Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- event-free survival of SER group
Study Overview
Brief 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.
Detailed Description
Purpose of the study
- For slow early responder (SER), to confirm if the augmented interim maintenance using intravenous high dose methotrexate will improve the treatment outcome.
- For slow early responder (SER), to confirm if removal of prophylactic radiotherapy will relieve long term complications.
- To predict the treatment response and prognosis high risk pediatric ALL by monitoring of minimal residual disease (MRD).
Inclusion criteria
-
Diagnosis
-
Newly diagnosed B-precursor ALL meeting criteria 1.2
-
Newly diagnosed B-precursor ALL who was previously treated with steroid.
-
Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Newly diagnosed B-precursor ALL meeting criteria 1.2
- •Newly diagnosed B-precursor ALL who was previously treated with steroid.
- •Newly diagnosed T cell ALL, excluding early T-cell precursor (ETP) leukemia
- •1.2 Initial WBC count
- •from 1 years old to 9 years old : WBC ≥ 50,000/μL
- •from 10 years old to 21 years old : Any WBC
- •from 1 years old to 21 years old : Any WBC with Testicular leukemia or CNS leukemia (CNS3)
Exclusion Criteria
- •Philadelphia chromosome (+) or bcr/abl rearrangement (+)
- •Chromosome <45 by cytogenetics
- •Induction failure (Day 28 M3 marrow (>25% blasts))
- •t(4:11) (as identified by cytogenetics, FISH or molecular studies)
- •Early T-cell precursor leukemia
- •Down syndrome ALL
Arms & Interventions
Slow early responder group
Includes : SER, Testis(+), CNS 3, T-cell (non ETP), Initial PB WBC ≥ 100,000/μL
- SER Consolidation
- Intrathecal triple chemotherapy at d0, 7, 14, 21 2. SER Interim Maintenance #1
- high dose methotrexate included
- Intrathecal triple chemotherapy at d0, 28 3. SER Delayed Intensification #1
- Intrathecal triple chemotherapy at d0, 28, 35 4. SER Interim Maintenance #2
- high dose methotrexate included
- Intrathecal triple chemotherapy at d0, 28 5. SER Delayed Intensification #2
- Intrathecal triple chemotherapy at d0, 28, 35 6. SER Maintenance
- Intrathecal triple chemotherapy at d0
Intervention: high dose methotrexate (Drug)
Slow early responder group
Includes : SER, Testis(+), CNS 3, T-cell (non ETP), Initial PB WBC ≥ 100,000/μL
- SER Consolidation
- Intrathecal triple chemotherapy at d0, 7, 14, 21 2. SER Interim Maintenance #1
- high dose methotrexate included
- Intrathecal triple chemotherapy at d0, 28 3. SER Delayed Intensification #1
- Intrathecal triple chemotherapy at d0, 28, 35 4. SER Interim Maintenance #2
- high dose methotrexate included
- Intrathecal triple chemotherapy at d0, 28 5. SER Delayed Intensification #2
- Intrathecal triple chemotherapy at d0, 28, 35 6. SER Maintenance
- Intrathecal triple chemotherapy at d0
Intervention: Intrathecal triple chemotherapy (Drug)
Outcomes
Primary Outcomes
event-free survival of SER group
Time Frame: 5 years from diagnosis
Secondary Outcomes
- Number of adverse events(5 years from diagnosis)
Investigators
Hee Young Shin
KSPHO
The Korean Society of Pediatric Hematology Oncology
