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Trial Outcomes & Findings for Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia (NCT NCT02440178)

NCT ID: NCT02440178

Last Updated: 2021-11-09

Results Overview

proven fungal infection: proven by positive culture for fungus with symptoms and signs of a fungal infection probable fungal infection: direct or indirect detection (galactomannan antigen or serum β-D-glucan) with clinical and radiographic findings possible fungal infection: sufficient clinical evidence for fungal infection was present without mycological evidence

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

66 participants

Primary outcome timeframe

the day of 6 weeks after induction chemotherapy

Results posted on

2021-11-09

Participant Flow

Participant milestones

Participant milestones
Measure
Micafungin Prophylaxis
50 mg micafungin intravenously once daily from the initiation of induction chemotherapy to recovery of neutrophil count (absolute neutrophil count \> 500/μg for three consecutive days), suspected fungal infection, or occurrence of drug-related toxicity
Overall Study
STARTED
66
Overall Study
COMPLETED
46
Overall Study
NOT COMPLETED
20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Micafungin Prophylaxis
n=65 Participants
The baseline characteristics of total patients
Age, Categorical
<=18 years
1 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
57 Participants
n=5 Participants
Age, Categorical
>=65 years
7 Participants
n=5 Participants
Age, Continuous
51 years
n=5 Participants
Sex: Female, Male
Female
31 Participants
n=5 Participants
Sex: Female, Male
Male
34 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
65 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
0 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
South Korea
65 participants
n=5 Participants

PRIMARY outcome

Timeframe: the day of 6 weeks after induction chemotherapy

proven fungal infection: proven by positive culture for fungus with symptoms and signs of a fungal infection probable fungal infection: direct or indirect detection (galactomannan antigen or serum β-D-glucan) with clinical and radiographic findings possible fungal infection: sufficient clinical evidence for fungal infection was present without mycological evidence

Outcome measures

Outcome measures
Measure
Micafungin Prophylaxis
n=65 Participants
The outcomes of fungal infections
Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
Proven fungal infection
1 Participants
Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
Probable fungal infection
0 Participants
Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
Possible fungal infection
2 Participants
Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
Non fungal infection
62 Participants

SECONDARY outcome

Timeframe: the day of 12 weeks after induction chemotherapy

The survival of patients till 12 weeks after induction chemotherapy

Outcome measures

Outcome measures
Measure
Micafungin Prophylaxis
n=65 Participants
The outcomes of fungal infections
Overall Survival
survival
62 Participants
Overall Survival
death
3 Participants

SECONDARY outcome

Timeframe: The day of 12 weeks after induction chemotherapy

The outcomes of non-relapse mortality: The incidence of death without a previous relapse or progression

Outcome measures

Outcome measures
Measure
Micafungin Prophylaxis
n=65 Participants
The outcomes of fungal infections
Non-relapse Mortality
Non-relapse mortality
3 Participants
Non-relapse Mortality
survival
62 Participants

Adverse Events

Adverse Events

Serious events: 0 serious events
Other events: 3 other events
Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Adverse Events
n=65 participants at risk
Serious adverse events: life-threatening adverse events Other adverse events: non-serious adverse events during treatment
Hepatobiliary disorders
Liver function test abnormality
4.6%
3/65 • 1 year

Additional Information

Pf. Youngil Koh

seoul national university

Phone: 82-2-2072-7217

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place