A Pilot Study of Risk Adapted Therapy Utilizing Upfront Brentuximab With Combination Chemotherapy in the Treatment of Children, Adolescents and Young Adults With Newly Diagnosed Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events)
研究概览
简要总结
The addition of Brentuximab vedotin (Bv) to combination chemotherapy will be safe, well tolerated and effective in children, adolescents and young adults with all stages of newly diagnosed Hodgkin lymphoma (HL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Normal Serum creatinine based on age or creatinine clearance >60 ml/min/1.73 m2 or an equivalent radioisotope glomerular filtration rate (GFR) as determined by the institutional normal range.
- •Direct bilirubin < 1.5 upper limit of normal (ULN) for age, and SGOT (AST) or SGPT (ALT) <3 x ULN
- •Shortening fraction >27% by echocardiogram, or
- •Ejection fraction of >50% by radionuclide angiogram or echocardiogram.
- •For patients age 1-16 years, Lansky score of ≥
- •For patients > 16 years, Karnofsky score of ≥
- •No prior Hodgkin lymphoma directed therapy is allowed except for emergent mediastinal irradiation (<1000cGy) for superior vena cava (SVC) syndrome.
排除标准
- •Females who are pregnant (positive HCG) or lactating.
- •Karnofsky <60% or Lansky <60% if less than 16 years of age.
- •Age ≤1 year or >29.99 years of age.
研究组 & 干预措施
Low Risk
Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
干预措施: Brentuximab Vedotin (Drug)
Low Risk
Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
干预措施: Doxorubicin (Drug)
Low Risk
Low Risk Patients (Stage IA, IIA; no bulky disease or extension): 3 cycles of chemotherapy
干预措施: Vincristine (Drug)
Intermediate Risk
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
干预措施: Brentuximab Vedotin (Drug)
Intermediate Risk
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
干预措施: Doxorubicin (Drug)
Intermediate Risk
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
干预措施: Vincristine (Drug)
Intermediate Risk
Intermediate Risk Patients (Stage IA bulk/E, IB, IIA bulk/E, IIB, IIIA): 4 cycles of chemotherapy
干预措施: Rituximab (Drug)
High Risk
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
干预措施: Brentuximab Vedotin (Drug)
High Risk
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
干预措施: Doxorubicin (Drug)
High Risk
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
干预措施: Vincristine (Drug)
High Risk
High Risk Patients (Stage IIIA bulk/ E, IIIB, IVA/B): 6 cycles of chemotherapy
干预措施: Rituximab (Drug)
结局指标
主要结局
To determine if this combination of chemoimmunotherapy is safe to administer. (Adverse events)
时间窗: 1 year
Adverse events will be monitored each cycle to determine if there are any events related possibly, probably or definitely related to study therapy
To determine the response rate
时间窗: 1 year
disease evaluations will be performed after the 2nd, 4th and 6th cycles.
次要结局
未报告次要终点
研究者
Mitchell Cairo
Executive Vice Chair
New York Medical College