EUCTR2008-003235-20-SE进行中（未招募）不适用
OPHO-ALL-2008Treatment Protocol for Children (1.0 - 17.9 years of age) with Acute Lymphoblastic Leukemia - NOPHO-ALL-2008-1a
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- •1.Non-B ALL.
- •2.Non-Ph+ ALL.
- •3.Age 1.0-17.9 years.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •1.Bilineage ALL.
- •2.Pre-treatment with glucocorticosteroids or other antileukemic agents. Patients, who have been treated with systemic glucocorticosteroids or other anticancer agents (e.g. methotrexate or thiopurines) for more than a week prior to the diagnosis of ALL and initiation of antileukemic therapy, can be treated by the NOPHO ALL-2008 protocol and will be registered, but they cannot be included in the randomised trials.
- •3.Incomplete exploration for the risk group stratifying cytogenetic aberrations.
- •4.ALL predisposition syndromes. Patients with certain ALL-predisposing disorders (e.g. Down syndrome, Ataxia Telangiectasia) can be entered into the protocol with the amendments outlined in section 16, but can not be included in the randomised trials.
- •5.Previous cancer. Patients who have previously been treated for a malignant neoplasm can be treated by the NOPHO ALL-2008 protocol and will be registered, but they cannot be included in the randomised trials (see section 16). They will be treated according to the control arms of the protocol.
- •6.Intolerance to one or more anticancer agent.
- •7.Administration of additional chemotherapy during induction therapy for non-HR ALL. Patients with non-HR ALL, who at day 15 have a M3 bone marrow should not be given additional chemotherapy. If given, the patients will not be eligible for the SR-ALL treatment arm and the patient will not be eligible for randomisation.
- •8.Sexually active females not using contraception.
- •9. TPMT-deficiency (6MP-randomisation only).
- •10. DepoCyte during induction therapy (DepoCyte randomisation only)
研究者
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