Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia

Inclusion Criteria:

- Willing and able to provide written informed consent/assent for the trial.

- Be ≥ 18 years of age on day of signing informed consent.

- Able to adhere to the study visit schedule and other protocol requirements.

- Pathologically confirmed B- or T-cell acute lymphoblastic leukemia, with >5%
peripheral blood or bone marrow lymphoblasts and/or extramedullary disease >1x1cm.

- Relapsed or refractory acute lymphoblastic leukemia after at least 1 prior cycle of
therapy. Patients with Philadelphia chromosome positive disease must have failed at
least two prior tyrosine kinase inhibitors.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

- Cardiac ejection fraction ≥ 50% by echocardiography or multigated acquisition scan
(MUGA).

- Must be at least 2 weeks out from any prior systemic chemotherapy, blinatumumab,
radiation, and/or other investigational agents, and have recovered to grade 1 from any
toxicity related to prior therapy. Glucocorticoids are permitted up to 1 day prior to
the first dose.

- Serum bilirubin and creatinine less than 1.5x upper limit of normal (ULN). AST and ALT
must be less than 3x ULN, unless there is liver involvement.

- Females of childbearing potential (FCBP) must have a negative serum pregnancy test at
screening. A FCBP is considered when a sexually mature female: 1) has not undergone a
hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal
for at least 12 consecutive months.

- A FCBP must agree to use of two methods of highly effective contraception, be
surgically sterile, or abstain from heterosexual activity for the course of the study
through 30 days after the last dose of study treatment.

- Male participants must agree to use an adequate method of contraception starting with
the first dose of study therapy through 30 days after the last dose of study therapy.
Men must agree to not donate sperm during and after the study

Exclusion Criteria:

- Clinical evidence of active central nervous system (CNS) leukemia.

- Any major surgery or radiation therapy within four weeks.

- Any active infection requiring systemic therapy, including HIV, Hepatitis B, and/or
Hepatitis C.

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the subject's
participation for the full duration of the trial, or is not in the best interest of
the subject to participate, in the opinion of the treating investigator (including but
not limited to severe graft-versus-host disease, unstable angina, pulmonary
hypertension, or severe CHF (NYHA III-IV).

- Patients with active (uncontrolled, metastatic) second malignancies.

- Is pregnant or breastfeeding, or expecting to conceive or father children within the
projected duration of the trial, starting with the screening visit through 30 after
the last dose of trial treatment.

- Hypersensitivity to cytarabine, daunorubicin, or liposomal products.

- History of Wilson's disease or other copper-metabolism disorder.

- Patients with prior cumulative anthracycline exposure of greater than 368 mg/m^2
daunorubicin or equivalent).