Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Efficacy of treatment in adulta with standard risk acute lymphoblastic leukemia
研究概览
简要总结
Understand the dynamics of elimination of MRD in adult patients with standard-risk LAL treated with a pediatric protocol.
详细描述
Induction therapy is administered. Patients experiencing slow response (> 10 % blasts in the 15th mo of treatment) were included in the LAL -AR -03 protocol, on the arm of intensified induction. Those who do not reach the RC will be excluded from the study and will be treated according to the protocol LAL-AR/03 , which will be incorporated receiving blocks consolidation. All patients in CR consolidation treatment (1 and 2 ) followed reinducciones maintenance (maintenance -1 ) to complete the first year of treatment and maintenance without reinducciones (maintenance -2 ) to complete two years from the RC will be administered . If after union persistent high levels of ER ( > 0.05 %) and this reappears later during maintenance therapy the patient will be excluded from the study and will be treated according to the protocol of high risk ( PETHEMA LAL-AR/03 ) . In case of persistent high levels of ER patients after consolidation will consolidate blocks PETHEMA LAL-AR/03 protocol followed by allogeneic HSCT . If the ER reappears during maintenance treatment the patient will receive an allogeneic HSCT , Standby thereof, may be administered one or two blocks consolidation of LAL -AR -03 protocol.
To allow time to better characterize the LLA and thus ensure proper inclusion of patients in the study recommends administering a prephase with :
- Prednisone ( PDN) 60 mg/m2 po or iv through characterization of LAL with a maximum of 7 days.
intrathecal chemotherapy
- Methotrexate (MTX ) : 12 mg
- ARA - C: 30 mg
- Hydrocortisone 20 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age> 15 years) with ALL standard risk previously untreated. The LAL standard risk is defined by all of the following criteria:
- •Age less than 30 years
- •WBC <25x109 / L
- •Absence of cytogenetic alterations that misbehave forecast or t (9, 22) or demonstration of BCR-ABL rearrangement or alterations in 11q23, or demonstration ALL1-AF4 rearrangement (MLL)
排除标准
- •LAL L3 type mature phenotype B (sIg +) or with cytogenetic abnormalities characteristic of Burkitt LAL (t [8, 14], t [2, 8], t [8, 22]). For these patients have the BURKIMAB study.
- •LAL Ph (BCR-ABL) positive. These patients should be treated with imatinib associated with chemotherapy.
- •Biphenotypic acute leukemias and bilinear. For these patients treatment is recommended LAM own guidelines.
- •Acute undifferentiated leukemias. For these patients treatment is recommended LAM own guidelines.
- •Patients with a history of coronary artery disease, valvular or hypertensive heart disease.
- •Patients with chronic liver disease.
- •Patients with chronic respiratory failure.
- •Renal failure not due to the LAL.
- •Severe neurological disorders, not due to the LAL.
- •General State concerned (grades 3 and 4 WHO scale), not attributable to the LAL.
研究组 & 干预措施
Induction and consolidation treatment
干预措施: Vincristine (Drug)
Induction and consolidation treatment
干预措施: Daunorubicin (Drug)
Induction and consolidation treatment
干预措施: Prednisone (Drug)
Induction and consolidation treatment
干预措施: L-asparaginase (Drug)
Induction and consolidation treatment
干预措施: Ciclophosphamide (Drug)
Induction and consolidation treatment
干预措施: Metotrexate (Drug)
Induction and consolidation treatment
干预措施: ARA-C (Drug)
Induction and consolidation treatment
干预措施: Hidrocortisone (Drug)
Induction and consolidation treatment
干预措施: Mercaptopurine (Drug)
Induction and consolidation treatment
干预措施: VP-16 (Drug)
Induction and consolidation treatment
干预措施: Dexametasone (Drug)
结局指标
主要结局
Efficacy of treatment in adulta with standard risk acute lymphoblastic leukemia
时间窗: 2 years
次要结局
未报告次要终点
