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Recruiting NCT06257394

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

Phase II Interventional Acute Lymphoblastic Leukemia, Pediatric

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dasatinib(Sprycel) arm, Non-Dasatinib(Sprycel) arm.
Who it may be relevant to
Registry conditions: Acute Lymphoblastic Leukemia, Pediatric. Basic parameters: 1 year — 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multi-center Clinical Trial for Optimal Treatment of Pediatric Very High-risk Acute Lymphoblastic Leukemia in Korea

Overview

Very high-risk acute lymphoblastic leukemia

Detailed description

* 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

Interventions

  • Drug Dasatinib(Sprycel) arm
    ▪ 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 →Al
  • Drug Non-Dasatinib(Sprycel) arm
    ▪ 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

Primary outcome measures

  • Event free survival [Time frame: Up to 5 years]
Secondary outcome measures (5)
  • Overall survival [Time frame: Up to 5 years]
  • Recurred rate [Time frame: Up to 5 years]
  • Death rate related to 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 [Time frame: Up to 5 years]

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 \< 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 10 centers
  • Kyungpook National University Chilgok-Hospital — Daegu
  • Chungnam National University Hospital — Daejeon
  • Chonnam National University Hwasun Hospital — Hwasun
  • Jeju National University Hospital — Jeju City
  • Seoul National University Hospital — Seoul
  • Severance Hospital — Seoul
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul
  • … and 2 more centers

Identifiers

NCT: NCT06257394 · H-2401-028-1500

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗