treatment of pediatric very high-risk acute lymphoblastic leukemia in korea

Conditions: Acute Lymphoblastic Leukemia, Pediatric

Summary: very high-risk acute lymphoblastic leukemia

* arm a : philadelphia chromosome-positive : induction (except consolidation #3 using blinatumomab, all administration should be given with dasatinib.) * morphologic complete remission after the induction : consolidation #1 → consolidation #2 → consolidation #3 1. if minimal residual disease \& qpcr not detected after the post-consolidation #1 : consolidation #3 using high dose methotrexate, high dose cytarabine → di(delayed intensification) #1 → im(interim maintenance) #2 → di(delayed intensification) #2 → maintenance 2. if minimal residual disease or qpcr(quantitative polymerase chain reaction) positivie after the post-consolidation #1 : consolidation #3 using blinatumomab →allogeneic hsct(hematopoietic stem cell transplantation) * m2 or m3 after the induction : re-induction → consolidation #2 → consolidation #3 → allogeneic hsct(hematopoietic stem cell transplantation) 1. if minimal residual disease \& qpcr(quantitative polymerase chain reaction) not detected after the post-consolidation #1 : consolidation #3 using high dose methotrexate, hd cytarabine 2. if minimal residual disease or qpcr(quantitative polymerase chain reaction) positivie after the post-reinduction : consolidation #3 using blinatumomab * in arm a, except consolidation #3 using blinatumomab, all administration should be given with dasatinib. * arm b : other vhr all except philadelphia chromosome-positive : induction * morphologic complete remission after the induction : consolidation #1 → consolidation #2 → consolidation #3 1. if minimal residual disease not detected after the post-consolidation #1 : consolidation #3 using high dose methotrexate, high dose cytarabine → allogeneic hsct(hematopoietic stem cell transplantation) 2. if minimal residual disease positivie after the post-consolidation #1 : consolidation #3 using blinatumomab →allogeneic hsct(hematopoietic stem cell transplantation) * m2 or m3 after the induction : re-induction → consolidation #2 → consolidation #3 → allogeneic hsct(hematopoietic stem cell transplantation) 1. if minimal residual disease not detected after the post-consolidation #1 : consolidation #3 using high dose methotrexate, high dose cytarabine 2. if minimal residual disease positivie after the post-reinduction : consolidation #3 using blinatumomab

Eligibility criteria:
inclusion criteria: * pediatric patients diagnosed with all between the ages of 1 and 19 years at the time of diagnosis who meet one or more of the following conditions: * philadelphia chromosome-positive t(9;22)(q34;q11) or * patients with failed remission who had blast \> 5% on bone marrow test after initial remission induction therapy or * hypodiploidy (number of chromosomes \&lt; 44 (less than 44)) or * e2a-hlf(hepatic leukemia factor) translocation-positive or * when the prognosis is judged to be poor according to ngs-mrd results among high-risk all patients (i) in b-all, the ngs-mrd(next generation sequencing-minimal residual disease) after consolidation therapy is 0.01% or more, and the ngs-mrd followed during interim maintenance treatment is also 0.01% or more, (ii) in t-all, ngs-mrd(next generation sequencing-minimal residual disease) is more than 0.01% after consolidation therapy exclusion criteria: * participants with contraindications to medications * when the study participant or their legal representative withdraws consent * pregnant or lactating women (patients of child-bearing potential require adequate contraception during the study period) * participants who are medically unsuitable to participate in this study at the discretion of the investigator participants participating in other interventional studies other than this protocol

Keywords: vhr all ngs-mrd