NCT00526175已完成4 期
LAL-BR/2001: Study Treatment to Low Risk ALL
PETHEMA Foundation27 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2001年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 27
- 主要终点
- To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival
研究概览
简要总结
The purpose of this study is increase the efficacy of consolidation (C1) after an intensification phase with high dose of methotrexate, applying analysis of minimal residual disease
详细描述
REMISION INDUCTION
Systemic chemotherapy:
Prednisolone (PDN):
- 60 mg/m2 day, i.v. or p.o., days 1 to 27
- 30 mg/m2 day, i.v. or p.o., days 28 to 35
Vincristine (VCR): 1,5 mg/m2 i.v., days 8, 15, 22 and 28. Daunorubicin (DNR): 30 mg/m2, i.v., days 8 and 15. L-asparaginase (L-ASA): 10.000 UI/m2, i.m. or i.v., days 9 to 11, 16 to 18 and 23 to 25.
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
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnoses of low risk acute lymphoblastic leukemia in children no treated previously
排除标准
- •Mature B-ALL (FABL3) or with cytogenetic ALL "Burkitt-like" alterations (t[8;14], t[2;8], t[8;22])
- •Mixed forms of ALL
- •Acute Leukemia no differentiate
- •Patients with coronary disorders, valvular or hypertensive cardiopathy
- •Patients with chronic liver disorders
- •Chronic pulmonary disorders
- •Renal insufficiency
- •Neurologic disfunctions
- •ECOG 3 and 4
- •No signed consent form
结局指标
主要结局
To evaluate the efficacy of treatment in order to response rate, relapse free survival and global survival
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (27)
Loading locations...
相似试验
已完成
2 期
Low-Intensity Preparation and Allogeneic Transplant in Patients With Cancers of the BloodMyeloma, Plasma-CellLymphoma, MalignantMyeloproliferative DisordersMyelodysplastic SyndromesWaldenstrom's MacroglobulinemiaNCT00146055University of Michigan Rogel Cancer Center60
已完成
2 期
Treatment of Adult ALL With an MRD-directed Programme.Acute Lymphoblastic LeukemiaNCT00358072Northern Italy Leukemia Group280
终止
2 期
Chemotherapy With Liposomal Cytarabine CNS Prophylaxis for Adult Acute Lymphoblastic Leukemia & Lymphoblastic LymphomaAcute Lymphocytic LeukemiaAdult Lymphoblastic LymphomaNCT02043587University of California, San Diego31
已完成
1 期
A Study of LCL161 in Combination With Weekly Paclitaxel in Adult Patients With Advanced Solid TumorsSolid TumorsNCT01240655Novartis Pharmaceuticals76
已完成
1 期
A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast CancerHormone Receptor Positive, HER2-negative, Advanced Breast CancerNCT02333370Novartis Pharmaceuticals88