Ireland
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Recruiting Phase 2

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

NCT05827549 · tracked via the Priya Life Science South Korea tracker
Sponsor
Ho Joon Im
Phase
Phase 2
Started
2024-04-04
Last updated
2026-07-29

Condition(s) studied

Acute Lymphoid Leukemia

Investigational drug(s) / intervention(s)

Reinduction(4weeks)Cosolodation 1st(3weeks)Consolidation 2nd(3weeks)Blinatumomab 1st(High Risk Group)_4 WeeksBlinatumomab 2nd (High Risk Group)_4 WeeksBlinatumomab-Salvage 1st (Very High Risk Group)_4 WeeksBlinatumomab-Salvage 2nd (Very High Risk Group)_4 WeeksIntensification courseMaintenance(12 Weeks/Cycle)Stem Cell Transplantation

Reinduction(4weeks): Prednisolone 60 mg/m2/day tid days 1-28, Vincristine 1.5 mg/m2 on days 1, 8, 15, 22, L-asparaginase 6,000 IU/m2(days 2-4 start, total 9 doses for 3 weeks), Idarubicin 10 mg/m2 on days 1, 8, (15\~17), IT Ara-C on days 1, IT MTX on days 8, 29

Cosolodation 1st(3weeks): Ifosfamide: 1.8 g/m2 (days 1, 2, 3, 4, 5), Etoposide: 100 mg/m2 (days 1, 2, 3, 4, 5), IT MTX on day 1

Consolidation 2nd(3weeks): MTX: 500 mg/m2 over 30 min followed by 1,000 mg/m2 over 23.5 hr (day 1), Ara-C: 3,000 mg/m2/dose (day 2, 3), IT MTX on day 1

Blinatumomab 1st(High Risk Group)_4 Weeks: Blinatumomab 15 mcg/m²/day(Days: 1-28), Dexamethasone 5 mg/m2/dose on Day 1, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)

Blinatumomab 2nd (High Risk Group)_4 Weeks: Blinatumomab 15 mcg/m²/day(Days: 1-28), IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)

Blinatumomab-Salvage 1st (Very High Risk Group)_4 Weeks: Blinatumomab 9 mcg/day(Weight ≥ 45kg) or 5 mcg/m²/day(Weight \< 45kg) on 1-7 days, 28 mcg/day(Weight ≥ 45kg) or 15 mcg/m²/day(Weight \< 45kg) on 8-28 days, Dexamethasone 5 mg/m2/dose on day 1 and day 8, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)

Blinatumomab-Salvage 2nd (Very High Risk Group)_4 Weeks: Blinatumomab 28 mcg/day(Weight ≥ 45kg) or 15 mcg/m²/day(Weight \< 45kg) on 1-28 days, IT MTX on day 15, 29 (CNS 1, 2 patients), TIT on day 15, 29 (CNS 3 patient)

Intensification course: \<Intensification 1st(3 Weeks)\> Etoposide: 100 mg/m2 on day 1, 2, 3, Ifosfamide 3.4 g/m2 on day 1, 2, 3 \<Intensification 2nd(2 Weeks)\> Oral 6-mercaptopurine 50 mg/m2/day PO (days 1-14), Methotrexate: 25 mg/m2 on day 1, 8, TIT on day 1 \<Intensification 3rd(3 Weeks)\> Ara-C 1.0 g/m2 (days 1-3), Idarubicin: 5mg/m2 (days 1- 3) \<Intensification 4th(2 Weeks)\> Dexamethasone 8 mg/m2/day on days 1-14, Vincristine 2 mg/m2 on days 1 and 8, L-asparaginase 10,000 IU/m2 on days 1 and 8

Maintenance(12 Weeks/Cycle): Prednisolone: 15 mg/m²/dose(Days 1-5, 29-33, 57-61), Vincristine: 1.5 mg/m²/dose(Day 1, 29, 57), Oral 6-mercaptopurine: 50 mg/m²/dose (Days 1-84), Methotrexate: 20 mg/m²/dose (Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78), Intrathecal methotrexate (Day 1)

Stem Cell Transplantation: All matters related to hematopoietic stem cell transplantation are subject to each institution's practice.

Study summary

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

Sex
ALL
Min age
1 Year
Max age
22 Years
Healthy volunteers
No
Inclusion Criteria: * 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 \&lt; 2 years - Male (0.6) Female (0.6) 2 to \&lt; 6 years - Male (0.8) Female (0.8) 6 to \&lt; 10 years - Male (1) Female (1) 10 to \&lt; 13 years - Male (1.2) Female (1.2) 13 to \&lt; 16 years - Male (1.5) Female (1.4) ≥ 16 years - Male (1.7) Female (1.4) * Adequate Liver Function defined as a direct bilirubin \&lt;3.0 mg/dL * Adequate Cardiac Function defined as: Shortening fraction of ≥ 27% by echocardiogram, or Ejection fraction of ≥ 50% by echocardiogram * Lansky (age \&lt; 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 Criteria: * 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 * Patients with mixed phenotype leukemia * 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. * Patients with genetic syndrome: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman syndrome bone marrow failure syndrome * Patients with known HIV * 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 * Evidence of unstable conditions that would pose a risk to subject safety or interfere with the patients\&#39; 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

Primary outcome measure(s)

  • Safety/Efficacy — through study completion, an average of 9 year
    Patients with relapsed acute lymphoblastic leukemia are being treated after sorted into groups with their potential risk, and disease-free survival rate will be checked.

Trial sites (10)

FacilityCityRegionStatus
Kyungpook National University Chilgok Hospital Daegu South Korea Not Yet Recruiting
Chungnam National University Hospital Daejeon South Korea Not Yet Recruiting
Chonnam National University Hwasun Hospital Hwasun South Korea Recruiting
Jeju National University Hospital Jeju City South Korea Not Yet Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Asan Medical Center Seoul South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Seoul saint Mary's Hospital Seoul South Korea Recruiting
Pusan National University Yangsan Hospital Yangsan South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05827549 on ClinicalTrials.gov ↗ ← All trials in South Korea