BL-8040 and Nelarabine for Relapsed or Refractory T-Acute Lymphoblastic Leukemia/ Lymphoblastic Lymphoma

Inclusion Criteria:

- Diagnosis of T-acute lymphoblastic leukemia/ lymphoblastic lymphoma according to WHO
criteria which has relapsed or is refractory to chemotherapy.

- Peripheral blood lymphoblasts ≤ 50,000 mcL. Hydroxyurea and/or leukapheresis is
permitted to reduce the peripheral blast count prior to enrollment and treatment.

- Age ≥ 18 years

- ECOG performance status ≤ 2.

- Adequate organ function defined as:

- Calculated creatinine clearance ≥ 50 ml/min using the Cockroft-Gault formula

- AST, ALT, total bilirubin ≤ 2 x institutional ULN except for Gilbert's disease or
when in the opinion of treating physician elevated levels are due to direct
involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to
leukemia), in which case ALT and AST may be elevated up to ≤ 5 x IULN.

- Women of childbearing potential and men must agree to use adequate contraception with
a highly effective method (hormonal or barrier method of birth control, abstinence)
prior to study entry and for the duration of study participation. Abstinence is
acceptable if this is the established and preferred contraception for the subject.

- Female subjects must have a negative urine or serum pregnancy test within 72 hours
prior to start of study treatment if of childbearing potential or be of
non-childbearing potential. If the urine test is positive or cannot be confirmed as
negative, a serum pregnancy test will be required. The serum pregnancy test must be
negative for the subject to be eligible. Non-childbearing potential is defined as:

*≥ 45 years of age and has not had menses for > 2 years

- Amenorrheic for > 2 years without a hysterectomy and oophorectomy and a FSH value
in the postmenopausal range upon pretrial (screening) evaluation

- Post-hysterectomy, oophorectomy, or tubal ligation. Documented hysterectomy or
oophorectomy must be confirmed with medical records of the actual procedure or
confirmed by an ultrasound. Tubal ligation must be confirmed with medical records
of the actual procedure.

- Able to understand and willing to sign an IRB-approved written informed consent
document.

Exclusion Criteria:

- Previous treatment with nelarabine for relapsed or refractory disease.

- Pregnant or nursing.

- Received any other investigational agent or systemic cytotoxic chemotherapy within the
preceding 2 weeks.

- Active CNS involvement with leukemia

- Active HIV or hepatitis B or C infection.

- Any medical condition which, in the opinion of the clinical investigator, would
interfere with the evaluation of the patient. Subjects with a clinically significant
or unstable medical or surgical condition or any other condition that cannot be
well-controlled by the allowed medications permitted in the study protocol that would
preclude safe and complete study participation, as determined by medical history,
physical examinations, laboratory tests, and according to the investigator's judgment.