Treatment of High Risk Adult Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 41
- 主要终点
- To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients.
研究概览
简要总结
Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.
详细描述
HR ALL included one or more of the following baseline parameters: age 30-60 yr, WBC count >25x109/L and 11q23 or MLL rearrangements. Induction therapy included vincristine, prednisone and daunorubicin for 4 weeks. In pts with slow cytologic response to therapy (≥10% blasts in bone marrow assessed on d14) intensified induction with high dose ARA-C and mitoxantrone was administered. Early consolidation therapy included 3 cycles with rotating cytotoxic drugs including high-dose methotrexate, high-dose ARA-C and high-dose asparaginase. Pts. with slow cytologic response on d14 or MRD level >0.05% after consolidation were assigned to allogeneic SCT (related or unrelated) and those with standard cytologic response on d14 and MRD level <0.05% after consolidation received 3 additional cycles of delayed consolidation (identical to those of early consolidation) followed by maintenance therapy up to 2yr in CR.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High risk ALL adult patients (age> 15 years)no treated previously
- •High-risk ALL:
- •One or more of the following:
- •Age 30-60 yr.
- •WBC count >25x109/L
- •11q23 or ALL1/AF4
- •Very high-risk ALL:
- •HR ALL and one or the following:
- •Slow cytologic response (>10% blasts in BM on d14 of induction therapy).
- •MRD>0.05% (by flow cytometry) at the end of consolidation
排除标准
- •L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22).
- •ALL Ph (BCR/ABL) positive.
- •Bifenotipics ALL as EGIL criteria.
- •Indifferentiated ALL.
- •Patients with cardiac pathology
- •Patients with chronic liver disease in activity fase
- •Pulmonary disease
- •Renal insufficiency not due to ALL
- •Neurological disorders not due to ALL
- •PS (grades 3 and 4) not due to ALL.
结局指标
主要结局
To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients.
时间窗: 2 years
次要结局
未报告次要终点