NCT01064557Unknown不适用
Guideline for the Treatment of Newly Diagnosed Patients Eith Acutypromyelocytic Leukemia, Aged > 12 Months (1 Year) and <75 Years, Using All-trans Retinoic Acid in Combination With Idarubicin
适应症
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 1,068
- 试验地点
- 94
- 主要终点
- To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.
研究概览
简要总结
The main purposes of the AIDA protocol are to test the role of intermittent maintenance therapy with ATRA, standard maintenance chemotherapy with methotrexate and 6-mercaptopurine of both in PCR negative patients at the end of the consolidation phase and to evaluate the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase.
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
- 1 Year 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 12 months (1 year) and < 75 years
- •Morphological newly diagnosis of APL
- •Presence of the PML-RARa transcript
- •No cardiac contraindications to anthracycline chemotherapy
- •Serum creatinine <=2.5 mg/dL
- •Serum alkaline phosphatase <= 3 times the normal upper limit
- •Serum bilirubin <= 3 times the normal upper limit
- •Serum SGOT <= 3 times the upper normal limit
- •Negative pregnancy test
- •Informed consent
排除标准
- •Age <= 12 months and >=75 years
- •absence of the PML-RARa transcript
- •Pregnant of lactating women
- •Presence of active serious infections that are not controlled by antibiotics
- •Prior treatment with antileukemic therapy (excluded corticosteroids)
- •Presence of severe concomitant psychiatric disease
- •Presence of other concomitant malignant tumors, except basal cell carcinoma
- •Concurrent treatment with cytotoxic chemotherapy or radiotherapy
- •Cardiac contraindications to anthracycline chemotherapy
- •Serum creatinine >2.5 mg/dL
- •Serum alkaline phosphatase > 3 times the normal upper limit
- •Serum bilirubin > 3 times the normal upper limit
- •Serum SGOT > 3 times the upper normal limit
- •Positive pregnancy test
- •Absence of informed consent
结局指标
主要结局
To assess the role of maintenance therapy with ATRA, chemotherapy or both in PCR negative patients at the end of the consolidation phase.
次要结局
- To evaluate the role of maintenance therapy with ATRA and chemotherapy in PCR positive patients at the end of the consolidation phase not eligible for a BMT procedure
- To assess the efficacy, in terms of CR rate, and toxicity of an induction treatment combining ATRA with Idarubicin
- To assess the role of allogeneic or autologous bone marrow transplantation in PCR positive patients at the end of the consolidation phase
研究者
研究点 (94)
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