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Clinical Trials/NCT02339350
NCT02339350UnknownPhase 2

Treatment of Newly Diagnosed High Risk Acute Lymphoblastic Leukemia in Children

The Korean Society of Pediatric Hematology Oncology1 site in 1 country110 target enrollmentStarted: January 2015Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Sponsor
Enrollment
110
Locations
1
Primary Endpoint
event-free survival of SER group
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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

  1. For slow early responder (SER), to confirm if the augmented interim maintenance using intravenous high dose methotrexate will improve the treatment outcome.
  2. For slow early responder (SER), to confirm if removal of prophylactic radiotherapy will relieve long term complications.
  3. To predict the treatment response and prognosis high risk pediatric ALL by monitoring of minimal residual disease (MRD).

Inclusion criteria

  1. Diagnosis

  2. Newly diagnosed B-precursor ALL meeting criteria 1.2

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

  4. 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

Experimental

Includes : SER, Testis(+), CNS 3, T-cell (non ETP), Initial PB WBC ≥ 100,000/μL

  1. 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

Experimental

Includes : SER, Testis(+), CNS 3, T-cell (non ETP), Initial PB WBC ≥ 100,000/μL

  1. 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

Sponsor
The Korean Society of Pediatric Hematology Oncology
Sponsor Class
Network
Responsible Party
Principal Investigator
Principal Investigator

Hee Young Shin

KSPHO

The Korean Society of Pediatric Hematology Oncology

Study Sites (1)

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