Clinical trial NCT06607419: Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Official title: Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: B-Cell Lymphoblastic Leukemia
Keywords: Children
B-Cell Lymphoblastic Leukemia
Blinatumomab
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Fujian Children's Hospital
name: Zhangzhou Affiliated Hospital of Fujian Medical University
name: Guizhou Provincial People's Hospital
name: The First Affiliated Hospital of Xiamen University
name: Dalian Women and Children's Medical Center
name: The Third Xiangya Hospital of Central South University
name: Hunan Provincial People's Hospital
name: Ningbo Women & Children's Hospital
name: Anhui Provincial Children's Hospital
name: Jiangxi Province Children's Hospital
name: Yuying Children's Hospital of Wenzhou Medical University
First posted: 2024-09-23
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%.

Primary outcomes:
measure: The flow cytometric MRD
timeFrame: From the date of Blinatumomab completion to one week after its treatment course
measure: The NGS- MRD
timeFrame: From the date of Blinatumomab completion to one week after its treatment course
Secondary outcomes:
measure: 5-year EFS
timeFrame: 5 years since the last recruited patient completed Blinatumomab.
measure: Adverse events
timeFrame: From day 19 of induction therapy until the start of the second high-dose methotrexate regimen.
measure: Healthcare costs
timeFrame: Six-month since window phase
Other outcomes:
measure: Effects of Blinatumomab on immune function
timeFrame: From the day of or before Blinatumomab to 3-7 days after termination of Blinatumomab.
Locations:
city: Hefei
country: China
facility: Anhui Provincial Children's Hospital
state: Anhui
city: Fuzhou
country: China
facility: Fujian Children's Hospital
state: Fujian
city: Shanghai
country: China
facility: Shanghai Children's Medical center
state: Shanghai
city: Ningbo
country: China
facility: Ningbo Women and Children's Hospital
state: Zhejiang
Study officials:
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