招募中 NCT04043494

儿童及青少年淋巴母细胞淋巴瘤国际合作治疗方案

淋巴瘤Phase III

主要目标: * 随机化 R1,所有符合条件的患者:探讨包含 dexamethasone(实验组)而非 prednisone(标准组)的改良诱导治疗能否降低涉及中枢神经系统的复发累积发生率(中枢神经系统复发,pCICR) * 随机化 R2,仅限高危 LBL 患者:探讨这些患者的无事件生存期概率(pEFS)能否改善

适应症:Lymphoblastic Lymphoma, Childhood

入组条件

纳入标准

  • newly diagnosed lymphoblastic lymphoma
  • age \<18 years
  • patient enrolled in a participating center
  • written informed consent of patient (\>14 years of age or according to local law and regulation) and parents to trial participation and transfer and processing of data
  • willingness of patients and the investigator/pathologist to provide adequate slides/blocks for reference (molecular) pathology and international pathology panel and/or fresh or fresh frozen samples for genetic risk group stratification if these samples are available after standard diagnostic procedures.

排除标准

  • lymphoblastic lymphoma as secondary malignancy
  • non-lymphoma related relevant medical, psychiatric or social conditions incompatible with trial treatment, including among others
  • prior organ transplant
  • severe immunodeficiency
  • demyelinating Charcot-Marie Tooth syndrome
  • serious acute or chronic infections, such as HIV, VZV and tuberculosis
  • urinary tract infection, cystitis, urinary outflow obstruction, severe renal impairment (creatinine clearance less than 20 ml/min)
  • severe hepatic impairment (bilirubin \>3 times ULN, transaminases \>10 times ULN)
  • myocardial insufficiency, severe arrhythmias
  • ulcers of the oral cavity and known active gastrointestinal ulcer disease
  • known hypersensitivity to any IMP and to any excipient (listed in section 6.1 of the respective SmPC)
  • steroid pre-treatment with ≥ 1 mg/kg/d for more than two weeks during the last month before diagnosis
  • vaccination with live vaccines within 2 weeks before start of protocol treatment
  • treatment started according to another protocol or pre-treatment with cytostatic drugs
  • participation in another clinical trial that interferes with the protocol, except NHL-BFM Registry 2012 and trials with different endpoints, involving aspects of supportive treatment, which can run parallel to LBL 2018 without influencing the outcome of this trial (e.g. trials on antiemetics, antibiotics, strategies for psychosocial support)
  • evidence of pregnancy or lactation period
  • sexually active adolescents not willing to use highly effective contraceptive method (pearl index \< 1) until 12 months after end of cytostatic therapy

入组条件维持 ClinicalTrials.gov 原始英文登记资料,实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源:ClinicalTrials.gov,每两周自动更新,最后同步:2026年10月8日。