CTRI/2025/03/082456尚未招募2/3 期
Efficacy and safety of substitution of bleomycin by low dose nivolumab in ABVD (Doxorubicin plus Bleomycin plus Vinblastine plus Dacarbazine) backbone chemotherapy in newly diagnosed advanced stage pediatric Hodgkin Lymphoma: A phase II/III, multicentric, open label, randomized controlled trial.
Dr Debasish Sahoo7 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2025年4月15日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 169
- 试验地点
- 7
- 主要终点
- Complete metabolic remission (CMR) rates
研究概览
简要总结
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged less than 18 years with newly diagnosed classical Hodgkin lymphoma
- •Stage II B- IV disease
- •No prior treatment for disease (except steroids up to 7 days for superior mediastinal syndrome)
- •Informed consent given.
- •Patients in the reproductive age group and child bearing potential should agree for contraception or abstinence
- •Lansky performance score more than 20.
排除标准
- •Cardiac dysfunction
- •Retroviral infection
- •Active Hepatitis B or C infection
- •Jaundice, with bilirubin more than 2 mg/dL or AST and ALT more than 5 times of upper limit of normal
- •Creatinine clearance less than 70 mL/ min/ 1.73 m2 (Calculated using Schwartz formula)
- •Past history of uveitis
- •Prior history or suspicion of autoimmune disorders
- •Underlying immunodeficiency disorders.
结局指标
主要结局
Complete metabolic remission (CMR) rates
时间窗: 4 months (4 cycles of chemotherapy)
次要结局
- 2 year overall survival(2 years)
- 2 year event free survival(2 years)
- Safety of low dose nivolumab- AVD(6 months)
- Pharmacodynamics studies (Residual PD-1 expression, IL-2, IL-6, IFN, TNF)(1 month, 6 months)
研究者
Dr Debasish Sahoo
AIIMS, Bhubaneswar
研究点 (7)
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