NCT00002945已完成3 期
High-Dose Cytarabine and Idarubicin Induction, High Dose Etoposide and Cyclophosphamide Intensification, Autologous Stem Cell Transplantation and Interleukin-2 Immune Modulation in Previously Untreated De Novo and Secondary Adult Myeloid Leukemia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation.
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells.
PURPOSE: Phase III trial to study the effectiveness of high-dose combination chemotherapy, peripheral stem cell transplantation, and interleukin-2 in treating patients who have acute myeloid leukemia.
详细描述
OBJECTIVES:
- Determine relapse free survival of patients with previously untreated de novo or secondary acute myeloid leukemia treated with high dose cytarabine and idarubicin induction, high dose etoposide and cyclophosphamide intensification, filgrastim (G-CSF), melphalan, radiotherapy, autologous peripheral blood stem cell (PBSC) transplantation, and interleukin-2.
- Correlate remission rate and relapse free survival with multidrug resistance phenotype in patients treated with this regimen.
- Determine stem cell content and presence of cells with leukemia specific markers in PBSC harvested following high dose etoposide and cyclophosphamide intensification.
- Correlate NK cell expansion (an increase in both proportion and absolute number) during interleukin-2 therapy following autologous PBSC transplantation with disease free survival.
OUTLINE:
Induction
- Patients receive cytarabine IV over 1 hour every 12 hours for 6 days and idarubicin IV over 30 minutes following third, fifth, and seventh doses of cytarabine. Beginning 12 hours after the last dose of cytarabine, patients receive filgrastim (G-CSF) subcutaneously (SQ) each day until blood counts recover.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven de novo or secondary acute myeloid leukemia with a classification of M0-M2 or M4-M7
- •No classification of M3
- •No promyelocytic leukemia
- •Prior medical conditions allowed:
- •Myelodysplastic syndromes
- •Aplastic anemia
- •Paroxysmal nocturnal hemoglobinuria
- •Myeloproliferative disorders except Philadelphia chromosome positive chronic myelogenous leukemia
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Not specified
- •Life expectancy:
- •At least 4 weeks
- •Hematopoietic:
- •Not specified
- •Bilirubin no greater than 2 times normal
- •SGOT no greater than 2 times normal
- •Alkaline phosphatase no greater than 2 times normal
- •Creatinine no greater than 1.5 times normal
- •Cardiovascular:
- •Ejection fraction at least 45%
- •No severe cardiovascular disease including myocardial infarction within past 6 months, uncontrolled symptomatic congestive heart failure, angina pectoris, or multifocal cardiac arrhythmias
- •No uncontrolled diabetes mellitus
- •No other active malignancy
- •No hypersensitivity to E. coli derived drug preparations
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy for acute leukemia except hydroxyurea
- •Prior chemotherapy allowed for other malignancy or other medical condition
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior radiotherapy allowed for other malignancy or other medical condition
- •Not specified
排除标准
- 未提供
结局指标
主要结局
To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation.
时间窗: 24 hours
To determine the efficacy of 4-6 h and 18-24 h, 20% ALA applications on superficial and nodular epidermally-derived lesions using ca633 nm laser irradiation.
次要结局
未报告次要终点
研究者
研究点 (1)
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