Prospective Evaluation of Standard Chemotherapy Regimen of Idarubicin and Cytarabine in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Complete Response (CR) Rate
研究概览
简要总结
The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.
Objectives:
To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.
详细描述
Ara-C and idarubicin are designed to interfere with DNA's (the genetic material of cells) ability to repair itself, causing cancer cells to die.
If you are found to be eligible to take part in this study, you will receive treatment with idarubicin and ara-C for up to 8 cycles. One cycle lasts about 4-5 weeks. Cycles 1 and 2 are called induction therapy, which is used to help induce (cause) a remission. Cycles 3 to 8 are called consolidation therapy, which is a type of high-dose chemotherapy often given as the second phase of a cancer treatment.
After Cycle 1, you will have a brief rest period of a few days, before you move on to Cycle 2. On Day 1 of Cycle 1, you will receive cytarabine by vein as a continuous infusion over 4 days. It will only be 3 days if you are age 60 or older. On Days 1-3 of Cycle 1, you will receive idarubicin by vein over 1 hour once a day.
The dose of the study drugs you receive may be changed to help manage side effects (such as nausea and diarrhea) that you may experience. Medications (given by mouth or by vein), such as Tylenol (acetaminophen), may be given before and during treatment to help decrease the risk of such side effects. The study doctor will specify what these medications are.
You will have blood drawn (about 2 teaspoons) for routine tests about once a week during treatment. Starting on Days 21-28, you will have bone marrow collected every 1-2 weeks to check the status of the disease. Blood (about 2 tablespoons) will also be drawn at least twice a week after each cycle of therapy (beginning about 4-6 weeks from the start of treatment each cycle) to check your blood counts.
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
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible.
- •Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML. They could have received transfusions, hematopoietic growth factors or vitamins. Temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at screening.
- •Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) </= 3x upper limit of normal (ULN)
- •Ability to understand and provide signed informed consent.
排除标准
- •Subjects with Acute Promyelocytic Leukemia (APL).
- •Presence of active systemic infection.
- •Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
- •Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
研究组 & 干预措施
Idarubicin + Cytarabine
Idarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3). Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
干预措施: Cytarabine (Drug)
Idarubicin + Cytarabine
Idarubicin 12 mg/m2 IV over 1 hour daily x 3 (days 1-3). Cytarabine 1.5 g/m2 IV over 24 hours daily on day 1-4 (age <60 years) or days 1-3 (age > 60 years).
干预措施: Idarubicin (Drug)
结局指标
主要结局
Complete Response (CR) Rate
时间窗: Up to 2 months
Complete Response (CR): Normalization of marrow (\< 5% blasts; \>10% cellularity) and of peripheral blood counts (no circulating blasts, neutrophil count \> 109/L, platelet count \> 100 x 109/L).
次要结局
- Event-Free Survival (EFS)(from treatment initiation until treatment failure, relapse, or death)
- Overall Survival (OS)(Until death or loss of follow-up)