Tests risk-based treatment for children with relapsed acute lymphoblastic leukemia
Tests risk-grouped treatment, including blinatumomab, in children with relapsed leukemia.
Plain-language title generated from the registry record
Registry title: Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Key facts
- Where
- Daegu, Daejeon, Hwasun, Jeju City, Seoul, and Yangsan, South KoreaSee the 10 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 22 years old?
Source: NCT05827549, who can take part
Where in South Korea
- Kyungpook National University Chilgok HospitalDaegu, South KoreaNot yet recruiting
- Chungnam National University HospitalDaejeon, South KoreaNot yet recruiting
- Chonnam National University Hwasun HospitalHwasun, South KoreaTaking people
- Jeju National University HospitalJeju City, South KoreaNot yet recruiting
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Seoul National University HospitalSeoul, South KoreaTaking people
- Seoul saint Mary's HospitalSeoul, South KoreaTaking people
- Severance hospitalSeoul, South KoreaTaking people
- Pusan National University Yangsan HospitalYangsan, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ho Joon Im
- Trial code
- NCT05827549
- Record updated
- 29 July 2026
- Original description
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.Read full original descriptionShow less
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
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.
Inclusion: Patients <= 1 year and >22 years of age at the time of relapse will be eligible; Participants must have a histologic diagnosis of acute lymphoblastic leukemia:; 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); Patients who have never received allogeneic stem cell transplant; Patients who have never received blinatumomab before; Adequate Renal Function; -A serum creatinine based on age/gender as follows:; 1 to \< 2 years - Male (0.6) Female (0.6) 2 to \< 6 years - Male (0.8) Female (0.8) 6 to \< 10 years - Male (1) Female (1) 10 to \< 13 years - Male (1.2) Female (1.2) 13 to \< 16 years - Male (1.5) Female (1.4); ≥ 16 years - Male (1.7) Female (1.4); Adequate Liver Function defined as a direct bilirubin \<3.0 mg/dL; Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram; Lansky (age \< 16 years) or Karnofsky (age ≥ 16 years) performance status ≥ 60% at screening; Patients with a life expectancy of 1 or more year; Patients who are expected to comply with all required study procedures and follow the study protocol in the opinion of the investigator; Signed written informed consent and assent forms must be obtained prior to any study procedures.
Exclusion: In case of relapsed within 1 month after the end of induction with the same 4-drug therapy used in this study; patient who was relapsed within 1 month after the end of induction therapy with the same 4-drug regimen to be used in this study; Female patients who are not proved as infertile or pregnant (Evidence of infertility: History taking of possibilities of pregnancy or urine human chorionic gonadotrophin test negative, amenorrhea more than a year, Natural or artificial (Ex.hormone therapy) menopause status more than a year, surgical sterilization(Ex.Hysterectomy or ovariotomy etc); Currently receiving treatment in another investigational drug study or clinical trial; Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome; Patients with known HIV; Evidence of unstable conditions that would pose a risk to subject safety or interfere with the patients\' compliance; Patients with clinically relevant central nervous system (CNS) pathology or active CNS involvement including: unstable epilepsy, uncontrolled seizure, paralysis, aphasia, history of severe brain injury, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder; Known hypersensitivity to drugs or components to be administered: Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, Blinatumomab; 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; Patients with mixed phenotype leukemia.