Trial Title:
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
NCT ID:
NCT06607419
Condition:
B-Cell Lymphoblastic Leukemia
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Blinatumomab
Conditions: Keywords:
Children
B-Cell Lymphoblastic Leukemia
Blinatumomab
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Blinatumomab
Description:
Recruited patients will receive Blinatumomab since day 29 of induction for 14 days.
Arm group label:
Blinatumomab
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.
Criteria for 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%.
Gender:
All
Minimum age:
1 Month
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Provincial Children's Hospital
Address:
City:
Hefei
Zip:
230051
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongjun Liu, MD
Phone:
13515657759
Email:
13515657759@126.com
Facility:
Name:
Fujian Children's Hospital
Address:
City:
Fuzhou
Zip:
350011
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hui Zhang, PhD/MD
Phone:
15821333007
Email:
zhanghui@scmc.com.cn
Facility:
Name:
Shanghai Children's Medical center
Address:
City:
Shanghai
Zip:
200127
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuhong Shen, PhD/MD
Phone:
86-21-38626161
Phone ext:
82077
Email:
shenshuhong@scmc.com.cn
Contact backup:
Last name:
Wenting Hu, MD
Phone:
13524836748
Email:
huwenting@scmc.com.cn
Investigator:
Last name:
Shuhong Shen, PhD/MD
Email:
Principal Investigator
Investigator:
Last name:
Wenting Hu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Changcheng Chen, MD
Email:
Sub-Investigator
Facility:
Name:
Ningbo Women and Children's Hospital
Address:
City:
Ningbo
Zip:
315012
Country:
China
Status:
Recruiting
Contact:
Last name:
Binfei Hu, MD
Phone:
13777028360
Email:
hbfdkc@sina.com
Start date:
May 21, 2024
Completion date:
May 31, 2030
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Collaborator:
Agency:
Fujian Children's Hospital
Agency class:
Other
Collaborator:
Agency:
Zhangzhou Affiliated Hospital of Fujian Medical University
Agency class:
Other
Collaborator:
Agency:
Guizhou Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Xiamen University
Agency class:
Other
Collaborator:
Agency:
Dalian Women and Children's Medical Center
Agency class:
Other
Collaborator:
Agency:
The Third Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Hunan Provincial People's Hospital
Agency class:
Other
Collaborator:
Agency:
Ningbo Women & Children's Hospital
Agency class:
Other
Collaborator:
Agency:
Anhui Provincial Children's Hospital
Agency class:
Other
Collaborator:
Agency:
Jiangxi Province Children's Hospital
Agency class:
Other
Collaborator:
Agency:
Yuying Children's Hospital of Wenzhou Medical University
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06607419
