NCT01064570Unknown2 期
Guidelines for Treatment of Acute Promyelocytic Leukemia
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- Treatment-related toxicity event rate during the ATRA-including consolidation treatment
研究概览
简要总结
Prospective use of RT-PCR for PML/RARa might be used to guide a total tehrapy approach in APL, including refined diagnosis, front-line treatment, assessment of response and anticipated salvage therapy for patients who undergo molecular relapse.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 1 years and < 61 years
- •Morphologic diagnosis of APL
- •Presence in leukemic cells at diagnosis of t(15;17), and/or PML/RARa rearrangement by RT-PCR. T
- •The presence of additional cytogenetic lesions is not considered an exclusion criterion
- •Serum creatinine <=2.5 mg/dL
- •Serum bilirubin, alkaline phosphatase, or GOT/ASAT <= 3 times the upper normal limit
- •Negative pregnancy test
- •Written informed consent
排除标准
- •Age >= 61 years
- •Prior antileukemic chemotherapy for APL
- •Absence of PML-RARa rearrangement after successful RNA extraction and amplification of control gene
- •Prior antileikemic chemotherapy for APL
- •Presence of a concomitant malignant neoplasm, except basal cell carcinoma Concurrent treatment with cytotoxic chemotherapy or radiotherapy
- •Oteher progressive malignant disease. However, secondary acute promyelocytic leukemia following "cured" Hodgkin's disease or otehr cured malignancies may be included, as well as secondary leukemias following other exposure to alkylating agents or radiation for other reasons
结局指标
主要结局
Treatment-related toxicity event rate during the ATRA-including consolidation treatment
时间窗: At the end of the study
次要结局
- The overall toxicity of induction, consolidation, and maintenance chemotherapy in each risk group(At the end of the study)
- The impact on survival of a "total" treatment approach for APL including molecular evaluation of minimal residual disease and salvage tehrapy administration at the time of molecular or hematological relapse(At the end of the study)
- The rates of molecular remission, after consolidation, in each risk group(At the end of the study)
- Event Free Survival, Molecular and Hematological Disease-Free and Overall Survival in each risk group(At the end of the study)
- Induction morbidity and mortality after the inclusion of the prophylactic measures for the ATRA Syndrome and hemorrhagic complications(At the end of the study)
研究者
研究点 (5)
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