Actively Recruiting
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Led by Ho Joon Im · Updated on 2025-06-06
90
Participants Needed
7
Research Sites
456 weeks
Total Duration
On this page
Sponsors
H
Ho Joon Im
Lead Sponsor
S
Samsung Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Treatment Efficacy According to Risk Group in Relapsed Childhood Acute Lymphoblastic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged between 1 year and 22 years at the time of relapse
- Diagnosed with acute lymphoblastic leukemia: either precursor B-cell (B-ALL) or precursor T-cell (T-ALL)
- First relapse of acute lymphoblastic leukemia involving bone marrow, including combined extramedullary relapse
- Blast cells in bone marrow less than 5% for certain types as defined
- No prior allogeneic stem cell transplantation
- Never received blinatumomab before
- Adequate kidney function according to age and gender specific serum creatinine levels
- Adequate liver function with direct bilirubin less than 3.0 mg/dL
- Adequate heart function with shortening fraction ≥ 27% or ejection fraction ≥ 50% by echocardiogram
- Lansky or Karnofsky performance status ≥ 60% at screening
- Life expectancy of one year or more
- Expected to comply with study procedures and protocol
- Signed informed consent and assent forms obtained before any study procedures
You will not qualify if you...
- Diagnosis of Burkitt leukemia/lymphoma or mature B-cell leukemia
- Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia
- CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia
- Relapse within 1 month after end of induction therapy with the same 4-drug regimen used in this study
- Mixed phenotype leukemia
- Genetic syndromes such as Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or bone marrow failure syndromes
- Known HIV infection
- Female patients who are not infertile or are pregnant
- Currently enrolled in another investigational drug study or clinical trial
- Unstable conditions posing safety risks or affecting compliance
- Clinically relevant central nervous system disorders or active CNS involvement such as uncontrolled seizures or severe brain injury
- Known allergies to study drugs including Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, or Blinatumomab
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Chonnam National University Hwasun Hospital
Hwasun, South Korea, 58128
Actively Recruiting
2
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
3
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
4
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
5
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
6
Seoul saint Mary's Hospital
Seoul, South Korea, 06591
Actively Recruiting
7
Pusan National University Yangsan Hospital
Yangsan, South Korea, 50612
Actively Recruiting
Research Team
H
Ho Joon Im
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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