JPRN-jRCTs041210104招募中2 期
Multicenter clinical trial to evaluate the efficacy of rituximab combination chemotherapy for children or AYAswith localized mature B-cell lymphoma - JPLSG-B-NHL-20
Sekimizu Masahiro0 个研究点目标入组 100 人开始时间: 2021年11月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6month old 至 < 26age old（—）
- 性别
- All
入选标准
- •(1) Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.
- •(2) (Low risk) resected Stage I/II, (Intermediate risk) unresected Stage I/II, Stage III with elevated LDH level (LDH (3) 6 months to less than 26 years of age at the time of consent.
- •(4) Newly diagnosed and untreated except for short term steroid (=< 7days)
- •(5) Available for prescribed follow-up and control of therapeutic toxicity.
- •(6) Written informed consent obtained from the patient and/or legally acceptable representatives.
- •(7) Consent to JPLSG-CHM-14 study (3rd edition and above)
排除标准
- •(1) PMLBL, Follicular lymphoma, MALT and nodal marginal zone lymphoma
- •(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) Exclusion criteria related to rituximab
- •4-1) Tumor cell negative for CD20
- •4-2) Prior exposure to rituximab.
- •4-3) Severe active viral infection,
- •4-4) Severe uncontrolled infection
- •4-5) Hepatitis B carrier status history of HBV or positive serology.
- •5) Judged inappropriate by the doctor
研究者
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