EUCTR2005-000640-91-ES进行中（未招募）不适用
Treatment for acute myeloid leukemia (AML) during its first complete remision with the monoclonal antibody Mylotarg ® (anti-CD33/calicheamicina) pre- and post- autologous transplant of hematopoietic stem cells
Institut de Recerca Hospital Sta. Creu i St. Pau0 个研究点目标入组 20 人开始时间: 2006年5月17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
- 入组人数
- 20
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
- •- Primary or novo patients with acute myeloid leukemia (AML) different thant M3 subtype or acute promyelocytic myeloid leukemia.
- •- Age > 18 and < 60 years
- •- ECOG PS < 3
- •- Patients with complete remision after induction and intensification chemotherapy , without extramedular affectation.
- •- Patients would received induction and intensification treatment according to the detailed summary (7. A. 1)
- •- Expression of CD33 by flow cytometri for at least a 20% of the total.
- •- Absence of the HLA-identic sibs
- •- The patient must be recovered from any grade III/IV toxicity of previous chemotherapy treatment (except alopecia).
- •- Consent informed given
- •- Patient must have at least one of the following high risk relapse factors:
- •cytogenetic alterations, except those that indicate prognosis favourable [t(8;21), inv(16), t(16;16)].
- •Normal Cariotype in less that 20 metaphases, or absence of mitosis at diagnosis.
- •Presence of internal tandem duplication for the FLT3 gen, at diagnosis or at any time during the follow-up
- •Two induction cycles for reaching the first complete remision
- •Presence of minimum residual disease (MRD) detectable through CMF (higher than 0,1% of the bone marrow nucleade cells), conventional cariotypeo, FISH or RCP after the intensification detailed in 7.A.1.2.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Previous autologous or alogenic transplant.
- •- Acute lekemia after a 6 months myeloproliferative process or myelodysplastic syndrome, AML that appears after another cured malignant disease (e.g. Hodgkin disease) and AML due to the treatment with alquilant agents or radiations.
- •- Acute promyelocytic leukemia
- •- Complete remision with more than 2 induction cycles
- •- History of relevant hepatic disease, including occlusive hepatic veno disease
- •during the induction or consolidation treatment
- •- Positive serology for HIV, Hepatitis C or hepatitis B surface antigen.
- •- Active infection at the inclusion in the study.
- •- Life expectancy < 3 months
- •- Pregnancy or Lactation at the inclusion in the study.
- •- Creatinine > 2 mg/dl o bilirrubine > 2 mg/dl, or ALT o AST < 2 x UNL
研究者
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