JPRN-jRCTs041180089已完成2 期
Multi-center Trial for Children with B-cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients. - B-NHL-14
Mori Tetsuya0 个研究点目标入组 45 人开始时间: 2019年3月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
研究概览
简要总结
Efficacy of rituximab added standard LMB chemotherapy for high-risk children with B-cell NHL or B-AL were confirmed in Japan. Compared with results of the international trial, the lower incidence of non-hematologic adverse events of grade 4 or higher, and the higher proportion of patients still receiving intravenous immune globulin at 1 year after enrollment were observed.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 06month old 至 < 216month old（—）
- 性别
- All
入选标准
- •(1) 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.
- •(2) Stage III with elevated LDH level, (LDH > twice the institutional upper limit of the adult normal values) or any stage IV or B-AL.
- •(3) 6 months to less than 18 years of age at the time of consent.
- •(4) 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.
- •(5) Complete initial work-up within 8 days prior to treatment that allows definite staging.
- •(6) Able to comply with scheduled follow-up and with management of toxicity.
- •(7) Signed informed consent from patients and/or their parents or legal guardians.
- •(8) JPLSG-CHM-14 registration.
排除标准
- •Histology and staging disease
- •(1)Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study - In phase II study (PMLBL) patients with CNS involvement are not eligible.
- •General conditions
- •(2) Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ
- •transplantation, previous malignancy of any type, or known positive HIV serology.
- •(3) Evidence of pregnancy or lactation period.
- •(4) There will be no exclusion criteria based on organ function. Dosing guidelines for organ
- •dysfunction are provided in annexe D1.
- •Prior therapy
- •(5) Past or current anti-cancer treatment except corticosteroids of less than 7 days duration in total.
- •(6) Exclusion criteria related to rituximab
- •6-1)Tumor cell negative for CD20 (absence of result due to technical problems in the presence of other characteristics suggestive of BL/DLBCL, including genetic and phenotypic features, is not an exclusion criteria).
- •6-2) Prior exposure to rituximab.
- •6-3) Severe active viral infection, especially hepatitis B.
- •6-4) Severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of registration. Contact the national co- investigator for further advice if necessary.
- •6-5) Hepatitis B carrier status history of HBV or positive serology. A patient is considered as HBV
- •carrier or to have (had) HBV infection in case of:
- •6-5-1) Unimmunized and HBsAg and/or anti-HBs antibody and/or anti- HBc antibody positive,
- •6-5-2)Immunized and HBsAG and/or anti-HBc antibody positive.
- •(7) Participation in another investigational drug clinical trial.
- •(8) Patients who, for any reason, are not able to comply with the national legislation.
研究者
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