Treatment of Newly Diagnosed High Risk Pediatric Acute Lymphoblastic Leukemia

NCT06184009 | Recruiting Phase 2

• 1 other identifier: 2023-3626-0001
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 7

Brief Summary

1. 1.BM MRD \< 0.01% : IM #1 → DI #1 → IM #2 → Maintenance
2. 2.BM MRD ≥ 0.01% : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance
3. 3.BM MRD ≥ 0.01% after Consolidation
4. 4.T cell ALL : Change to very high risk regimen
5. 5.Pre-B ALL : IM #1 → Intensification
6. 6.BM MRD \< 0.01% after IM #1 : DI #1 → IM #2 → DI #2 → Maintenance
7. 7.BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen
8. 8.Difference in the number of \'interim maintenance(IM)\' and \'delayed intensification(DI)\' is important for chemotherapies based on MRD.

Conditions

Pediatric Acute Lymphoblastic Leukemia

Keywords

HR ALL; NGS-MRD

Outcome Measures

Primary Outcomes (1)

• Event Free Survival

  Event-free survival rate for 5 years from the date of registration

  Up to 5 years

Secondary Outcomes (3)

• Overall Survival

  Up to 5 years

• Recurred rate

  Up to 5 years

• Death rate related to infusion

  Up to 5 years

Study Arms (1)

ALL, High risk with DI #2(Doxorubicin)

EXPERIMENTAL

* Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \&lt; 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% after Induction, \&lt; 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \&lt; 0.01% after IM #1 : Continue with \&#39;No. 2\&#39; of High risk regimen starting with DI #1 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.

Drug: ALL, High risk

Interventions

ALL, High risk DRUG

Intervention Description : * Clinical and genetic factors consistent with High risk : Induction → Consolidation 1. BM MRD \&lt; 0.01% after both Induction and Consolidation : IM #1 → DI #1 → IM #2 → Maintenance 2. BM MRD ≥ 0.01% after Induction, \&lt; 0.01% after Consolidation : IM #1 → DI #1 → IM #2 → DI #2 → Maintenance 3. BM MRD ≥ 0.01% after Consolidation <!-- --> 1. T cell ALL : Change to very high risk regimen 2. Pre-B ALL : IM #1 → Intensification 1. BM MRD \&lt; 0.01% after IM #1 : Continue with \&#39;No. 2\&#39; of High risk regimen starting with DI #1 2. BM MRD ≥ 0.01% after IM #1 : Change to Very high risk regimen * T cell ALL patients with M1 BM post-Consolidation will start IM #1. However, the patients will switch to Very high risk regimen at the next chemotherapy cycle once post-Consolidation MRD ≥ 0.01% has been reported.

ALL, High risk with DI #2(Doxorubicin)

Eligibility Criteria

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

You may qualify if:

• Age: 1year\~19years of age at diagnosis
• Patients who are newly diagnosed Pre-B ALL and meet one of the following criteria
• High-risk group according to the National Cancer Institute (NCI)/Rome: Age greater than or equal to 10 years and less than 19 years at diagnosis, or white blood cell count greater than or equal to 50 x 10\^9/L at diagnosis
• If extra-bone marrow lesions are identified at the time of diagnosis, Central nervous system involvement (CNS3) or testicular involvement
• High-risk gene variants:
• KMT2A rearrangement intrachromosomal amplification of chromosome 21 (iAMP21)
• ● If subjects are under the age of 10 at the time of diagnosis and took steroids for more than 24 hours within two weeks before the diagnosis, the risk group will be determined by the presence of a whole blood test within three days before starting steroids. If a whole blood test is performed within three days before beginning steroids, the risk group will be assessed based on the white blood cell count in the test. If there is no whole blood test before starting steroids, subjects are classified as a high-risk group. If subjects are ten or older at diagnosis, pre-diagnosis steroid treatment will not affect the risk classification.
• Newly diagnosed T cell ALL

You may not qualify if:

• Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia
• Patients with Down syndrome
• potential of pregnancy or during pregnancy (patients of childbearing age need adequate contraception for the duration of the trial)
• Patients who have already received steroid treatment for newly diagnosed ALL specified in the above selection criteria or chemotherapies more than one intrathecal cytarabine treatment
• Participating in an interventional clinical trial other than this research

Sponsors & Collaborators

• Jae Wook Lee: lead
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Severance Hospital: collaborator
• Pusan National University Yangsan Hospital: collaborator
• Korea University Anam Hospital: collaborator

Study Sites (7)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

RECRUITING

Samsung Medical Center

Seoul, Seoul, South Korea

RECRUITING

Korea University Anam Hospital

Seoul, 02841, South Korea

NOT YET RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Seoul saint Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

AIEOP acute lymphoblastic leukemia protocol

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

Study Officials

• Jae Wook Lee, Ph.D

  The Catholic University of Korea

  STUDY CHAIR

Central Study Contacts

Jae Wook Lee, Ph.D

CONTACT

82-2-2258-6192; dashwood@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 28, 2023
• Study Start: August 10, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)