Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jan 1, 2025

Keywords

ClinConnect Summary

The CCCG-ALL-2025 clinical trial is focused on improving treatment for children diagnosed with intermediate or high-risk B-cell acute lymphoblastic leukemia (B-ALL), a type of cancer that affects the blood and bone marrow. This study aims to enhance the chances of survival and quality of life for these young patients while minimizing side effects and the need for bone marrow transplants. The trial will compare two different treatment approaches to see which is more effective at reducing the presence of cancer cells in the blood, which is an important measure of how well the treatment is working.

To be eligible for this trial, children must be between 1 month and 17 years old and have a confirmed diagnosis of B-ALL. Certain children, such as those with low-risk leukemia or specific health conditions, may not be able to participate. Those who join the trial will receive closely monitored treatment and can help researchers learn more about how to improve care for future patients with this condition. This is an important step towards finding better therapies for childhood leukemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age older than 1 month to younger than 18 years.
• • 2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
• • 3. Diagnosis of B-ALL by immunophenotyping.
• Exclusion Criteria:
• • 1. Low-risk ALL
• • 2. sIgM+
• • 3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
• • 4. ALL evolved from chronic myeloid leukemia (CML).
• • 5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
• • 6. Secondary leukemia
• • 7. Known underlying congenital immunodeficiency or metabolic disease
• • 8. Congenital heart disease with cardiac insufficiency.
• • 9. 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)