Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia
Condition: Leukemia, Myeloid, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Outpatient Care Model; CPX-351
Intervention description: Outpatient care model includes a nurse teacher educational program, scheduled outpatient visit protocol, and quality of life surveys for both subjects and caregivers.; CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
Intervention MeSH terms: Cytarabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Myeloid Leukemia; Outpatient; CPX-351; Vyxeos®; Leukemia

Summary:

      This is a single-arm, single-site run-in phase (six subjects) followed by a multicenter
      continuation phase (114 subjects), Phase IV study. Eligible subjects will be receiving
      CPX-351 as their usual medical care administered according to FDA approval, as a condition
      for participation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects with newly diagnosed acute myeloid leukemia who are eligible for treatment
             with CPX-351 therapy according to the FDA approval and indication: therapy-related AML
             (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

          2. Age ≥ 18 years

          3. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 (or Karnofsky
             Performance Status equivalent of 70 or above).

          4. Total bilirubin ≤ 3 mg/dL.

          5. Creatinine clearance > 30 mL/min by Cockcroft/Gault equation.

          6. Adequate cardiac function, as assessed by ejection fraction( ≥50% for anthracycline
             therapy) via multiple-gated acquisition (MUGA) or echocardiogram.

          7. Total white blood cell count of ≤ 20,000/µL on peripheral blood assessment (hydrea
             and/or leukapheresis allowed).

          8. No evidence of active, uncontrolled infection.

          9. No evidence of clinically significant disseminated intervascular coagulation (DIC)

         10. No clinically significant abnormalities in core vital signs like heart rate, blood
             pressure or oxygenation which require inpatient evaluation or monitoring.

         11. In the opinion of the enrolling physician, the subject is not at risk for clinically
             significant tumor lysis syndrome based on clinical assessment, complete blood count
             (CBC), comprehensive metabolic panel (CMP), uric acid, and lactate dehydrogenase
             (LDH).

         12. In the opinion of the enrolling physician, no medical conditions that preclude the
             subject or the primary caregiver from transportation to and from the outpatient
             clinical care facility.

         13. Both subject and the identified primary caregiver(s) signed informed consent.

         14. In the opinion of the enrolling physician, there are no medical contraindications to
             outpatient induction and management.

         15. Male subjects, even if surgically sterilized (i.e., status post vasectomy), must agree
             to one of the followings:

               -  Practice effective barrier contraception during the entire study period and
                  through six months after the last dose of CPX-351, OR

               -  Agree to practice true abstinence when this is in line with the preferred and
                  usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation,
                  symptothermal, postovulation methods] and withdrawal are not acceptable methods
                  of contraception.)

        Female subjects must meet one of the followings:

          -  Postmenopausal for at least one year before enrollment, OR

          -  Surgically sterile (i.e., undergone a hysterectomy or bilateral oophorectomy), OR

          -  If the subject is of childbearing potential (defined as not satisfying either of the
             above two criteria), she must agree to practice two acceptable methods of
             contraception (combination methods require use of two of the following: diaphragm with
             spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom,
             hormonal contraceptive) from the time of signing of the informed consent form through
             six months after the last dose of CPX-351, OR o Agree to practice true abstinence when
             this is in line with the preferred and usual lifestyle of the subject. (Periodic
             abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and
             withdrawal are not acceptable contraception methods.)

        Logistical Inclusion Criteria

          1. The subject must be able to reside within approximately 45 minutes of the hospital
             where induction therapy is administered, during normal driving conditions (in the
             opinion of the enrolling physician), until count recovery or 60 days post-treatment,
             whichever comes first

          2. The enrolling physician must verify and attest that the subject has a primary
             caregiver meeting all the following criteria:

               -  Reside with the subject.

               -  Be able to care for the subject full time or arrange to share full-time care with
                  secondary caregivers.

               -  Provide transportation.

               -  Respond to clinical issues that arise.

               -  Communicate with subject and physician in a timely manner.

          3. The nurse teacher must verify that the subject and primary caregiver have completed
             and adequately understand the study-dictated nurse teacher educational program.

          4. The nurse teacher must verify the subject and primary caregiver have capacity to
             comply with outpatient management program.

          5. The subject must have reliable, working telephone access.

          6. The subject must be willing and able to attend all protocol-dictated visits and be
             seen frequently as an outpatient at the clinical care facility where induction therapy
             is administered.

        Exclusion Criteria:

          1. Pregnant women (per pregnancy test in women of childbearing potential) or women who
             are breast-feeding.

          2. Subjects currently receiving any investigational agents.

          3. Subjects must not have current evidence of another malignancy that requires treatment.

          4. Subjects diagnosed with Wilson's disease and/or copper-related metabolic disorders.