Overview
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.
Description
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:
- Standard Risk (SR)
- Intermediate Risk (IR)
- 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.
Eligibility
Inclusion Criteria:
- Has been diagnosed with B-lineage ALL as evidenced by:
- BMA blasts > 20% AND
- Leukemic process in the bone marrow, peripheral blood or any extra medullary tissue with confirmation of B-lymphoid differentiation by flow immunophenotyping or histopathologically
- Age < 41 years of age at enrolment
- Written informed consent obtained from patient or legally acceptable representative (LAR)
Exclusion Criteria:
- T-lineage ALL
- Down syndrome with ALL
- History of previous malignancies or this ALL is a second malignancy
- Mixed phenotype acute leukemia (MPAL) or undifferentiated leukemia
- Mature B-cell leukemia/lymphoma
- Any previous cytotoxic therapy (chemotherapy/radiotherapy/immunotherapy). Patient pre-treated with short term steroid (< 7 days of duration within last 1 month prior to ALL treatment start) may be enrolled after discussion and written approval from PI. These patients should be treated on at least intermediate arm.
- Persistent renal dysfunction with creatinine more than upper limit of normal for age before start of induction therapy. Patients requiring temporary dialysis without persistent renal dysfunction can qualify.
- Liver dysfunction with direct bilirubin > 10x upper normal limit for age.
- Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy
- Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator