Evaluating Blinatumomab for Pediatric B-Lymphoblastic Leukemia

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

This study is testing if a new treatment called Blinatumomab can help children with newly diagnosed acute B-Lymphoblastic leukemia who didn't respond well to their first round of chemotherapy.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 1 Month to 18 Years
• Sex: All
• Sponsor: Shanghai Jiao Tong University School of Medicine (Academic / other)
• Drugs / interventions: chemotherapy, Blinatumomab
• Locations: 4 sites (Hefei, Anhui and 3 other locations)
• Trial ID: NCT06607419 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy of Blinatumomab in children with newly diagnosed acute B-Lymphoblastic leukemia who have shown a poor response to initial chemotherapy. Participants will receive a 14-day treatment of Blinatumomab, with their bone marrow evaluated before and after the treatment to determine the rate of minimal residual disease (MRD) negativity. The study will compare the outcomes of these patients to historical controls to evaluate the effectiveness of the treatment.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 month to under 18 years diagnosed with acute B-lymphoblastic leukemia and exhibiting specific MRD levels after initial chemotherapy.

Not a fit: Patients with certain exclusions such as Down's syndrome, CNS involvement, or those who have received specific prior treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for pediatric patients with B-Lymphoblastic leukemia who do not respond well to standard chemotherapy.

How similar studies have performed: Other studies have shown promising results with Blinatumomab in similar patient populations, indicating potential for success in this approach.

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%.

Where this trial is running

Hefei, Anhui and 3 other locations

• Anhui Provincial Children's Hospital — Hefei, Anhui, China (Not_yet_recruiting)
• Fujian Children's Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Shanghai Children's Medical center — Shanghai, Shanghai Municipality, China (Recruiting)
• Ningbo Women and Children's Hospital — Ningbo, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Shuhong Shen, PhD/MD

Conditions B-Cell Lymphoblastic Leukemia; Children; Blinatumomab