NCT02617004招募中不适用
Multicenter Trial Treatment of Philadelphia Chromosome Negative (Ph-) B-lineage Acute Lymphoblastic Leukemia (ALL) of Young Adults (18-59 Years).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
The purpose of this study is to prospectively validate the new risk model, based on minimal residual disease (MRD) response level and oncogenetic status by comparing historical results of GRAALL-2005 with those of GRAALL-2014 in an identical population of patients (Philadelphia chromosome negative, B lineage ALL, aged 18 to 59 years old).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Whose blood and bone marrow explorations have been completed before the steroids prephase
- •Aged 18 to 59 years old with not previously treated (including intrathecal injection) B-lineage-ALL newly diagnosed according to the WHO 2008 definition with ≥ 20% bone marrow blasts
- •Whose karyotype shows no t(9;22) and/or the absence in molecular biology of breakpoint cluster region-Abelson (BCR-ABL)
- •With Eastern Cooperative Oncology Group (ECOG) performance status ≤3
- •With or without central nervous system (CNS) or testis involvement
- •Without other evolving cancer (except basal cell carcinoma of the skin or "in situ" carcinoma of the cervix) or its radiotherapy or chemotherapy treatment should be finished at least since 6 months
- •Having signed a written informed consent
- •With efficient contraception for women of childbearing age (excluding estrogens and IUD)
- •With health insurance coverage
- •Who have received or being receiving the steroid prephase
排除标准
- •With lymphoblastic lymphoma and bone marrow blasts < 20%, Burkitt-type ALL, or with antecedents of chronic myeloid leukemia (CML) or other myeloproliferative neoplasm
- •With contra-indication to anthracyclines or any other general or visceral contra-indication to intensive therapy except if considered related to the ALL:
- •Aspartate transaminase (AST) and/or alanine transaminase (ALT) > 5 x upper limit of normal range (ULN)
- •Total bilirubin ≥ 2.5 x upper limit of normal range (ULN)
- •Creatinine >1.5x upper limit of normal range (ULN) or creatinine clearance <50 mL/mn
- •Myocardial infarction within 6 months prior to inclusion in the trial, cardiomyopathy (NYHA grade III or IV), left ventricle ejection fraction (LVEF) < 50% and or Shortening fraction < 30%,
- •Active severe infection or known seropositivity for HIV or human T cell leukemia/lymphoma virus type 1 (HTLV1) or active hepatitis B or C
- •Pregnant (beta-Human Chorionic Gonadotropin positive) or nursing woman
- •Not able to bear with the procedures or the frequency of visits planned in the trial
- •Unable to consent, under tutelage or curators, or judiciary safeguard.
结局指标
主要结局
Disease free survival (DFS)
时间窗: 4 years
次要结局
- non relapse mortality (NMR)(4 years)
- Cumulative incidence of relapse (CIR)(4 years)
- Overall survival(4 years)
- overall survival after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)(4 years)
- Disease free survival (DFS) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)(4 years)
- Minimal residual disease (MRD)(1 year)
- Cumulative incidence of relapse (CIR) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)(4 years)
- Non relapse mortality (NRM) after censoring at allo-stem cell transplantation (SCT) in first complete remission (CR)(4 years)
研究者
研究点 (1)
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