Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial, called CCCG-ALL2025 LR-B-ALL, is designed to help children who have recently been diagnosed with a specific type of leukemia called low-risk B-cell acute lymphoblastic leukemia (B-ALL). The trial is studying a treatment that combines a medication called blinatumomab (often shortened to Blina-14) with standard chemotherapy. The goal is to see if this combination helps children achieve better recovery outcomes compared to traditional treatments. The trial is looking for participants who are between 1 and 18 years old and have been diagnosed with low-risk B-ALL.

If your child joins this trial, they will receive blinatumomab for 14 days as part of their treatment plan, followed by additional chemotherapy. The researchers will monitor their progress closely, using advanced testing methods to measure how well the treatment is working. It's important to note that some children may not be eligible for the trial if they have certain other health conditions or previous treatments. This trial is not yet recruiting participants, but it's a promising opportunity for families looking for new treatment options for low-risk B-ALL.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Must meet all items below:
• • 1. Age older than 1 year and younger than 18 years.
• • 2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
• • 3. Diagnosis of B-ALL by immunophenotyping.
• • 4. Low risk group
• Exclusion Criteria:
• Should be excluded in the presence of any item below:
• • 1. T-ALL
• • 2. I/HR B-ALL group
• • 3. sIgM+
• • 4. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
• • 5. Philadelphia chromosome positive ALL (Ph-ALL)
• • 6. ALL evolved from chronic myeloid leukemia (CML).
• • 7. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
• • 8. Secondary leukemia
• • 9. Known underlying congenital immunodeficiency or metabolic disease
• • 10. Congenital heart disease with cardiac insufficiency.
• • 11. Glucocorticoid treatment 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)