癌研連線CancerLink
已完成 NCT01516580

针对儿童或青少年B细胞非何杰金氏淋巴瘤或B型急性白血病之组间随机试验：于高风险患者中评估rituximab

淋巴瘤白血病Phase IIIIII 期IV 期

本试验旨在测试在标准「Lymphome malin B」LMB化疗方案中加入6次rituximab注射，相较於单用LMB化疗，能否改善晚期B细胞非何杰金氏淋巴瘤（NHL）／B型急性白血病（B-AL）（第III期且LDH > Nx2、任何第IV期或B-AL）儿童／青少年的无事件生存期（EFS）。

适应症：B-cell Non Hodgkin Lymphoma、Mature B-cell Leukemia Burkitt-type

入组条件

纳入标准

  • Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.
  • Stage III with elevated LDH level ("B-high"), \[LDH \> twice the institutional upper limit of the adult normal values (\> Nx2)\] or any stage IV or B-AL.
  • months to less than 18 years of age at the time of consent.
  • Males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab and during five months for men, taking into account the characteristics of methotrexate.
  • Complete initial work-up within 8 days prior to treatment that allows definite staging.
  • Able to comply with scheduled follow-up and with management of toxicity.
  • Signed informed consent from patients and/or their parents or legal guardians

排除标准

  • Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study
  • Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.
  • Evidence of pregnancy or lactation period.
  • Past or current anti-cancer treatment except corticosteroids during less than one week.
  • Tumor cell negative for CD20
  • Prior exposure to rituximab.
  • Severe active viral infection, especially hepatitis B.
  • Hepatitis B carrier status history of HBV or positive serology.
  • Participation in another investigational drug clinical trial.
  • Patients who, for any reason, are not able to comply with the national legislation.

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。