Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03988205|
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : October 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Behavioral: Outpatient Care Model Drug: CPX-351||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
- 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.
- 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.
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
|Contact: Medical College of Wisconsin Cancer Center Clinical Trials Officefirstname.lastname@example.org|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Lauren Michaelis, MD 414-805-4600 email@example.com|
|Principal Investigator:||Laura Michaelis, MD||Medical College of Wisconsin|