B-Cell Lymphoblastic Leukemia
Conditions
Keywords
Children, B-Cell Lymphoblastic Leukemia, Blinatumomab
Brief summary
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 patients received Blinatumomab will be superior to historical control (D46MRD in the CCCG-ALL2020 protocol). Participants will: * Take 14 days full dose Blinatumomab; * With bone marrow evaluated before and after Blinatumomab treatment.
Interventions
DRUGBlinatumomab
Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.
Sponsors
Fujian Children's Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Guizhou Provincial People's Hospital
The First Affiliated Hospital of Xiamen University
Dalian Women and Children's Medical Center
The Third Xiangya Hospital of Central South University
Hunan Provincial People's Hospital
Ningbo Women & Children's Hospital
Anhui Provincial Children's Hospital
Jiangxi Province Children's Hospital
Yuying Children's Hospital of Wenzhou Medical University
Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The flow cytometric MRD | From the date of Blinatumomab completion to one week after its treatment course | 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) |
| The NGS- MRD | From the date of Blinatumomab completion to one week after its treatment course | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-year EFS | 5 years since the last recruited patient completed Blinatumomab. | The 5-year EFS of study group was significantly higher than that of the control group. |
| Adverse events | From day 19 of induction therapy until the start of the second high-dose methotrexate regimen. | Comparison of adverse events in study and control groups |
| Healthcare costs | Six-month since window phase | Comparison of healthcare costs in study and control groups |
Other
| Measure | Time frame | Description |
|---|---|---|
| Effects of Blinatumomab on immune function | From the day of or before Blinatumomab to 3-7 days after termination of Blinatumomab. | Immune cell subgroup, T-cell activation, depletion, and cytokine releasing will be studied before Blinatumomab and day 7 and day 14 during Blinatumomab, and 1 week after Blinatumomab discontinuation. |
Countries
China
Contacts
Primary ContactShuhong Shen, PhD/MD
Backup ContactWenting Hu, MD
Outcome results
None listed