NCT01516567已完成2 期
Intergroup Trial for Children or Adolescents With B-Cell NHL or B-AL: Evaluation of Rituximab Efficacy and Safety in High Risk Patients - Phase II Trial of DA-EPOCH-Rituximab in PMLBL
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 9
- 主要终点
- Event free survival
研究概览
简要总结
Phase II trial to determine the efficacy of Dose Adjusted-EPOCH-Rituximab regimen in children and adolescent with primary mediastinal large B cell lymphoma in terms of event free survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven Primary Mediastinal Large B-Cell Lymphoma (PMLBL).
- •PMLBL without central nervous system (CNS) involvement.
- •6 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
- •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, mucosa-associated lymphoid tissue (MALT) and nodular marginal zone
- •PMLBL patients with CNS involvement
- •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.
- •There will be no exclusion criteria based on organ function.
- •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 hepatitis B virus (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.
研究组 & 干预措施
DA-EPOCH-R
Experimental
6 courses of Dose Adjusted-EPOCH-Rituximab
干预措施: Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab (Drug)
结局指标
主要结局
Event free survival
时间窗: 36 months
Minimum time to death from any cause, presence of viable cells in residue after 6th DA-EPOCH course, relapse, progressive disease, or second malignancy measured from registration.
次要结局
- Survival(5 years)
- Long term toxicity(5 years)
- Acute toxicity(6 months)
研究者
研究点 (9)
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