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Clinical Trials/NCT06257394
NCT06257394RecruitingPhase 2

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

Hyoung Jin Kang11 sites in 2 countries74 target enrollmentStarted: October 20, 2024Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
74
Locations
11
Primary Endpoint
Event free survival
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Year to 19 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

[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.

Intervention: Dasatinib(Sprycel) arm (Drug)

[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

Intervention: Non-Dasatinib(Sprycel) arm (Drug)

Outcomes

Primary Outcomes

Event free survival

Time Frame: Up to 5 years

Secondary Outcomes

  • 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)
  • Overall survival(Up to 5 years)

Investigators

Sponsor
Hyoung Jin Kang
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Hyoung Jin Kang

Professor

Seoul National University Hospital

Study Sites (11)

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