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

NCT03988205 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-07-19

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Laura Michaelis, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-28
Primary Completion
2021-12-01
Completion
2022-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988205 on ClinicalTrials.gov