Young Adult With Acute Lymphoblastic Leukemia (ALL) : a Multicentric Protocol. GRAALL 2005 : T ALL or B ALL Non Ph GRAALL 2005 R : B ALL Non Ph CD20+ GRAAPH 2005 : ALL Ph
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,080
- 试验地点
- 1
- 主要终点
- GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)
研究概览
简要总结
This study is a multicenter trial of treatment for young ALL patients. All ALL patients will receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then, patients will be included into 3 specific trials according to biological features (immunophenotype, cytogenetics, and molecular biology).
Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005:
- T ALL or B ALL non Ph (N=810 patients planned).
- GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned).
- GRAAPH 2005: ALL Ph+ (N=270 patients planned)
详细描述
GRAALL 2005: T ALL or B ALL non Ph
Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification.
(N=810 patients planned)
GRAALL 2005 R: B ALL non Ph CD20+
Randomization between standard versus intensified cyclophosphamide administration during a 4-drug, 4 week chemotherapy and late intensification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-59 years
- •ALL newly diagnosed (blast < 20%)
- •Central Nervous System (CNS) positive or negative
- •Signed written informed consent
- •For GRAAPH trial only: t(9;22) or BCR- ABL positive
排除标准
- •Lymphoblastic lymphoma
- •Chronic myeloid leukemia
- •Severe organ condition
结局指标
主要结局
GRAAPH: Percentage of patients with minimum residual disease (MRD) < 10-4 after induction and/or consolidation (= salvage)
时间窗: January 2014
Event free survival for all patients
时间窗: January 2014
次要结局
- CR in 1 or 2 courses(January 2014)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(January 2014)
- Relapse(January 2014)
- Death in induction(January 2014)
- Death in first CR(January 2014)
- Relapse free survival(January 2014)
- Overall Survival(January 2014)