The primary objective of this trial is to improve the overall survival rate of children and young adult with B-lineage acute lymphoblastic leukemia (B-ALL) in Singapore and Malaysia in the context of a multicenter cooperative trial using a risk-stratified therapy.
This is a multicenter open-label phase II study involving children and young adult (\< 41 years old) who are newly diagnosed with B-ALL and treatment naïve. There will be 3 parallel cohorts whose risk to be stratified based upon leukemia genetics profiles and patient's treatment response: 1. Standard Risk (SR) 2. Intermediate Risk (IR) 3. High Risk (HR) All drugs being used are commercially available chemotherapy drugs. There will be no novel chemotherapeutic agent without marketing authorization being tested in this trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
Subang Jaya Medical Centre
Kuala Lumpur, Malaysia
RECRUITINGUniversity Malaya Medical Centre
Kuala Lumpur, Malaysia
RECRUITINGKK Women's and Children's Hospital
Singapore, Singapore
RECRUITINGOverall survival (OS)
OS is calculated from the date of diagnosis to the date of last follow-up or any death
Time frame: 5 years from diagnosis
Event free survival (EFS)
EFS will be calculated from the date of diagnosis of ALL to date of last follow-up or to the first event, including relapse, resistant disease, second malignancy and death
Time frame: 5 years from diagnosis
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Oral/ intrathecal/intravenous/subcutaneous
Intramuscular
Intravenous
Optional for those allergic to E.coli/PEG L-asparaginase (intravenous)
Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)
Indicated only for ALL with BCR::ABL1 /BCR::ABL1-like/ tyrosine kinase fusion positive (oral)
Intravenous
Subcutaneous/ Intravenous
Oral
Oral
Intravenous
Intravenous
Intravenous