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临床试验/NCT02036489
NCT02036489已完成4 期

Pethema LAL-RI/2008: Treatment for Patients With Standard Risk Acute

PETHEMA Foundation1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Vincristine (Drug)

Induction and consolidation treatment

Experimental

干预措施: Daunorubicin (Drug)

Induction and consolidation treatment

Experimental

干预措施: Prednisone (Drug)

Induction and consolidation treatment

Experimental

干预措施: L-asparaginase (Drug)

Induction and consolidation treatment

Experimental

干预措施: Ciclophosphamide (Drug)

Induction and consolidation treatment

Experimental

干预措施: Metotrexate (Drug)

Induction and consolidation treatment

Experimental

干预措施: ARA-C (Drug)

Induction and consolidation treatment

Experimental

干预措施: Hidrocortisone (Drug)

Induction and consolidation treatment

Experimental

干预措施: Mercaptopurine (Drug)

Induction and consolidation treatment

Experimental

干预措施: VP-16 (Drug)

Induction and consolidation treatment

Experimental

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

研究者

发起方
PETHEMA Foundation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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