2 cycles of induction standard chemotherapy.
- •Successful collection of autologous PBSC: ≥ 5.0x10e6 /kg patient bodyweight (BW)
- •Age ≥ 65 years.
- •Performance status 0-2 ECOG (Eastern Cooperative Oncology Group), 60-100% Karnofsky (Appendix E).
- •Written informed consent.
排除标准
- •Diagnosis of AML M
- •Second concomitant malignancies.
- •Severe concomitant illnesses/medical conditions (e.g. impaired respiratory and/or cardiac function).
- •Known and manifested malignant involvement of the central nervous system (CNS)
- •Active infectious disease
- •HIV- positivity or active hepatitis infection
- •Impaired liver function (bilirubin > 1.5 x upper normal limit; transaminases > 3.0 x upper normal limit)
- •Impaired renal function (creatinine-clearance < 60 ml/min; serum creatinine > 1.5 x upper normal limit).
- •Known hypersensitivity to treosulfan and/or cytarabine and/or fludarabine
- •Participation in another experimental drug trial within 4 weeks before day -6
- •Non-cooperative behaviour or non-compliance
- •Psychiatric diseases or conditions that might impair the ability to give informed consent
研究组 & 干预措施
FLAT-Auto
Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
干预措施: Fludarabine (Drug)
FLAT-Auto
Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
干预措施: ARA-C (Drug)
FLAT-Auto
Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
干预措施: Treosulfan (Drug)
FLAT-Auto
Treosulfan in a combination regimen with ARA-C and fludarabine as conditioning therapy prior to autologous PBSCT
干预措施: Peripheral Blood Stem Cell Transplant (Procedure)
结局指标
主要结局
Evaluation of disease free survival from first Complete Remission (CR)
时间窗: 2 years after transplantation
Evaluation of disease-free survival (DFS) duration from documented first CR of AML or MDS with intermediate 2 or high IPSS (International Prognostic Score System).
次要结局
未报告次要终点
研究者
Ciceri Fabio
Head of Hematology and Translplant Unit
IRCCS San Raffaele