NCT03988205

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

The Feasibility of Safely Managing Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia (AML) in an Outpatient Environment

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Leukemia, Myeloid, Acute

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-28
• Primary completion: 2021-12-01
• Completion: 2022-04-01
• First posted: 2019-06-17
• Last updated: 2022-07-19
• Results posted: 2022-07-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study