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

NCT06257394 | Recruiting Phase 2

• 1 other identifier: H-2401-028-1500
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 6

Brief Summary

Very high-risk acute lymphoblastic leukemia

Conditions

Acute Lymphoblastic Leukemia, Pediatric

Keywords

VHR ALL; NGS-MRD

Outcome Measures

Primary Outcomes (1)

• Event free survival

  Up to 5 years

Secondary Outcomes (5)

• Overall survival

  Up to 5 years

• Recurred rate

  Up to 5 years

• Death rate related to infusion

  Up to 5 years

• Adverse Event

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

• The rate of Hematopoietic stem cell transplantation

  Up to 5 years

Study Arms (2)

[Arm A, Dasatinib(Sprycel) Arm]

EXPERIMENTAL

▪ 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.

Drug: Dasatinib(Sprycel) arm

[Arm B, Non-Dasatinib(Sprycel) Arm]

EXPERIMENTAL

▪ 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

Drug: Non-Dasatinib(Sprycel) arm

Interventions

Dasatinib(Sprycel) arm DRUG

▪ 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.

[Arm A, Dasatinib(Sprycel) Arm]

Non-Dasatinib(Sprycel) arm DRUG

▪ 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

[Arm B, Non-Dasatinib(Sprycel) Arm]

Eligibility Criteria

• Age: 1 Year - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hyoung Jin Kang: lead
• Asan Medical Center: collaborator
• Samsung Medical Center: collaborator
• Severance Hospital: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator

Study Sites (6)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Seoul saint Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Hyoung Jin Kang, Ph.D

CONTACT

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

Hyoung Jin Kang

CONTACT

+82220723452; kanghj@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 14, 2024
• Study Start: October 20, 2024
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 31, 2034
• Last Updated: June 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)