Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children (SR ALL)

Hee Young Ju

Status and phase: Enrolling; Phase 2

Conditions: Lymphoblastic Leukemia in Children

Treatments: Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate; Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate; Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate; Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate; Drug: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate; Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate; Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate; Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT06099366

2023-09-142

Details and patient eligibility

About

Aim of this study is to investigate the outcome of NGS MRD based risk stratified treatment for high risk acute lymphoblastic leukemia in children and adolescents.

Enrollment: 116 estimated patients

Sex: All

Ages: 1 to 9 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

<Inclusion Criteria>

• Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-4 of following

  1. 1 year old ≤ Age < 10 years old
  2. white blood cell at initial diagnosis < 5x10^10/L (50,000uL)
  3. No testis involvement
  4. Satisfaction of following organ functions

A. Kidney function (satisfies i or ii) i. Creatinine clearance (or radioisotope-measured GFR) ≥ 70mL/min/1.73m2 ii. Creatinine value according to age/sec satisfies the following:

1 to < 2 years: Male: 0.6 / Female: 0.6, 2 to < 6 years: Male: 0.8 / Female: 0.8, 6 to < 10 years: Male: 1 / Female: 1, 10 to < 13 years: Male: 1.2 / Female: 1.2, 13 to < 16 years: Male: 1.5 / Female: 1.4, ≥ 16 years: Male: 1.7 / Female: 1.4 However, subjects who meet the selection criteria within 1 week before registration after receiving appropriate conservative treatment, including fluid therapy, can be registered.

B. Liver function i. Direct bilirubin < 3.0mg/dL

<Exclusion Criteria>

1. Steroid administration within 2 weeks before the registration
2. t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF
3. Newly diagnosed T cell ALL
4. One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome
5. Burkitt leukemia/lymphoma
6. In the presence of electrocardiographic findings suggesting uncontrolled cardiac dysfunction (e.g., unstable ischemia, symptomatic arrhythmia, congestive heart failure) or congenital long QT syndrome
7. When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

116 participants in 4 patient groups

Standard-low (SL)

Experimental group

Description:

Induction-\> SL Consolidation(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion-\> Interim Maintenance 2nd-\> Maintenance

Treatment:

Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate

Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate

Drug: Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate

Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate

Standard-average (SA)

Experimental group

Description:

Induction-\> SH Consolidation(4weeks)-\> Intensified Consolidation(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion-\> Interim Maintenance 2nd-\> Maintenance

Treatment:

Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate

Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate

Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate

Drug: Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate

Standard-high 1 (SH1)

Experimental group

Description:

Induction-\> SL Consolidation(4weeks)-\> Intesified Consolidattion(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion 1st-\> Interim Maintenance 2nd-\> Delayed Intestificaion 2nd-\> Maintenance

Treatment:

Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate

Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate

Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate

Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate

Standard-high 2 (SH2)

Experimental group

Description:

Induction-\> SH Consolidation(4weeks)-\> Intensified Consolidation(4weeks)-\> Interim Maintenance 1st-\> Delayed Intesificaion 1st-\> Interim Maintenance 2nd-\> Delayed Intestificaion 2nd-\> Maintenance

Treatment:

Drug: induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate

Drug: Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate

Drug: Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate

Drug: Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate

Drug: Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate