Four Years Experience With Hyper-CVAD Treatment of Adult T-cell Acute Lymphoblastic Leukemia in Sweden. Population-based Data.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Hyper-CVAD (a chemotherapy regimen) has shown promising results in adult T-cell Acute Lymphoblastic Leukemia (T-ALL). Patients with T-ALL diagnosis were reported to the Swedish Adult Acute Leukemia Registry between October 2002 and September 2006. Hyper-CVAD was recommended to all patients without severe comorbidity. Allogeneic stem cell transplantation was recommended for patients with high-risk disease. The aim of this population-based study was to assess the efficacy of Hyper-CVAD treatment.
详细描述
Patients with T-ALL diagnosis were prospectively reported to the Swedish Adult Acute Leukemia Registry between October 2002 and September 2006. Missing data were complemented retrospectively. Hyper-CVAD (fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with cycles of high-dose methotrexate and cytarabine) was recommended to all patients without severe comorbidity. Allogeneic stem cell transplantation (SCT) was recommended for patients with high-risk disease: white blood cell count >100×109/L, complete remission (CR) achievement after more than two courses, high minimal residual disease level, and relapsed disease (after CR2 achievement). In patients without high-risk factors maintenance therapy was given with per oral mercaptopurine and methotrexate for two years including reinduction courses: daunorubicine, vincristine and prednisolone every second month (1st year) and cytarabine, thioguanine and prednisolone every third month (2nd year).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients with T-ALL diagnosis
排除标准
- 未提供
结局指标
主要结局
overall survival
时间窗: The outcome was assesed from T-ALL diagnosis to date of death or last follow-up (up to 125 months). Diagnosis was made between October 2002 and September 2006. All surviving patients were followed up until February 2013.
Overall survival was defined as time from T-ALL diagnosis to the date of death from any cause or the date of last follow-up. All events (death/relapse) were reported prospectively to the the swedish acute leukemia registry. Inclusion Criteria: All patients with T-ALL diagnosis. Exclusion Criteria: No
次要结局
- leukemia free survival(The outcome was assesed from T-ALL diagnosis to date of death or last follow-up (up to 125 months). Diagnosis was made between October 2002 and September 2006. All surviving patients were followed up until February 2013.)
研究者
Piotr Kozlowski
MD
Region Örebro County