研究项目库 / NCT07440290

Dabrafenib用于血液系统恶性肿瘤的II 期 / III 期研究

这是一项关于血液系统恶性肿瘤的II 期 / III 期研究,登记的药物或干预包括Dabrafenib;Trametinib,当前状态为招募中。登记地点显示中国Belfast、Birmingham、Bristol、Cambridge等城市有研究中心记录。是否仍有名额以及是否值得进一步询问,需要向研究中心确认。

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这是一项关于血液系统恶性肿瘤的II 期 / III 期研究,登记的药物或干预包括Dabrafenib;Trametinib,当前状态为招募中。登记地点显示中国Belfast、Birmingham、Bristol、Cambridge等城市有研究中心记录。是否仍有名额以及是否值得进一步询问,需要向研究中心确认。

药物或干预

Dabrafenib;Trametinib · II 期 / III 期

登记条件中文摘要

年龄范围:1岁及以上

登记的基本范围为不限性别,年龄1岁及以上;以下仅摘录8项专业入选条件,需结合英文原文并由研究团队确认。

登记摘要未单独列出可展示的排除条件,请查看英文原文并向研究团队确认。

中国哪些地方有记录

以下地点来自登记信息,不代表此刻仍有名额;请向研究中心确认最新情况。

  • Belfast City Hospital · Belfast
  • University Hospital Birmingham · Birmingham
  • Birmingham Children's Hospital · Birmingham
  • Bristol Royal Hospital for Children · Bristol
  • Bristol Haematology and Oncology Centre · Bristol
  • Addenbrooke's Hospital · Cambridge
  • Velindre Cancer Centre · Cardiff
  • Cardiff Children's Hospital · Cardiff
  • Western General Hospital · Edinburgh
  • The Beatson Hospital · Glasgow
  • Royal Hospital for Children Glasgow · Glasgow
  • Leicester Royal Infirmary · Leicester
  • Alder Hey Hospital · Liverpool
  • University College London Hospital · London
  • Guy's Hopsital · London
  • Great Ormond Street Hospital · London
  • Royal Manchester Children's Hospital · Manchester
  • The Christie Hospital · Manchester
  • Clatterbridge Cancer Centre · Metropolitan Borough of Wirral
  • Great North Children's Hospital · Newcastle
  • Freeman Hospital · Newcastle
  • Churchill Hospital · Oxford
  • John Radcliffe Hospital · Oxford
  • Weston Park Hospital · Sheffield
  • Sheffield's Children's Hospital · Sheffield
  • Southampton General Hospital · Southampton
  • The Royal Marsden Hospital · Sutton

入选条件原文摘录

以下为摘录,请打开原始登记查看完整入排标准。

  • THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 07 (DABRAFENIB AND TRAMETINIB) OUTLINED BELOW\* \*When dabrafenib- and trametinib-specific inclusion/exclusion criteria or precautions below differ from those specified in the Master Protocol, the dabrafenib- and trametinib-specific criteria will take precedence.
  • Inclusion criteria:
  • A. Confirmed diagnosis of a malignancy harbouring an oncogenic alteration in BRAF V600, including Langerhans cell histiocytosis, using an analytically validated next-generation sequencing method.
  • B. Patients ≥1 year old and ≥8 kg in body weight.
  • C. Women of childbearing potential are eligible provided that they meet the following criteria:
  • • Have a negative serum or urine pregnancy test before enrolment and;
  • • Agree to use one form of a non-hormonal highly effective contraception method (a method that can achieve a failure rate of \<1% when used consistently and correctly; the requirement for non-hormonal method is because dabrafenib may decrease the efficacy of oral or any systemic hormonal contraceptives), such as: i. intrauterine device (IUD), ii. bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking trial treatment), iii. vasectomised partner, iv. total sexual abstinence. Effective from the first administration of dabrafenib and trametinib (whichever is first), throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).
  • Patients who are breastfeeding must be willing to discontinue breastfeeding from the start of treatment, throughout the trial and for two weeks following discontinuation of dabrafenib and for 16 weeks following discontinuation of trametinib (whichever is later).

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查看登记信息

登记号:NCT07440290;登记信息更新于 2026-08-17;本站同步于 2026-10-08。

查看原始登记记录