Actively Recruiting
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-09-23
90
Participants Needed
4
Research Sites
314 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
F
Fujian Maternity and Child Health Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 1 month to younger than 18 years.
- Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
- Immunophenotyping confirming acute B-lymphoblastic leukemia.
- Meet one of the following: provisional low-risk with day 19 MRD ≥ 0.1% or provisional intermediate-risk with day 19 MRD ≥ 0.01%.
- Ability of the subject or guardian to understand and accept the informed consent approved by the Ethics Committee.
You will not qualify if you...
- Presence of surface IgM positive (sIgM+).
- Leukemia evolved from chronic myeloid leukemia (CML).
- Down's syndrome or major congenital/hereditary disease with organ dysfunction.
- Other secondary leukemias.
- Central nervous system (CNS) involvement.
- History of epilepsy or convulsions within the last month.
- Known congenital immunodeficiency or metabolic disease.
- Congenital heart disease with cardiac insufficiency.
- Treatment with glucocorticoids for 14 days or more, ABL kinase inhibitors for over 7 days within one month before enrollment, or any chemotherapy/radiotherapy within 3 months before enrollment (except emergency radiotherapy).
- Initial diagnosis of high-risk leukemia.
- Day 46 MRD ≥ 1%.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Anhui Provincial Children's Hospital
Hefei, Anhui, China, 230051
Not Yet Recruiting
2
Fujian Children's Hospital
Fuzhou, Fujian, China, 350011
Not Yet Recruiting
3
Shanghai Children's Medical center
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
4
Ningbo Women and Children's Hospital
Ningbo, Zhejiang, China, 315012
Actively Recruiting
Research Team
S
Shuhong Shen, PhD/MD
CONTACT
W
Wenting Hu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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