Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children

Lymphoblastic Leukemia in Children Clinical Trial

Official title:

Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06099366
• Other study ID #: 2023-09-142
• Status: Recruiting
• Phase: Phase 2
• Start date: March 5, 2024
• Est. completion date: December 31, 2033

Study information

• Verified date: May 2024
• Source: Samsung Medical Center
• Contact: Hee Young Ju, MD, Phd
• Phone: 82-2-3410-0865
• Email: heeyoung.ju[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 9 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed pediatric/adolescent acute lymphomblastic leukemia patient with NCL standard risk that stratifies all 1-5 of following

1. 1 year old = Age < 10 years old

2. white blood cell at initial diagnosis < 5x10^10/L (50,000uL)

3. CNS 1 or 2

4. No testis involvement

5. 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

C. Cardiac function i. Shortening fraction = 27% confirmed by cardiac echography ii. Ejection fraction = 50% confirmed by cardiac echography

Exclusion Criteria:

• Steroid administration within 2 weeks before the registration

• t(9;22) or t(4;11)(q11;q23) or chromosome < 44 or iAMP21 or t(17;19)/TCF3-HLF

• One of the following syndromes: Down syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or other bone marrow failure syndrome

• Burkitt leukemia/lymphoma

• When the clinical trial subject(or legal representative) does not consent or is unable to give written consent

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Lymphoblastic Leukemia in Children
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine Intrathecal Methotreate
• Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000U/m2 Intrathecal Methotrexate
• Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
• Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
• Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal Methotrexate
• Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2 Dexamethasone 10mg/m2 Intrathecal Methotrexate
• Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
• Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul	Other (Non U.s.)
Korea, Republic of	Samsung Medical Center	Seoul	Other (Non U.s.)

Sponsors (1)

Lead Sponsor	Collaborator
Hee Young Ju

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	5-year event free survival rate		Up to 5-years
Secondary	Confirmation of the therapeutic effect of the initial treatment response	Relapse-free survival between two groups(NGS-MRD positive vs. NGS MRD negative after induction) offsets by NGS MRD based stratified treatment	Up to 5-years
Secondary	Disease prognosis-related factor	Relapse-free survival according to presence or absence of known good prognosis factors(high hyperdilpoidy, ETV6/RUNX1, Trisomy 4/10/17) have no clinical significance when NGS MRD based stratified treatment is performed.	Up to 5-years