Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Treatment of pediatric acute lymphoblastic leukemia (ALL) has advanced and the overall survival exceeds 80% nowadays. However the overall survival of high risk ALL remains 75-90%, thus recent studies focus on treatment intensification according to the risk group. According to the previous reports, we designed a multicenter prospective trial for pediatric ALL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Korean Society of Pediatric Hematology Oncology
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

1. Diagnosis

1. Newly diagnosed B-precursor ALL meeting criteria 1.2

2. Newly diagnosed B-precursor ALL who was previously treated with steroid.

3. Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia

1.2 Initial WBC count

1. from 1 years old to 9 years old : WBC ≥ 50,000/μL

2. from 10 years old to 21 years old : Any WBC

3. from 1 years old to 21 years old : Any WBC with Testicular leukemia or CNS leukemia (CNS3)

Exclusion Criteria:

1. Philadelphia chromosome (+) or bcr/abl rearrangement (+)

2. Chromosome <45 by cytogenetics

3. Induction failure (Day 28 M3 marrow (>25% blasts))

4. t(4:11) (as identified by cytogenetics, FISH or molecular studies)

5. Early T-cell precursor leukemia

6. Down syndrome ALL