EUCTR2013-003466-13-DE进行中（未招募）1 期
Treatment optimization in adult patients with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma by individualised, targeted and intensified treatment - a phase IV-trial with a phase III-part to evaluate safety and efficacy of nelarabine in T-ALL patients - GMALL 08/2013
Goethe University Frankfurt0 个研究点目标入组 900 人开始时间: 2015年5月5日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Acute lymphoblastic leukemia (all subtypes except burkitt leukemia, blasts in BM = 25%
- •Lymphoblastic lymphoma (B- or T-lineage), blasts in BM <25%
- •Age: = 18 - = 55 years
- •Written Informed consent to participate in the study and the GMALL registry
- •Women of childbearing potential (WOCBP) and male sexual partners of WOCBP must be willing to use an effective method of contraception (Pearl-Index < 1%) during the study and at least 6 months thereafter
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 900
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Serious complications (leukemia associated) or concomitant diseases, such as
- •- severe uncontrollable complications (leukemia associated), i.e. sepsis, pneumonia with hypoxia, shock, bleeding at diagnosis
- •- renal insufficiency, if not caused by leukemia
- •- severe impairment of heart or liver function (if not caused by leukemic infiltration)
- •- severe obstructive or restrictive pulmonary disease
- •- known HIV infection or other uncontrolled infections
- •- any other condition that compromises the patient’s eligibility for intensive treatment as described by the study protocol
- •Late relapse of childhood leukemia or concurrent malignancy
- •Previous cytostatic treatment
- •- ALL directed (exceptions: standard prephase, application of steroids = 7 days, once-only application of vincristine, cyclophosphamide or other substances as emergency medical intervention)
- •- directed to other malignancies within the last 10 years before diagnosis of ALL
- •Pregnancy or breastfeeding
- •Severe psychiatric disease or any severe concomitant condition under which the patient's understanding of importance and consequences of study participation and/or compliance and therapy according to study protocol cannot be expected
- •At diagnosis: participation in another trial that interferes with the antileukemic treatment
- •(exceptions: trials aiming at supportive care, defined accompanying GMALL trials, and at a later timepoint trials with experimental substances, i. e. in case of molecular treatment failure)
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