Newly-diagnosed Pediatric T-cell ALL Protocol

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Feb 25, 2025

Keywords

ClinConnect Summary

The Newly-diagnosed Pediatric T-cell ALL Protocol is a clinical trial designed to explore new treatment options for children and teenagers diagnosed with T-cell acute lymphoblastic leukemia (T-ALL), a type of cancer that affects the blood and bone marrow. Researchers want to find out if adding three new medications—dasatinib, venetoclax, and homoharringtonine—can help more patients achieve remission (meaning no signs of cancer) and stay cancer-free longer. This study will take place at multiple centers in China and aims to improve the overall outcomes for young patients with this challenging condition.

To participate in the trial, children must be between 1 month and 17 years old and have a confirmed diagnosis of T-ALL through specific tests. However, those with other types of leukemia or certain health conditions, like severe heart problems or major infections, may not be eligible. Families can expect that if their child joins the trial, they will receive close monitoring and care throughout the study. It's important to know that the trial is not yet recruiting participants, so it will start enrolling patients soon.

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 T-ALL by immunophenotyping.
• Exclusion Criteria:
• • 1. B-ALL
• • 2. AML
• • 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)
• • 10. Any significant comorbidities or psychiatric disorders that may impact patient safety, compliance, informed consent, study participation, follow-up, or the interpretation of study results. In such cases, all participating sites must report directly to the PI to determine whether the patient meets exclusion criteria.
• • 11. Severe malnutrition, active infections, heart failure, or chemotherapy intolerance.