EUCTR2014-002248-42-FI进行中（未招募）1 期
The TEAM Study (Thiopurine Enhanced ALL Maintenance therapy)A Phase 1-2 Study of 6-Thioguanine in Combination with Methotrexate and 6-Mercaptopurine During Maintenance 2 Therapy of Childhood, adolescent, and adult Acute Lymphoblastic Leukemia - 6TG Maintenance 2 Therapy Study
Bonkolab, Rigshospitalet0 个研究点目标入组 34 人开始时间: 2017年2月2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
- 34
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
- •Male and female patients of all ethnicities meeting all the following criteria will be considered eligible for study participation:
- •1.Confirmed diagnosis with SR/IR-ALL, treated in accordance with NOPHO ALL 2008 protocol.
- •2.Patients aged 1-45 years at the time of diagnosis.
- •3.Bilirubin < UNL according to age, factor 2-7-10 > 0.5 or INR < 1.5 within 1 week prior to inclusion.
- •4.WBC > 1.5 x109/L, ANC > 0.5 x109/L and TBC > 50 x109/L within 1 week prior to inclusion.
- •5.Subject, if female of childbearing potential (defined as post menarche), must present with a negative pregnancy test and must be non-lactating.
- •6.Sexually active females and males must use accepted safe contraception (OCPs, IUD, transdermal hormonal patch, vaginal hormonal ring or subdermal hormonal implants for women and condom for men) during therapy and until three months after study exit/early termination.
- •7.No live vaccines given within 3 months prior to inclusion.
- •8.Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- •9.Whenever appropriate, the child should participate in the oral and written informed consent process together with the parents. Involving the child in discussions and the decision-making process respects their emerging maturity. This process will be conducted with enough time and at the same time as obtaining the consent from the parents or the legal representative, so that the informed consent reflects the presumed will of the minor, in accordance with Article 4(a) of the Clinical Trial Directive.
- •10.If the study participant is unable to provide legally binding consent subject's legally authorized representative (e.i. both parent, legal guardian) must voluntarily sign and date a parental permission/ Informed Consent that is approved by the Danish Ethical Committee(EC). The subject must sign an EC approved assent, before undergoing any protocol specific procedures or assessments according to Ethical considerations for clinical trials on medicinal products conducted with the paediatric population Directive 2001/20/EC1, ICH/GCP guidelines, and the Helsinki II Declaration.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with negative minimal residual disease at treatment day 29 (counted from diagnosis), since these patients have an excellent prognosis on current therapy).
- •2.Any clinical suspicion of relapse or disease progression on routine imaging or in laboratory results.
- •3.Previous sinusoidal obstruction syndrome (SOS) / veno-occlusive disease (VOD)
- •4. Allergic hypersensitivity towards any ingredients in the three medicinal products used in the study.
研究者
相似试验
进行中（未招募）
1 期
A feasibility Study of 6-Thioguanine in Combination with Methotrexate and 6-Mercaptopurine During Maintenance Therapy of Childhood, Adolescent, and Adult Lymphoblastic Non-Hodgkin’s Lymphoma and Acute Lymphoblastic Leukemia.EUCTR2014-002248-42-DKBonkolab, Rigshospitalet60
招募中
不适用
Study on the safety of thiopurine preparations during pregnancyAll diseases for which thiopurine preparations are usedJPRN-UMIN000045148Tohoku University Hospital400
已完成
不适用
Thiopurines with Low Dose Allopurinol: a prospective one way cross-over studyCrohninflammatory bowel disease10017969NL-OMON42907Meander Medisch Centrum22
进行中（未招募）
1 期
Thiopurines with Low Dose Allopurinol: a prospective one way cross-over studyEUCTR2016-001638-84-NLMeander Medical Center
已完成
3 期
Effect on Exercise Endurance and Lung Hyperinflation of Tiotropium + Olodaterol in COPD PatientsPulmonary Disease, Chronic ObstructiveNCT01533922Boehringer Ingelheim295