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

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ClinicalTrials.gov Identifier: NCT03988205
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : October 18, 2019
Sponsor:
Information provided by (Responsible Party):
Laura Michaelis, Medical College of Wisconsin

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Behavioral: Outpatient Care Model Drug: CPX-351 Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility of Safely Managing Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia (AML) in an Outpatient Environment
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022


Arm Intervention/treatment
Experimental: Intervention
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. Induction therapy and medical follow up are performed without prophylactic admission to an inpatient facility. Subjects will also receive CPX-351 according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
Behavioral: Outpatient Care Model
Outpatient care model includes a nurse teacher educational program, scheduled outpatient visit protocol, and quality of life surveys for both subjects and caregivers.

Drug: CPX-351
CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
Other Names:
  • Cytarbine
  • Vyxeos




Primary Outcome Measures :
  1. Adherence to Recommendations [ Time Frame: Day 60 ]
    This measure will record the number subjects who adhere to outpatient follow-up appointments and readmission recommendations. Subjects completing 95% of their recommended outpatient visits will be considered to be adherent to the recommendations.

  2. Adherence to Readmission Recommendations [ Time Frame: Day 60 ]
    This measure will record the number of subjects who complete as 100% compliance with medical provider recommendations to be admitted to the hospital (except for reasons of adopting a palliative or hospice approach to care). Subjects not achieving a 100% rate of compliance will be considered non-adherent to the recommendations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. ECOG of 0 or 1 (or Karnofsky Performance Status equivalent of 70 or above).
  4. Total bilirubin ≤ 3 mg/dL.
  5. Creatinine clearance > 30mL/min by Cockcroft/Gault equation.
  6. Normal cardiac function, as assessed by ejection fraction via. MUGA or echocardiogram.
  7. Total WBC of ≤ 20,000/uL on peripheral blood assessment.
  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, CBC (complete blood count), CMP (comprehensive metabolic panel), uric acid, and 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988205


Contacts
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Contact: Medical College of Wisconsin Cancer Center Clinical Trials Office 414-805-8900 cccto@mcw.edu

Locations
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United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lauren Michaelis, MD    414-805-4600    lmichaelis@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Laura Michaelis, MD Medical College of Wisconsin

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Responsible Party: Laura Michaelis, Associate Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT03988205     History of Changes
Other Study ID Numbers: PRO34597
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: October 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Laura Michaelis, Medical College of Wisconsin:
Acute Myeloid Leukemia
Outpatient
CPX-351
VYXEOS
Additional relevant MeSH terms:
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Cytarabine
Daunorubicin
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors