Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
Prospective Study of Rituximab Combined With Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia
研究概览
地位
条件
详细说明
Acute lymphoblastic leukemia (ALL) is a group of biologically heterogeneous diseases with diverse prognosis. Novel strategies for adult ALL have approached a CR rate of over 80%, which is similar to pediatric ALL. But the long term survival of adult ALL is only 30%-40%, much lower than pediatric patients.
In our trial, all the patients will first receive Vincristine 1.4mg/m2, max 2mg IV days 1,8,15,22, Daunorubicin 45mg/m2 IV days 1-3,Cyclophosphamide 750mg/m2 IV day 1 and prednisone 40-60mg/m2,by mouth days 1-14 (VDCP)regimen as initial induction therapy. If patients achieve complete remission after induction, they will be enrolled in our study for further consolidation and maintenance. If the tumor cells in bone marrow remain 5% to 20% after induction, the patients will receive VDCLP(VDCP+L-asparaginase 6000IU/m2 IV days5,7,9,11,13) and be enrolled until complete remission.
Rituximab is the main experimental intervention in our study.The consolidation regimen is HyperCVAD/MA or R-HyperCVAD/MA for totally 8 courses. The maintenance regimen includes 6-Mercaptopurine+Methotrexate for 24 months, Vincristine+Prednisone for the first 12 months, L-asparaginase in month 3 and 9 with or without Rituximab in month 6 and 12.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Shanghai
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Shanghai、Shanghai、中国、200025
- Ruijin Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Diagnosis of CD20-positive ALL
- Adequate liver function (bilirubin less than or equal to 1.5*ULN, unless considered due to tumor), and renal function (creatinine less than or equal to 1.5*ULN, unless considered due to tumor)
- Signed informed consent
Exclusion Criteria:
- Prior history of treatment with high-dose Ara-C, MTX or rituximab
- Pregnant or lactating women
- History of allergy to rituximab
- Unable to sign informed consent
- Active replication of HBV
- History of stem cell transplantation
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：HyperCVAD
Consolidation: HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. |
在最后一剂环磷酰胺给药后第 4 天通过 CVC 在 2-24 小时内静脉注射 50 mg/m2（奇数疗程）。
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses).
Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses).
Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month.
40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses)
2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).
Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses).
Maintenance:25mg/m2 weekly for 24 months.
Maintenance:60mg/m2 daily for 24 months.
Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month.
Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month.
|
|
实验性的：R-HyperCVAD
Consolidation: R-HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. Rituximab in month 6 and 12. |
在最后一剂环磷酰胺给药后第 4 天通过 CVC 在 2-24 小时内静脉注射 50 mg/m2（奇数疗程）。
300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses).
Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses).
Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month.
40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses)
2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).
Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses).
Maintenance:25mg/m2 weekly for 24 months.
Maintenance:60mg/m2 daily for 24 months.
Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month.
Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month.
Consolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times). Maintenance:375 mg/m2 IV in 6th month and 12th month. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
CR duration
大体时间：After two 21-day courses
|
Bone marrow MRD examination every two months
|
After two 21-day courses
|
|
disease free survival
大体时间：2 year
|
2 year
|
合作者和调查者
调查人员
- 首席研究员：Weili Zhao, MD,PhD、Department of hematology Ruijin Hospital/Shanghai Institute of Hematology
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 免疫系统疾病
- 组织学类型的肿瘤
- 肿瘤
- 淋巴增生性疾病
- 淋巴系统疾病
- 免疫增生性疾病
- 白血病
- 前体细胞淋巴细胞白血病-淋巴瘤
- 白血病、淋巴细胞
- 药物的生理作用
- 药理作用的分子机制
- 抗感染药
- 自主代理
- 周围神经系统药物
- 抗病毒药物
- 核酸合成抑制剂
- 酶抑制剂
- 抗炎药
- 抗风湿药
- 抗代谢药、抗肿瘤药
- 抗代谢物
- 抗肿瘤药
- 免疫抑制剂
- 免疫因素
- 微管蛋白调节剂
- 抗有丝分裂剂
- 有丝分裂调节剂
- 止吐药
- 胃肠道药物
- 糖皮质激素
- 荷尔蒙
- 激素、激素替代品和激素拮抗剂
- 抗肿瘤药，激素
- 抗肿瘤药，烷基化
- 烷化剂
- 清髓性激动剂
- 抗肿瘤药，植物性
- 拓扑异构酶 II 抑制剂
- 拓扑异构酶抑制剂
- 抗肿瘤药，免疫学
- 皮肤病药物
- 抗生素、抗肿瘤药
- 生殖控制剂
- 堕胎药，非甾体
- 堕胎剂
- 叶酸拮抗剂
- 地塞米松
- 环磷酰胺
- 利妥昔单抗
- 强的松
- 阿霉素
- 阿糖胞苷
- 甲氨蝶呤
- 长春新碱
- 门冬酰胺酶
- 巯嘌呤
其他研究编号
- RJ-2010-56
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