RecruitingPhase 2NCT05827549

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

Sponsor

Ho Joon Im

Enrollment

90 participants

Start Date

Apr 4, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoid Leukemia

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

Min Age: 1 YearMax Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing new treatment combinations for children and young adults with acute lymphoblastic leukemia (ALL — a blood cancer) that has come back after initial treatment. The study assigns treatment intensity based on the patient's risk level. **You may be eligible if...** - You are between 1 year and 22 years old at the time of relapse - You have been diagnosed with B-cell or T-cell ALL - This is your first relapse and the cancer has returned in the bone marrow - You have not previously had a bone marrow transplant from a donor - You have not previously received blinatumomab - Your heart, kidney, and liver function meets the required thresholds - Your performance status (ability to function) is at least 60% on the Karnofsky or Lansky scale **You may NOT be eligible if...** - You have Burkitt leukemia or Philadelphia chromosome-positive ALL - Your cancer cells do not have the CD19 surface marker (relevant for B-cell ALL) - You have had a prior donor stem cell transplant - Your organ function is significantly impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGReinduction(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

DRUGCosolodation 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

DRUGConsolidation 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

DRUGBlinatumomab 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)

DRUGBlinatumomab 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)

DRUGBlinatumomab-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)

DRUGBlinatumomab-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)

DRUGIntensification 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

DRUGMaintenance(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)

PROCEDUREStem Cell Transplantation

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