Trial Outcomes & Findings for Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia (NCT NCT03988205)
NCT ID: NCT03988205
Last Updated: 2022-07-19
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
3 participants
Primary outcome timeframe
Day 60
Results posted on
2022-07-19
Participant Flow
Participant milestones
| Measure |
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.
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: CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
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|---|---|
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Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
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3
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patients Receiving Induction With Liposomal Daunorubicin and Cytarabine (CPX-351) for Acute Myeloid Leukemia
Baseline characteristics by cohort
| Measure |
Intervention
n=3 Participants
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.
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: CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
|
Age, Continuous
|
63.34 years
STANDARD_DEVIATION .75 • n=99 Participants
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|
Sex: Female, Male
Female
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2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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3 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Day 60This 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.
Outcome measures
| Measure |
Intervention
n=3 Participants
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.
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: CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
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|---|---|
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Number of Participants Adherent to Recommendations
|
3 Participants
|
PRIMARY outcome
Timeframe: Day 60This 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.
Outcome measures
| Measure |
Intervention
n=3 Participants
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.
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: CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
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|---|---|
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Number of Participants Adherent to Readmission Recommendations
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3 Participants
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Adverse Events
Intervention
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=3 participants at risk
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.
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: CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
|
66.7%
2/3 • Number of events 2 • 60 days
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|
General disorders
Fever
|
33.3%
1/3 • Number of events 3 • 60 days
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Other adverse events
| Measure |
Intervention
n=3 participants at risk
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.
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: CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
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|---|---|
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Blood and lymphatic system disorders
Anemia
|
33.3%
1/3 • Number of events 11 • 60 days
|
|
Cardiac disorders
Sinus tachycardia
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33.3%
1/3 • Number of events 1 • 60 days
|
|
Gastrointestinal disorders
Constipation
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33.3%
1/3 • Number of events 2 • 60 days
|
|
Gastrointestinal disorders
Diarrhea
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33.3%
1/3 • Number of events 1 • 60 days
|
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Gastrointestinal disorders
Nausea
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33.3%
1/3 • Number of events 1 • 60 days
|
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General disorders
Edema face
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33.3%
1/3 • Number of events 1 • 60 days
|
|
Infections and infestations
Bacteremia
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Investigations
Alkaline phosphatase increased
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33.3%
1/3 • Number of events 1 • 60 days
|
|
Investigations
Blood bicarbonate decreased
|
33.3%
1/3 • Number of events 3 • 60 days
|
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Investigations
Investigations - Other, specify
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33.3%
1/3 • Number of events 15 • 60 days
|
|
Investigations
Lymphocyte count decreased
|
66.7%
2/3 • Number of events 4 • 60 days
|
|
Investigations
Neutrophil count decreased
|
100.0%
3/3 • Number of events 8 • 60 days
|
|
Investigations
Platelet count decreased
|
100.0%
3/3 • Number of events 32 • 60 days
|
|
Investigations
White blood cell decreased
|
100.0%
3/3 • Number of events 11 • 60 days
|
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Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
1/3 • Number of events 2 • 60 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 4 • 60 days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
33.3%
1/3 • Number of events 8 • 60 days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
33.3%
1/3 • Number of events 3 • 60 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 3 • 60 days
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 2 • 60 days
|
|
Nervous system disorders
Paresthesia
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Psychiatric disorders
Anxiety
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33.3%
1/3 • Number of events 1 • 60 days
|
|
Psychiatric disorders
Insomnia
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33.3%
1/3 • Number of events 1 • 60 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • 60 days
|
|
Vascular disorders
Hypertension
|
33.3%
1/3 • Number of events 1 • 60 days
|
Additional Information
Laura Michaelis, MD
Froedtert and the Medical college of Wisconsin
Phone: 414-805-6700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place