跳至主要内容
临床试验/EUCTR2009-016075-30-IT
EUCTR2009-016075-30-IT进行中(未招募)1 期

Therapy of the Young Adult Acute Lymphoblastic Leukemia (ALL): treatment intensification of the pediatric protocol AIEOP LLA-2000 - GIMEMA LAL 1308

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO0 个研究点目标入组 30 人开始时间: 2010年7月20日最近更新:
适应症
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
30

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

  • ALL not-B mature, not Ph+ patients, phenotype line T (LLA-T) or B (LLA-B), aged =18 and <35 years (until 34 years and 364 days) and who have signed an informed consent in compliance with ICH-GCP and the applicable national laws.
  • 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
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Age < 18 and =35 years - Patients who have performed a steroid pretreatment before being registered in the study - Patients who performed an antiblastic chemotherapic pretreatment - Patients with ALL-B mature (FAB L3, sIg+, TdT-) - Patinets with Biphenotypic Acute Leukemia (EGIL criteria) - Patients with t(9;22) ALL - Patients with a punctio sicca and peripherical blasts absence - Patients with Acute undifferentiated Leukemia - Patients with serum creatinine > 2.5 mg / dl after adequate hydration - Patients with transaminases > 3 times the maximum normal value - Patients with left ventricular ejection fraction (FEV) <50% - Patients with a severe mental illness - Presence of concomitant malignant diseases - Presence of documented infections not responding to antibiotic and / or antifungal therapy - Pregnant women or lactating - Down Syndrome.

研究者

发起方
G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL`ADULTO

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