Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Phase 2RecruitingNCT06257394

Hyoung Jin Kang74 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Interventions

Dasatinib(Sprycel) armDRUG

▪ Arm A : Philadelphia chromosome-positive : Induction (Except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.) * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → DI #1 → IM #2 → DI #2 → Maintenance 2. If MRD or qPCR positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3 → Allogeneic HSCT 1. If MRD \& qPCR not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD or qPCR positive after the post-reinduction : Consolidation #3 using Blinatumomab * In Arm A, except Consolidation #3 using Blinatumomab, all administration should be given with Dasatinib.

Non-Dasatinib(Sprycel) armDRUG

▪ Arm B : Other VHR ALL except Philadelphia chromosome-positive : Induction * Morphologic CR after the Induction : Consolidation #1 → Consolidation #2 → Consolidation #3 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine → Allogeneic HSCT 2. If MRD positive after the post-consolidation #1 : Consolidation #3 using Blinatumomab →Allogeneic HSCT * M2 or M3 after the Induction : Re-induction → Consolidation #2 → Consolidation #3‡ → Allogeneic HSCT 1. If MRD not detected after the post-consolidation #1 : Consolidation #3 using HD MTX, HD Cytarabine 2. If MRD positive after the post-reinduction : Consolidation #3 using Blinatumomab

Eligibility

Sex: ALLMin age: 1 YearMax age: 19 Years

Medical Language ↔ Plain English

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 \< 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

Locations (10)

Kyungpook National University Chilgok-Hospital

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Outcomes

Primary Outcomes

Event free survival

Time frame: Up to 5 years

Secondary Outcomes

Overall survival

The time until defined by date of all-cause mortality from the date of 1st infusion

Time frame: Up to 5 years

Recurred rate

As the period from enrollment to disease progression/recurrence

Time frame: Up to 5 years

Death rate related to infusion

The time until defined by date of drug-related mortality from the date of 1st infusion

Time frame: Up to 5 years

Adverse Event

Time frame: From Day 1 of the clinical trial to 28 days after last drug administration

The rate of Hematopoietic stem cell transplantation

The rate of Hematopoietic stem cell transplantation after the Induction and consolidation therapy

Time frame: Up to 5 years

Central Contacts

Hyoung Jin Kang, Ph.D

CONTACT

+82-2-2072-3452 kanghj@snu.ac.kr

Hyoung Jin Kang

CONTACT

+82220723452 kanghj@snu.ac.kr

Data from ClinicalTrials.gov

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