ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016

Prior treatment

• Any previous treatment with cytotoxic chemotherapy excluding treatment for TAM or radiation therapy. Patient pre-treated with short term steroid (\< 7 days of duration within last 1 month prior to treatment start) can be enrolled into this study.
• Any serious uncontrolled medical condition or impending end organ dysfunction that would impair the ability of the subject to receive protocol therapy, including:
  • History of coronary arterial disease, cardiomyopathy, heart failure, arrhythmia (other than sinus arrhythmia) or severe cardiac malformation which with residual abnormalities or requires further major corrective surgery within 2 years.
  • Ongoing uncontrolled hypertension.
  • Ongoing uncontrolled diabetes mellitus.
  • Ongoing uncontrolled infection.
  • History of congenital or acquired immunodeficiency including HIV infection.
  • History of interstitial pneumonia, pulmonary fibrosis, bronchiectasis or severe pulmonary emphysema.
  • CNS hemorrhage.
  • Psychiatric disorder.
  • Other concurrent active neoplasms.
• Doubtful compliance or ability to complete study therapy due to financial, social, familial or geographic reason, or in the judgement of site investigator.

Other illness

• Second malignancy.

Lab values

• Renal dysfunction with creatinine \>2x upper limit of normal (ULN). Patients whose creatinine has improved to \<2x ULN before treatment commencement can enrol subject to discretion of site PI.
• Liver dysfunction with direct bilirubin \> 5x ULN.

Other

• Philadelphia positive ALL.
• Mature B-ALL.
• Mixed phenotype acute leukemia.
• Pregnant or lactating women.

• Down syndrome diagnosed clinically or cytogenetically (including Mosaic Down)
• Newly diagnosed ALL according to WHO 2016 classification.
• Age \< 21 years old at time of enrollment.
• ECOG performance status (PS) score of 0-2.
• Written informed consent obtained from legally acceptable representatives.