Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    120
  • sponsor
    Medical College of Wisconsin
Updated on 3 June 2021
myelodysplasia
cytarabine
ejection fraction
daunorubicin
cytarabine/daunorubicin
leukapheresis
hydrea

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.

Description

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.

Details
Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment CPX-351, Outpatient Care Model
Clinical Study IdentifierNCT03988205
SponsorMedical College of Wisconsin
Last Modified on3 June 2021

Eligibility

Yes No Not Sure

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/L 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
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
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
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
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

Pregnant women (per pregnancy test in women of childbearing potential) or women who are breast-feeding
Subjects currently receiving any investigational agents
Subjects must not have current evidence of another malignancy that requires treatment
Subjects diagnosed with Wilson's disease and/or copper-related metabolic disorders
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