Acute Lymphoblastic Leukemia (ALL) Clinical Trials

• Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell)

• Bone marrow involvement with ≥20% lymphoblasts

• Age ≥ 60 Years

∙ OR

• Patients with relapsed or refractory acute lymphoblastic leukemia (B-cell or T-cell) defined as receiving one or more cytotoxic containing regimens

• Bone marrow involvement with ≥5% lymphoblasts

• Age ≥ 18 Years

• Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Refer to Appendix D)

• Adequate organ function

‣ Serum total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease

⁃ Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless clearly due to disease involvement

⁃ Creatinine clearance \>50 mL/min (calculated according to institutional standards or using Cockcroft-Gault or Modification of Diet in Renal Disease (MDRD) formula)

• Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to the first dose of study drugs and must agree to use an effective contraception method during the study and for 30 days following the last dose of study drug. Women of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug

• Patients or their legally authorized representative must provide written informed consent