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
N/A
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 research aims to evaluate treatment outcomes based on risk groups using next-generation sequencing minimal residual disease (NGS MRD) for children and adolescents with relapsed acute lymphoblastic leukemia (ALL), including cases with bone marrow recurrence. The study is open-label, prospective, and involves multiple centers, focusing on how risk stratification can guide therapy for this condition. Patients are classified into standard, high, and very high risk groups based on NGS MRD results after induction therapy and relapse characteristics. Participants receive treatment according to their risk category, involving multiple phases such as reinduction, consolidation, intensification, maintenance, and in some cases, blinatumomab therapy or hematopoietic stem cell transplantation (HSCT). Treatment regimens include specific chemotherapy drugs and schedules tailored to standard, high, very high risk groups, and T-cell ALL. The study includes repeated intensification courses and possible stem cell transplantation according to institutional practices. Throughout the study, participants undergo evaluations of safety and efficacy over an average of nine years. Researchers monitor disease-free survival rates, toxicity rates, and death rates related to treatment and toxicity. Assessments include clinical performance status, renal, liver, and cardiac function tests, and monitoring of minimal residual disease. The study requires informed consent and adherence to protocol, with detailed follow-up to assess long-term outcomes and safety.
CONDITIONS
Brief 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 1 to 22 years at the time of relapse
- Histologic diagnosis of acute lymphoblastic leukemia (B-ALL or T-ALL)
- First relapse of acute lymphoblastic leukemia including bone marrow or combined extramedullary sites
- Blast cells in bone marrow less than 5%
- No prior allogeneic stem cell transplant
- No previous treatment with blinatumomab
- Adequate renal function based on age and gender specific serum creatinine levels
- Adequate liver function with direct bilirubin less than 3.0 mg/dL
- Adequate cardiac function with echocardiogram shortening fraction ≥ 27% or ejection fraction ≥ 50%
- Lansky or Karnofsky performance status ≥ 60% at screening
- Life expectancy of 1 year or more
- Expected compliance with study procedures and protocol
- Signed informed consent and assent forms obtained prior to study procedures
You will not qualify if you...
- Diagnosis of Burkitt leukemia/lymphoma or mature B-cell leukemia
- Philadelphia chromosome positive (Ph+) ALL
- CD19-negative recurrent progenitor B-cell acute lymphoblastic leukemia
- Relapse within 1 month after 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
- Known HIV infection
- Female patients who are not infertile or pregnant
- Current participation in another investigational drug study or clinical trial
- Unstable conditions posing safety risks or affecting compliance
- Clinically relevant central nervous system pathology or active CNS involvement
- Known hypersensitivity to study drugs Idarubicin, Etoposide, Ifosfamide, Cytarabine, Vincristine, Mercaptopurine, or Blinatumomab
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies by risk group; treatment phases range from 3 weeks to 12 weeks per cycle, repeated as specified in the protocol
Participants receive a series of drug treatments according to their risk group classification, including reinduction, consolidation, intensification, blinatumomab courses, maintenance therapy, and potential stem cell transplantation.
Multiple visits scheduled throughout each treatment phase depending on drug administration and risk group
Duration - Up to 9 years through study completion
Participants are monitored for safety and efficacy outcomes after completion of treatment, including long-term disease-free survival and toxicity assessments.
Periodic visits over several years for monitoring
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
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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