Trial Title:
Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in Children
NCT ID:
NCT06099366
Condition:
Lymphoblastic Leukemia in Children
Conditions: Official terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Cytarabine
Dexamethasone
Dexamethasone acetate
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Methotrexate
Vincristine
Asparaginase
Mercaptopurine
BB 1101
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
induction: vincristine, L-asparaginase, dexamethasone, intrathecal Ara-C, intrathecal Methotrexate
Description:
vincristine 1.5mg/m2 L-asparaginase 6,000U/m2 Dexamethasone 6mg/m2 Intrathecal Cytarabine
Intrathecal Methotreate
Arm group label:
Standard-average (SA)
Arm group label:
Standard-high 1 (SH1)
Arm group label:
Standard-high 2 (SH2)
Arm group label:
Standard-low (SL)
Intervention type:
Drug
Intervention name:
Consolidation: Vincristine, Mecaptopurine, Intrathecal Methotrexate
Description:
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2
L-asparaginase 6,000U/m2 Intrathecal Methotrexate
Arm group label:
Standard-low (SL)
Intervention type:
Drug
Intervention name:
Consolidation: Vincristine, Mecaptopurine, Cyclophosphamide, Cytarabine, L-asparaginase, Intrathecal Methotrexate
Description:
Vincristine 1.5mg/m2 Mecaptopurine 50mg/m2 Cyclophosphamide 1,000mg/m2 Cytarabine 75mg/m2
L-asparaginase 6,000IU/m2 Intrathecal Methotrexate
Arm group label:
Standard-average (SA)
Arm group label:
Standard-high 1 (SH1)
Arm group label:
Standard-high 2 (SH2)
Intervention type:
Drug
Intervention name:
Interim Maintenance(IM): Vincristine, Methotrexate, Intrathecal Methotrexate
Description:
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Intrathecal Methotrexate
Arm group label:
Standard-average (SA)
Arm group label:
Standard-low (SL)
Intervention type:
Drug
Intervention name:
Interim Maintenance(IM): Vincristine, Methotrexate, Mercaptopurine, Intrathecal Methotrexate
Description:
Vincristine 1.5mg/m2 Methotrexate 5,000mg/m2 Mecaptopurine: 25mg/m2 Intrathecal
Methotrexate
Arm group label:
Standard-high 1 (SH1)
Arm group label:
Standard-high 2 (SH2)
Intervention type:
Drug
Intervention name:
Delayed Intesification(DI): Vincristine, Mercaptopurine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Description:
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
Arm group label:
Standard-average (SA)
Arm group label:
Standard-low (SL)
Intervention type:
Drug
Intervention name:
Delayed Intesification(DI): Vincristine, L-asparaginase, Doxorubicin, Cyclophosphamide, Cytarabine, Dexamethasone, Intrathecal Methotrexate
Description:
Vincristine 1.5mg/m2 L-asparaginase 6,000IU/m2 Doxorubicin 25mg/m2 Cyclophosphamide
1,000mg/m2 Cytarabine 100mg/m2 Dexamethasone 6mg/m2 Intrathecal Methotrexate
Arm group label:
Standard-high 1 (SH1)
Arm group label:
Standard-high 2 (SH2)
Intervention type:
Drug
Intervention name:
Maintenance: Vincristine, Mercaptopurine, Methotrexate, Dexamethasone, Intrathecal Methotrexate
Description:
Vincristine 1.5mg/m2 Mercaptopurine 50mg/m2 Methotrexate 20mg/m2 Dexamethasone 6mg/m2
Intrathecal Methotrexate
Arm group label:
Standard-average (SA)
Arm group label:
Standard-high 1 (SH1)
Arm group label:
Standard-high 2 (SH2)
Arm group label:
Standard-low (SL)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
1 Year
Maximum age:
9 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Asan Medical Center
Address:
City:
Seoul
Zip:
03174
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hyery KIM, MD, PhD
Phone:
82-2-3010-3373
Email:
taban@hanmail.net
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
03174
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Hee Young Ju, MD, PhD
Phone:
82-2-3410-0865
Email:
heeyoung.ju@samsung.com
Contact backup:
Last name:
hyunjung Shin
Phone:
82-2-3410-6763
Email:
hjds.shin@samsung.com
Start date:
March 5, 2024
Completion date:
December 31, 2033
Lead sponsor:
Agency:
Hee Young Ju
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06099366
