Study to Test AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)

Inclusion Criteria:

• Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblasticleukemia (T-ALL) based on World Health Organization (WHO) classification. Note thatpatients who were diagnosed initially with lymphoblastic lymphoma but who haverelapsed with T-ALL are eligible

• Patients must have evidence of acute leukemia in their peripheral blood or bonemarrow. Patients must have >= 5% lymphoblasts in the peripheral blood or bone marrowwithin 14 days prior to registration. Patients with only extramedullary disease arenot eligible

• Patients must be refractory to or have relapsed following a standard inductionchemotherapy. A standard chemotherapy induction regimen is defined as any program oftreatment that includes:

• Vincristine and prednisone

• Vincristine and dexamethasone

• Cytarabine and anthracycline, or

• High dose cytarabine (defined as at least 1 gr/m2 per individual dose unlessadjustments were required for renal/liver function)

• Patients must have no evidence of central nervous system disease within 28 daysprior to registration based on CSF studies. Patients with clinical signs or symptomsconsistent with central nervous system (CNS) involvement must have a lumbar puncturewhich is negative for CNS involvement; the lumbar puncture must be completed within 28 days prior to registration. Note that the patients may receive intrathecalchemotherapy with the initial lumbar puncture

• Prior nelarabine therapy is not required. In addition, patients who receivenelarabine during initial induction or post-remission treatment are eligible only ifthe physician does not feel they would benefit from other, multi-agent chemotherapy

• Patients must be >= 18 years of age

• Patients must have a Zubrod performance status of 0-3

• Patients must have creatinine clearance > 30 mL/min within 14 days prior toregistration according to the Cockcroft Gault equation

• Patients must have direct bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to registration

• Patients must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal (ULN) or =< 5.0 x ULN (if thoughtto be related to leukemic involvement) within 14 days prior to registration

• Prothrombin time (PT)/partial thromboplastin time (PTT)/fibrinogen (as clinicallyindicated) (within 14 days prior to registration to obtain baseline measurements)

• From comprehensive metabolic panel: sodium, potassium, chloride, carbon dioxide (CO2), and blood urea nitrogen (BUN) (within 14 days prior to registration to obtainbaseline measurements)

• Patients with known human immunodeficiency virus (HIV)-infection are eligibleproviding they are on effective anti-retroviral therapy and have undetectable viralload at their most recent viral load test within 6 months prior to registration. (HIV viral load testing is required only for patients with known HIV infection)

• Patients with evidence of chronic hepatitis B virus (HBV) infection may be eligibleprovided that they have an undetectable HBV viral load within 28 days prior toregistration. Patients may be currently receiving HBV treatment. (HBV viral loadtesting is required only for patients with known HBV infection)

• Patients with known history of hepatitis C virus (HCV) infection may be eligibleprovided that they have an undetectable HCV viral load within in 28 days prior toregistration. Patients may be currently receiving treatment. (HCV viral load testingis required only for patients with known HCV infection)

• Patients must agree to have bone marrow and blood specimens submitted for MRDtesting

• Patients must be offered the opportunity to participate in specimen banking. Withpatient consent, residuals from specimens submitted will be retained and banked forfuture research

• Patients must be informed of the investigational nature of this study and must signand give written informed consent in accordance with institutional and federalguidelines

• As a part of the Oncology Patient Enrollment Network (OPEN) registration process thetreating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study hasbeen entered in the system

Exclusion Criteria:

• Patients must not have had chemotherapy or investigational agents within 14 daysprior to registration except for steroids, oral 6-mercaptopurine, oral methotrexate,vincristine, intrathecal chemotherapy, or hydroxyurea. For participants who havereceived radiation therapy, at least 7 days must have elapsed from the end ofradiation prior to registration and participants must not currently be experiencingtoxicities from radiation therapy.

• Patients must not have undergone allogeneic hematopoietic transplant within 90 daysprior to registration

• Patients must have no evidence of >= grade 2 acute graft versus host disease (GVHD)or moderate or severe limited chronic GVHD and must have no history of extensiveGVHD of any severity within 90 days prior to registration. Extensive GVHD is definedas 1) generalized skin involvement or 2) localized skin involvement and/or hepaticdysfunction plus liver histology or cirrhosis or involvement of eye or minorsalivary organ or oral mucosa or any other target organ

• Patients must not have systemic fungal, bacterial, viral or other infection that isnot controlled (defined as exhibiting ongoing signs/symptoms related to theinfection and without improvement, despite appropriate antibiotics or othertreatment) within 14 days prior to registration

• Patients must not be pregnant or nursing due to the teratogenic potential of thedrug used on this study. Females of reproductive potential must have a negativeserum pregnancy test within 14 days prior to registration. Women/men of reproductivepotential must have agreed to use an effective contraceptive method during and up to 6 months after treatment. A woman is considered to be of "reproductive potential" ifshe has had menses at any time in the preceding 12 consecutive months. In additionto routine contraceptive methods, "effective contraception" also includesheterosexual celibacy and surgery intended to prevent pregnancy (or with aside-effect of pregnancy prevention) defined as a hysterectomy, bilateraloophorectomy or bilateral tubal ligation. However, if at any point a previouslycelibate patient chooses to become heterosexually active during the time period foruse of contraceptive measures outlined in the protocol, he/she is responsible forbeginning contraceptive measures

• Patients must not have other active malignancies for which they have receivedtreatments within 6 months prior to registration excluding localized malignanciesthat do not require systemic treatment.