Treatment Regimen or Children or Adolescent With Mature B-cell NHL or B-AL in China
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 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 adding 4 injections of rituximab and increasing the intensity of chemotherapy regimens in advanced patients can improve the EFS compared with the historical study CCCG-NHL-2010.
详细描述
In our previous study (CCCG-NHL-2010), two-year EFS was 100% for Stage I, 91.3% ± 6.1% for Stage II, 75.8% ± 4.4% for Stage III, 56.3% ± 13.5% for Stage IV, and 36.4% ± 14.5% for B-AL, respectively. To improve survival for pediatric patients with B-NHL/B-AL, the investigators launched a new study in China. Compared with our previous treatment regimens (CCCG-2010), patients with stage III and LDH>4 times NL, any stage IV or B-AL were stratified into R4. The dose of methotrexate was increased to 5000mg/m2 for patients in R3 or R4 (previously 3000mg/m2). Four injections of rituximab was added to the chemotherapy for patients in R4. Our aim is to test whether adding rituximab or high dose of methotrexate (5000mg/m2) would improving 2-year EFS for patients in advanced groups.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology or cytologically confirmed matureB-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 CD
- •Prior exposure to rituximab.
- •Hepatitis B carrier status history of HBV or positive serology.
研究组 & 干预措施
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 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: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone (Drug)
Risk group2
Not or incompletely resected stage I/II disease and LDH <2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
干预措施: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group2
Not or incompletely resected stage I/II disease and LDH <2 times NL: 5 courses (A--B--A--B--A) and 8 intrathecal injections;
干预措施: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone (Drug)
Risk group3
Stage III with high LDH < 4 times NL, or Stage I,II with LDH >=2 times NL: Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-A-BB-AA-BB-AA-BB) and 13 intrathecal injections; Dosage of Cytarabine, Methotrexate and Etoposide was increased in AA or BB compared with A or B. Vindelsine was used in AA/BB instead of Vincristine in A/B.
干预措施: Prednisone,Vincristine, Cyclophosphamide (Drug)
Risk group3
Stage III with high LDH < 4 times NL, or Stage I,II with LDH >=2 times NL: Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-A-BB-AA-BB-AA-BB) and 13 intrathecal injections; Dosage of Cytarabine, Methotrexate and Etoposide was increased in AA or BB compared with A or B. Vindelsine was used in AA/BB instead of Vincristine in A/B.
干预措施: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group3
Stage III with high LDH < 4 times NL, or Stage I,II with LDH >=2 times NL: Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-A-BB-AA-BB-AA-BB) and 13 intrathecal injections; Dosage of Cytarabine, Methotrexate and Etoposide was increased in AA or BB compared with A or B. Vindelsine was used in AA/BB instead of Vincristine in A/B.
干预措施: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group3
Stage III with high LDH < 4 times NL, or Stage I,II with LDH >=2 times NL: Preface followed by 6 courses (P(Cyclophosphamide/Vincristine/Prednisone)-A-BB-AA-BB-AA-BB) and 13 intrathecal injections; Dosage of Cytarabine, Methotrexate and Etoposide was increased in AA or BB compared with A or B. Vindelsine was used in AA/BB instead of Vincristine in A/B.
干预措施: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone (Drug)
Risk group4
Stage III with LDH≥4N, or Stage IV, or B-AL: Preface followed by 4 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections: P-A-(Rituximab)BB-(Rituximab)AA-(Rituximab)BB-(Rituximab)AA-BB; rituximab is at D0 of each course.
干预措施: Prednisone,Vincristine, Cyclophosphamide (Drug)
Risk group4
Stage III with LDH≥4N, or Stage IV, or B-AL: Preface followed by 4 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections: P-A-(Rituximab)BB-(Rituximab)AA-(Rituximab)BB-(Rituximab)AA-BB; rituximab is at D0 of each course.
干预措施: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group4
Stage III with LDH≥4N, or Stage IV, or B-AL: Preface followed by 4 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections: P-A-(Rituximab)BB-(Rituximab)AA-(Rituximab)BB-(Rituximab)AA-BB; rituximab is at D0 of each course.
干预措施: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone (Drug)
Risk group4
Stage III with LDH≥4N, or Stage IV, or B-AL: Preface followed by 4 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections: P-A-(Rituximab)BB-(Rituximab)AA-(Rituximab)BB-(Rituximab)AA-BB; rituximab is at D0 of each course.
干预措施: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone (Drug)
Risk group4
Stage III with LDH≥4N, or Stage IV, or B-AL: Preface followed by 4 dose of rituximab (375mg/m2) combined 6 courses of chemotherapy, together with 13 intrathecal injections: P-A-(Rituximab)BB-(Rituximab)AA-(Rituximab)BB-(Rituximab)AA-BB; rituximab is at D0 of each course.
干预措施: Rituximab (Drug)
结局指标
主要结局
Event free survival
时间窗: 2 year
次要结局
- Overall survival(5 year)
研究者
Yi-Jin Gao
Shanghai Children's Medical Center, School of Medicine, Shanghai Jiaotong University, Shanghai, China
Children's Cancer Group, China