The Feasibility of Safely Managing Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia (AML) in an Outpatient Environment
The Feasibility of Safely Managing Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia (AML) in an Outpatient Environment
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.
This is an open-label, non-randomized study of a non-drug intervention in subjects receiving CPX-351 as their usual medical care administered according to its FDA approval. The study intervention is the application of a prescribed outpatient care model, including a nurse teacher educational program and quality of life surveys for both subjects and caregivers, in subjects who meet medical and logistical criteria. Induction therapy and medical follow-up are performed without prophylactic admission to an inpatient facility.
Inclusion Criteria:
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).
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 (or Karnofsky Performance Status equivalent of 70 or above).
Total bilirubin ≤ 3 mg/dL.
Creatinine clearance > 30 mL/min by Cockcroft/Gault equation.
Adequate cardiac function, as assessed by ejection fraction( ≥50% for anthracycline therapy) via multiple-gated acquisition (MUGA) or echocardiogram.
Total white blood cell count of ≤ 20,000/µL on peripheral blood assessment (hydrea and/or leukapheresis allowed).
No evidence of active, uncontrolled infection.
No evidence of clinically significant disseminated intervascular coagulation (DIC)
No clinically significant abnormalities in core vital signs like heart rate, blood pressure or oxygenation which require inpatient evaluation or monitoring.
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).
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.
Both subject and the identified primary caregiver(s) signed informed consent.
In the opinion of the enrolling physician, there are no medical contraindications to outpatient induction and management.
Male subjects, even if surgically sterilized (i.e., status post vasectomy), must agree to one of the followings:
Female subjects must meet one of the followings:
Logistical Inclusion Criteria
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
The enrolling physician must verify and attest that the subject has a primary caregiver meeting all the following criteria:
The nurse teacher must verify that the subject and primary caregiver have completed and adequately understand the study-dictated nurse teacher educational program.
The nurse teacher must verify the subject and primary caregiver have capacity to comply with outpatient management program.
The subject must have reliable, working telephone access.
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: