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.
The Risk Assessment is classified as follows based on the NGS-MRD results evaluated after EOI(End of Induction). \<Standard Risk\> * Late (Relapse ≥ 1 year after off treatment) B-ALL marrow or Combined relapse AND * End of induction MRD \< 0.01% \<High Risk\> * T-ALL marrow or combined relapse (any timing) * All other B-ALL marrow or combined relapse cases \<Very High Risk\> • End of Induction BM ≥ M2 AND B -ALL marrow or combined relapse
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
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
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
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
Kyungpook National University Chilgok Hospital
Daegu, South Korea
NOT_YET_RECRUITINGChungnam National University Hospital
Daejeon, South Korea
NOT_YET_RECRUITINGChonnam National University Hwasun Hospital
Safety/Efficacy
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.
Time frame: through study completion, an average of 9 year
Disease-free survival rate (Blinatumomab)
Blinatumomab is used before transplantation to patients with high-risk group, and then disease-free survival rate will be compared before and after
Time frame: through study completion, an average of 9 year
Disease-free survival rate (standard risk)
Patients with standard risk who are not eligible for allogenic stem cell transplantation are given consolidation and maintenance therapies, and disease-free survival rate will compared before and after
Time frame: through study completion, an average of 9 year
Disease-free survival rate (Comparing minimal residual disease)
Comparing minimal residual disease negative rate with the study before by adding blinatumomab to patients in high risk group
Time frame: through study completion, an average of 9 year
Death rate related to treatment
Children and adolescents who have relapsed acute lymphoblastic leukemia re administered different treatments depending on their assigned groups, and disease-free survival rate will be compared before and after
Time frame: through study completion, an average of 9 year
Death rate related to toxicity
Comparing remission rate and occurrence rate of toxicity during re-intervention therapy after changed schedules of idarubicin
Time frame: through study completion, an average of 9 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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 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 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 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 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
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)
All matters related to hematopoietic stem cell transplantation are subject to each institution's practice.
Hwasun, South Korea
Jeju National University Hospital
Jeju City, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGAsan Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGSeoul saint Mary's Hospital
Seoul, South Korea
RECRUITINGPusan National University Yangsan Hospital
Yangsan, South Korea
RECRUITINGToxicity rate during consolidation therapy
Checking occurence rate of toxicity related to treatment during consolidation for patients in low-risk group
Time frame: through study completion, an average of 9 year