NCT02339350

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 15, 2015

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

8.3 years

First QC Date

January 12, 2015

Last Update Submit

January 15, 2015

Conditions

Acute Lymphoblastic LeukemiaChild

Outcome Measures

Primary Outcomes (1)

  • event-free survival of SER group

    5 years from diagnosis

Secondary Outcomes (1)

  • Number of adverse events

    5 years from diagnosis

Study Arms (2)

Rapid early responder group

NO INTERVENTION

1. RER Consolidation BM exam on day 63: M1, M2 -\> IM M3 or residual CNS ds or Bx proven extramedullary ds - off protocol 2. RER Interim Maintenance #1 3. RER Delayed Intensification 4. RER Interim Maintenance #2 5. RER Maintenance (12 weeks=84 days)

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

Drug: high dose methotrexateDrug: Intrathecal triple chemotherapy

Interventions

high dose methotrexateDRUG

HD-MTX IV 5,000 mg/m2 I.V. over 4hr on day 0, 14, 28, 42 of SER interim maintenance schedule

Slow early responder group
Intrathecal triple chemotherapyDRUG

Intrathecal triple chemotherapy for SEG group instead of radiotherapy

Slow early responder group

Eligibility Criteria

Age1 Year - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • \. 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
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University, College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
KSPHO

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 15, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

January 16, 2015

Record last verified: 2015-01

Locations

KR(1)