Efficacy Study of Blinatumomab Clean Up Early Residual Disease for Newly Diagnosed Pediatric B Lymphoblastic Leukemia (BBClean)

Shanghai Jiao Tong University School of Medicine

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

B-Cell Lymphoblastic Leukemia

Treatments

Drug: Blinatumomab

Study type

Interventional

Funder types

Other

Identifiers

NCT06607419

CBC-ALL2024-1

Details and patient eligibility

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.

Enrollment

90 estimated patients

Sex

All

Ages

1 month to 18 years old

Volunteers

No Healthy Volunteers

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%.