Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-22
SponsorHo Joon Im

About this trial

This study is open-label, multi-center, prospective study, which targets childhood patients with relapsed acute lymphostatic leukemia including bone marrow recurrence. Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for relapsed acute lymphoblastic leukemia in children and adolescents.

Eligibility criteria

Qualifiers

Patients <= 1 year and >22 years of age at the time of relapse will be eligible

B-ALL: Precursor B-cell acute lymphoblastic leukemia

T-ALL: Precursor T-cell acute lymphoblastic leukemia

1st recurred acute lymphoblastic leukemia patients, recurred parts including marrow. Enrolling patients with combined extra medullary relapse including bone marrow is acceptable. (No limits for extra medullary site) Additionally, subjects whose blast cells in bone marrow are less than 5% (ALL whether type M2 or M3 must be definite)

Disqualifiers

Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia

Patients with Philadelphia chromosome positive (Ph+) ALL

Patients with CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia (non-expression of CD19 in peripheral blood or bone marrow by flow cytometry) are not eligible for administration of Blinatumomab

In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study

Trial design

Treatments tested in this trial

  • Reinduction(4weeks)
  • Cosolodation 1st(3weeks)
  • Consolidation 2nd(3weeks)
  • Blinatumomab 1st(High Risk Group)_4 Weeks
  • Blinatumomab 2nd (High Risk Group)_4 Weeks
  • Blinatumomab-Salvage 1st (Very High Risk Group)_4 Weeks
  • Blinatumomab-Salvage 2nd (Very High Risk Group)_4 Weeks
  • Intensification course
  • Maintenance(12 Weeks/Cycle)
  • Stem Cell Transplantation

Treatment groups

90 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Ho Joon Im

Lead sponsor

Asan Medical Center

Sponsor institution

Samsung Medical Center

Collaborator

Seoul National University Hospital

Collaborator

Severance Hospital

Collaborator

Chonnam National University Hospital

Collaborator

Pusan National University Yangsan Hospital

Collaborator

Seoul St. Mary's Hospital

Collaborator