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

NCT03988205 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: PRO34597
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Myeloid, Acute

Keywords

Acute Myeloid Leukemia; Outpatient; CPX-351; Vyxeos®; Leukemia

Outcome Measures

Primary Outcomes (2)

• Number of Participants Adherent to Recommendations

  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.

  Day 60

• Number of Participants Adherent to Readmission Recommendations

  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.

  Day 60

Study Arms (1)

Intervention

EXPERIMENTAL

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; Drug: CPX-351

Interventions

Outpatient Care Model BEHAVIORAL

Outpatient care model includes a nurse teacher educational program, scheduled outpatient visit protocol, and quality of life surveys for both subjects and caregivers.

Intervention

CPX-351 DRUG

CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.

Also known as: Cytarabine, Vyxeos®

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia

Interventions

CPX-351; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Laura Michaelis, MD
• Organization: Froedtert and the Medical college of Wisconsin

lmichaelis@mcw.edu

414-805-6700

Study Officials

• Laura Michaelis, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: August 28, 2019
• Primary Completion: December 1, 2021
• Study Completion: April 1, 2022
• Last Updated: July 19, 2022
• Results First Posted: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)