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临床试验 NCT06607419 (BBClean) 针对B-Cell Lymphoblastic Leukemia目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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上海交通大学Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia (BBClean) II期, III期 90 儿科
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临床试验NCT06607419 (BBClean)旨在研究治疗，主要针对B-Cell Lymphoblastic Leukemia。这是一项II期 III期 干预性研究试验，目前试验状态为招募中。试验始于2024年5月21日，计划招募90名患者。该研究由上海交通大学主导，预计于2030年5月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年9月23日。
简要概括
The goal of this clinical trial is to evaluate the efficacy of Blinatumomab in pediatric patient with newly diagnosed acute B-Lymphoblastic leukemia with poor response to early chemotherapy, i.e. day 19 MRD ≥ 0.1% (low-risk) or day 19 MRD ≥ 0.01% (intermediate-risk). The main question is:
• If the flow cytometric MRD negative (<0.01%) rate and the NGS- MRD negative (<0.0001%) rate at the end of induction for patie...
显示更多官方标题
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
疾病
B-Cell Lymphoblastic Leukemia出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- BBClean
- CBC-ALL2024-1
NCT编号
实际开始日期
2024-05-21
最近更新发布
2024-09-23
预计完成日期
2030-05-31
计划入组人数
90
研究类型
干预性研究
试验分期 (阶段)
II期
III期
III期
试验状态
招募中
关键词
Children
B-Cell Lymphoblastic Leukemia
Blinatumomab
B-Cell Lymphoblastic Leukemia
Blinatumomab
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Blinatumomab Patients in this group should receive Blinatumomab | Blinatumomab Recruited patients will receive Blinatumomab since day 29 of induction for 14 days. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
The flow cytometric MRD | The flow cytometric MRD negative (\<0.01%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol) | From the date of Blinatumomab completion to one week after its treatment course |
The NGS- MRD | The NGS- MRD negative (\<0.0001%) rate at the end of induction for patients received Blinatumomab will superior to historical control (D46MRD in the CCCG-ALL2020 protocol) | From the date of Blinatumomab completion to one week after its treatment course |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
5-year EFS | The 5-year EFS of study group was significantly higher than that of the control group. | 5 years since the last recruited patient completed Blinatumomab. |
Adverse events | Comparison of adverse events in study and control groups | From day 19 of induction therapy until the start of the second high-dose methotrexate regimen. |
Healthcare costs | Comparison of healthcare costs in study and control groups | Six-month since window phase |
参与助手
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
1 Month
适龄性别
全部
- Age older than 1 month to younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Immunophenotyping: acute B-lymphoblastic leukemia;
- Meet one of the following situations:
A. Provisional low-risk: D19MRD ≥ 0.1%; B. Provisional intermediate-risk: D19MRD ≥ 0.01%;
- Subjects in the sytudy group or their guardians must be able to understand and accept the informed consent approved by the Ethics Committee
- sIgM+;
- ALL evolved from chronic myeloid leukemia (CML);
- Down's syndrome, or major congenital or hereditary disease with organ dysfunction;
- Other secondary leukemias;
- CNS involvement;
- History of epilepsy; or convulsions within the last month;
- Known underlying congenital immunodeficiency or metabolic disease;
- Congenital heart disease with cardiac insufficiency;
- Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for > 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression);
- Initial diagnosis of high risk;
- D46MRD ≥1%.
上海交通大学327 个活跃的临床试验可供探索- 🏥Fu...
研究责任方
Shuhong Shen, 主要研究者, Chair of hematology oncology department of SCMC, Shanghai Jiao Tong University School of Medicine
研究中心联系人
联系人: Shuhong Shen, PhD/MD, 86-18930830638, [email protected]
联系人: Wenting Hu, MD, 13524836748, [email protected]
4 位于 1 个国家/地区的研究中心
Anhui
Anhui Provincial Children's Hospital, Hefei, Anhui, 230051, China
Hongjun Liu, MD, 联系人, 13515657759, [email protected]
尚未招募
Fujian
Fujian Children's Hospital, Fuzhou, Fujian, 350011, China
Hui Zhang, PhD/MD, 联系人, 15821333007, [email protected]
尚未招募
Shanghai Municipality
Shanghai Children's Medical center, Shanghai, Shanghai Municipality, 200127, China
Shuhong Shen, PhD/MD, 联系人, 86-21-38626161, [email protected]
Wenting Hu, MD, 联系人, 13524836748, [email protected]
Shuhong Shen, PhD/MD, 主要研究者
Wenting Hu, MD, 分研究者
Changcheng Chen, MD, 分研究者
招募中
Zhejiang
Ningbo Women and Children's Hospital, Ningbo, Zhejiang, 315012, China
Binfei Hu, MD, 联系人, 13777028360, [email protected]
招募中