A Phase 3 Study to Evaluate Marqibo® in the Treatment of Subjects ≥ 60 Years Old With Newly Diagnosed ALL

Inclusion Criteria: Have provided written, signed, and dated informed consent to participate in the study, inaccordance with the International Council on Harmonisation of Technical Requirements forRegistration of Pharmaceuticals for Human Use Good Clinical Practice (ICH GCP) Guideline E6and all applicable local regulations. Are age >or=60 years (at the time of providinginformed consent). Have newly diagnosed, histologically proven, untreated Philadelphia chromosome-negative (Ph-) Acute lymphocytic leukemia [ALL], with >or= 5% bone marrow blasts. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Have a lifeexpectancy >or= 3 months. Have renal and liver function as defined below within 14 days, inclusive, prior to studyenrollment, unless the abnormality is considered attributable to leukemia: Total bilirubin ≤ 2.0 x the upper limit of normal (ULN), unless the subject has a knowndiagnosis of Gilbert's disease Aspartate transaminase (AST, Serum glutamic oxaloacetictransaminase [SGOT]) or alanine transaminase (ALT, Serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x ULN Serum creatinine ≤ 1.5 x ULN. Not have had major surgery within 4 weeksbefore the planned start of treatment. If female, are post-menopausal, surgically sterilized, or willing to use acceptable methodsof birth control (eg, hormonal contraceptive, intra-uterine device, diaphragm withspermicide, condom with spermicide, or abstinence) from the screening visit through 30 daysafter the last dose of any protocol defined chemotherapeutic agents. If male and sexually active with a partner of child-bearing potential, agree to use anacceptable barrier method for contraception from the screening visit through 30 days afterthe last dose of any protocol defined chemotherapeutic agents. Have the ability and willingness to fully comply with study procedures and restrictions.

Exclusion Criteria: Has had prior systemic chemotherapy (for ALL or other malignancy). Has had priorvincristine for any reason. Is planning to undergo stem cell transplantation (SCT) as anypart of first-line therapy for ALL. Has Burkitt's lymphoma/leukemia. Has Philadelphia chromosome-positive (Ph+) ALL and/orBCR/ABL rearrangements documented by fluorescent in-situ hybridization (FISH),cytogenetics, or polymerase chain reaction (PCR). Has active central nervous system (CNS) disease. Has ongoing neuropathy of any etiology >Grade 1. Has a history of persistent active neurologic disorders including demyelinatingform of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, and otherdemyelinating conditions. Prior hydroxyurea (Hydrea®) for the management of any condition other than leukocytosis orprior hydroxyurea of >7 days duration for the management of leukocytosis (hydroxyurea forthe management of leukocytosis must be planned to be tapered off before or on Day 5 ofInduction). Has received prior steroids within 7 days before beginning protocol-specified Inductiontherapy for reasons other than leukocytosis (steroids for the management of leukocytosisare allowed but must be planned to be tapered off before or on Day 5 of Induction). Has an active serious infection not controlled by oral or IV antibiotics or antifungals. Has received any investigational therapy within 28 days before beginning anyprotocol-defined chemotherapeutic treatment.