Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Event free survival
研究概览
简要总结
The purpose of this study is to test whether intensive chemotherapy combined with early, adequate, and intensive use of Rituximab for aggressive B-NHL in children and adolescents can improve the EFS and OS compared with the historical study CCCG-BNHL-2015.
详细描述
In our previous study (CCCG-BNHL-2015), four-year EFS was 88.3%, mostly owing to the use of Rituximab. However, four-year EFS was only 73% for group R4. And three-year EFS was even lower, 61% for stage IV and B-AL with LDH≥4ULN. To improve survival for pediatric patients with high risk B-NHL, the investigators launched a new study in China. In this study (CCCG-BNHL-2025), patients with stage III and LDH≥2ULN, any stage IV, and B-AL will be stratified into group R4. Six injections of Rituximab will be used for patients in R4, compared with four injections in CCCG-BNHL-2015. And two injections of Rituximab will be used in the first and second cycles of chemotherapies. The first cycle of chemotherapy will be changed into AA, instead of A. For patients with stage IV (including B-AL) with LDH≥ 4ULN, two cycles of chemotherapies(AA and BB) will be added. Our aim is to test whether intensive chemotherapies with early, adequate, and intensive use of Rituximab will improve the EFS and OS of children and adolescents with highly aggressive B-NHL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology or cytologically confirmed mature B-cell NHL/AL(Burkitt, DLBCL, PMLBL,or aggressive mature B-cell NHL non other specified or specifiable)
- •Able to comply with scheduled follow-up and with management of toxicity
- •Signed informed consent
排除标准
- •Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study
- •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. Past or current anti-cancer treatment except corticosteroids during less than one week.
- •Exclusion Criteria related to Rituximab :
- •Tumor cell negative for CD20
- •Prior exposure to rituximab
- •Hepatitis B carrier status history of HBV or positive serology.
研究组 & 干预措施
Risk group 4
Stage III with LDH≥2ULN, or Stage IV, or B-AL: Preface followed by 6 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections((16 intrathecal injections with CNS2-3): P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB; stage IV or B-AL with LDH≥5ULN:P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB-AA-BB, together with 17 intrathecal injections((21 intrathecal injections with CNS2-3)
干预措施: Prednisone,Vincristine, Cyclophosphamide (Drug)
Risk group 4
Stage III with LDH≥2ULN, or Stage IV, or B-AL: Preface followed by 6 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections((16 intrathecal injections with CNS2-3): P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB; stage IV or B-AL with LDH≥5ULN:P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB-AA-BB, together with 17 intrathecal injections((21 intrathecal injections with CNS2-3)
干预措施: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone (Drug)
Risk group 1
Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine/Methotrexate/Dexamethasone, age adjusted);
干预措施: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group 2
Not or incompletely resected stage I/II disease and LDH <2ULN: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
干预措施: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group 2
Not or incompletely resected stage I/II disease and LDH <2ULN: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
干预措施: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone (Drug)
Risk group 3
Stage III with LDH < 2 ULN, or Stage I,II with LDH in 2 to 4 ULN : Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-AA-BB-AA-BB-AA-BB) and 13 intrathecal injections(16 intrathecal injections with CNS2-3)
干预措施: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group 3
Stage III with LDH < 2 ULN, or Stage I,II with LDH in 2 to 4 ULN : Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-AA-BB-AA-BB-AA-BB) and 13 intrathecal injections(16 intrathecal injections with CNS2-3)
干预措施: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone (Drug)
Risk group 4
Stage III with LDH≥2ULN, or Stage IV, or B-AL: Preface followed by 6 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections((16 intrathecal injections with CNS2-3): P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB; stage IV or B-AL with LDH≥5ULN:P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB-AA-BB, together with 17 intrathecal injections((21 intrathecal injections with CNS2-3)
干预措施: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group 3
Stage III with LDH < 2 ULN, or Stage I,II with LDH in 2 to 4 ULN : Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-AA-BB-AA-BB-AA-BB) and 13 intrathecal injections(16 intrathecal injections with CNS2-3)
干预措施: Prednisone,Vincristine, Cyclophosphamide (Drug)
结局指标
主要结局
Event free survival
时间窗: 3 years
次要结局
- Overall survival(3 years)