2024-514243-29-01招募中3 期
CAALL-F01: a French protocol for the treatment of acute lymphoblastic leukemia (ALL) in children and adolescents
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,636
- 试验地点
- 1
- 主要终点
- o Adequate asparaginase activity (>100 IU/L) at D33 of induction o Toxicity: Incidence of severe toxicities (Grade ≥ 3) directly asparaginaserelated (CNS thrombosis, pancreatitis, anaphylaxia, and hyperbilirubinemia) between D12 and D49 of treatment and anyway before D8 of consolidation
研究概览
简要总结
- For children and adolescents with standard or medium risk ALL, the study has two primary objectives: 1) to assess the superiority in terms of PK at D33 of the fractionated scheme; 2) to assess the equivalence in the tolerance of the 2 schemes (from D12 of induction to D49)
- In the High/Very High Risk group two primary objectives have been defined:
- to assess the PK at D33; 2) to assess the toxicity of the intensified scheme from D12 of induction to D49
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •· Children and adolescents Age > 12 months but < 18 yearsB-lineage or T- lineage ALL · Written informed consent obtained before day 8 of treatment
排除标准
- •· Ph+/BCR-ABL ALL (ESPhALL protocol) · CNS thrombosis before D12
结局指标
主要结局
o Adequate asparaginase activity (>100 IU/L) at D33 of induction o Toxicity: Incidence of severe toxicities (Grade ≥ 3) directly asparaginaserelated (CNS thrombosis, pancreatitis, anaphylaxia, and hyperbilirubinemia) between D12 and D49 of treatment and anyway before D8 of consolidation
o Adequate asparaginase activity (>100 IU/L) at D33 of induction o Toxicity: Incidence of severe toxicities (Grade ≥ 3) directly asparaginaserelated (CNS thrombosis, pancreatitis, anaphylaxia, and hyperbilirubinemia) between D12 and D49 of treatment and anyway before D8 of consolidation
次要结局
- - to evaluate the incidence of rare subgroups of ALL and their prognostic value e.g. so-called “B-other” subgroup: BCR-ABL like (including EBF1-PDGFRB), MEF2D-X, ZNF384-X, TCF3-HLF… - 5 year EFS, DFS and OS of the rare patients with suboptimal response to therapy (induction failure or MRDTP1 ≥ 10-3) and ABL-class fusions ALLs treated with imatinib - Imatinib related adverse events in the rare patients with suboptimal response to therapy (induction failure
研究者
Pr BARUCHEL Andre
Scientific
Assistance Publique Hopitaux De Paris
研究点 (1)
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