Ma-Spore ALL 2020 Study

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.

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