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
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