NCT00909168已完成2 期
Induction, Consolidation and Intensification Therapy for Patients Younger Than 66 Years With Previously Untreated CD33 Positive Acute Myeloid Leukemia (AML)
University Hospital, Udine, Italy1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2008年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- RFS, DFS and OS.
研究概览
简要总结
This is a prospective, open, non-randomized, non-controlled, phase II, clinical trial for treatment of newly diagnosed AML patients, younger than 66 years.
Trial is based on:
- INDUCTION: FLAI + Gemtuzumab-Ozogamicin (FLAI-GO).
- CONSOLIDATION: Intermediate dose AraC + IDA (IDAC+IDA) +/- one course of high dose AraC (HDAC)
- INTENSIFICATION: Allo-BMT, ASCT
- MAINTENANCE: AraC
a) Primary endpoints:
- Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
- RFS, DFS and OS.
b) Secondary endpoints:
- Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.
- Evaluation of prognostic clinical relevance of biological features at onset.
- Feasibility and outcome of consolidation with BMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years.
- •WHO PS grade 0-2 (Appendix B) or Karnofsky >
- •AML according to the new WHO criteria, i.e., % of BM blasts ≥ 20%. NB. this % should be assessed on a BM aspiration or on a BM biopsy
- •All FAB subtypes except M
- •CD33 positivity (> 20%). It is mandatory to perform an immunotyping of the BM blasts in particular the determination of CD33 positivity, which will be used as a inclusion factor.
- •Previously untreated (except ≤ 14 days of Hydroxyurea) primary or secondary AML (including AML after MDS).
- •Adequate renal and liver function, i.e., creatinine < 2 mg/dl and bilirubin, ALT/AST ≤ 3 times the upper limit of normal.
- •Written informed consent
排除标准
- •Blast crisis of chronic myeloid leukemia.
- •AML supervening after other myeloproliferative diseases.
- •AML de novo or secondary previously pretreated.
- •Concomitant malignant disease.
- •Active central nervous system (CNS) leukemia.
- •Active uncontrolled infection [NB severe systemic infection should be excluded].
- •Concomitant severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease.
- •Cardiac ejection fraction of 50% or less.
- •Severe pulmonary dysfunction (CTC grade 3-4).
- •Severe concomitant neurological or psychiatric disease.
- •History of alcohol abuse.
- •HIV positivity.
- •Pregnancy.
- •Man and woman not agreeing to the adequate contraceptive precautions during study period and for at last 24 months after stop of therapy.
- •Any psychological, familiar, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
研究组 & 干预措施
Efficacy of FLAIMy
Experimental
干预措施: FLAIMy - Fluda, Ida, Ara-C, Mylotarg (Drug)
结局指标
主要结局
RFS, DFS and OS.
时间窗: one year
Feasibility, Efficacy (CR+PR rate) and Toxicity of FLAI + Gemtuzumab-Ozogamicin.
时间窗: one year
次要结局
- Evaluation of Minimal Residual Disease by WT1 (and other biologic markers) expression and monitoring.(one year)
- Evaluation of prognostic clinical relevance of biological features at onset.(one year)
- Feasibility and outcome of consolidation with BMT.(one year)
研究者
CANDONI ANNA
Division of Hematology, SM MISERICORDIA HOSPITAL
University Hospital, Udine, Italy
研究点 (1)
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