EUCTR2010-020924-22-IE进行中（未招募）1 期
nited Kingdom National Randomised Trial for Children and Young Adults with Acute Lymphoblastic Leukaemia and Lymphoma 2011 - UKALL 2011
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,640
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
- •The trial is open to all patients from age 1 (first birthday) to age 24 years 364 days (at time of diagnosis) with a first diagnosis of acute lymphoblastic leukaemia or lymphoblastic lymphoma (T-NHL or SmIg negative precursor B-NHL) diagnosed using standard criteria. Written informed consent is required for all patients and a negative pregnancy test for female patients of childbearing potential within 2 weeks prior to starting treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2529
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 111
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Trial entry and R1:
- •1)Infants less than a year old at diagnosis.
- •2)Patients with B-ALL (Burkitt-like, t(8;14), L3 morphology, SmIg positive)
- •3)Patients with Philadelphia-positive ALL (t(9;22) or BCR/ABL positive)
- •4)Patients in whom informed consent has not been obtained from parents and/or patients prior to randomisation
- •5) Patients who have received prior therapy for ALL or LBL except the following:
- •a) Patients who have received a single dose of intrathecal methotrexate at the time of diagnostic LP
- •b) Patients with ALL who due to clinical urgency have received glucocorticoid (dexamethasone or prednisolone) for no more than 7 days
- •c) Patients with NHL or lymphomatous presentation of T-ALL who due to concerns over respiratory compromise or thoracic outlet obstruction have received emergency cytoreduction with glucocorticoid (dexamethasone or prednisolone) for no more than 7 days and/or up to 300mg/m2 cyclophosphamide in the previous 7 days.
- •6) Patients who are sexually active and are unwilling to use adequate contraception during therapy and for one month after last trial treatment.
- •The following patients are excluded from the methotrexate and pulses randomisation (R2):
- •1) MRD High Risk ALL patients and LBL patients with a poor response at the end of induction (<35% reduction in tumour volume)
- •2) Any patients with significant renal impairment, pleural effusions or ascites.
- •3) Previous history of methotrexate encephalopathy.
- •4) MRD Intermediate patients with a history of pancreatitis.
- •5) Candidates for allogeneic SCT in CR1.
- •6) Down's syndrome patients
- •7) Patients who have received prior cranial irradiation
- •8) Patients with M3 marrow at day 29.
研究者
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