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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02440178
• Collaborator: Astellas Pharma Inc (Industry)
• Enrollment: 66
• Arm: 1
• Actual Duration (Months): 20.4

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether prophylaxis with micafungin is effective in the induction chemotherapy for newly diagnosed acute leukemia patients.

Condition or Disease	Intervention/Treatment	Phase
Acute Leukemia	Drug: Micafungin	Phase 2

Detailed Description

Medically fit patients with newly diagnosed acute leukemia received 50 mg micafungin intravenously once daily from the initiation of first induction chemotherapy to recovery of neutrophil count, suspected fungal infection, or unacceptable drug-related toxicity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Phase II Trial of Micafungin Prophylaxis During Induction Chemotherapy for Patients With Acute Leukemia
• Actual Study Start Date: Sep 19, 2015
• Actual Primary Completion Date: Jun 1, 2017
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: micafungin prophylaxis Patients received 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.	Drug: Micafungin; Other Names: mycamine

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Proven/Probable/Possible Invasive Fungal Infection [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

Secondary Outcome Measures

1. Overall Survival [the day of 12 weeks after induction chemotherapy]

   The survival of patients till 12 weeks after induction chemotherapy

2. Non-relapse Mortality [The day of 12 weeks after induction chemotherapy]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. patients belong to either A-1 or A-2 A-1. patients with newly diagnosed acute myeloid leukemia who approve to get induction chemotherapy with (cytarabine plus idarubicin) or (modified Fludarabine + cytarabine + idarubicin ) A-2. patients with newly diagnosed acute lymphoid leukemia who approve to get induction chemotherapy with VPDL (vincristine + prednisolone + daunorubicin + L-asparaginase), C-VPDL (cyclophosphamide + vincristine + prednisolone + daunorubicin + L-asparaginase), or (R)-hyperCVAD ((Rituximab) + cyclophosphamide + vincristine + Adriamycin + dexamethasone) B. Eastern Cooperative Oncology Group performance status score is equal to or more than 2 C. patients who voluntarily sign the agreement

Exclusion Criteria:

1. evidence of proven/probable/possible fungal infection within 30 days before induction chemotherapy B. hypersensitivity to echinocandin C. patients had other malignancy within 5 years D. previous treatment history with chemotherapy, radiation therapy, or immunosuppressive therapy.

2. pregnant or breast-feeding women F. immunodeficient patients including AIDS G. patients with uncontrolled seizure or psychiatric disorder H. clinically significant heart disorder (myocardial infarction within 3 months or left ventricular ejection fraction < 40%) I. interstitial lung disease J. previous organ transplantation history K. galactose intolerance L. patients who participated this study before.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Seoul National University Hospital
• Astellas Pharma Inc

Investigators

• Principal Investigator: Youngil Koh, Dr., Seoul National University Hospital

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Oct 10, 2021

More Information

Publications

None provided.

• Responsible Party: Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02440178
• Other Study ID Numbers: SNUH-micafungin
• First Posted: May 12, 2015
• Last Update Posted: Nov 9, 2021
• Last Verified: Oct 1, 2017

• Keywords provided by Seoul National University Hospital: leukemia; induction; prophylaxis; antifungal; micafungin; phase II
• Additional relevant MeSH terms: Leukemia; Acute Disease; Micafungin

Study Results

Participant Flow

Arm/Group Title	Micafungin Prophylaxis
Arm/Group Description	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
Period Title: Overall Study
STARTED	66
COMPLETED	46
NOT COMPLETED	20

Baseline Characteristics

Arm/Group Title	Micafungin Prophylaxis
Arm/Group Description	The baseline characteristics of total patients
Overall Participants	65
Age (Count of Participants)
<=18 years	1 1.5%
Between 18 and 65 years	57 87.7%
>=65 years	7 10.8%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	51
Sex: Female, Male (Count of Participants)
Female	31 47.7%
Male	34 52.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	65 100%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
South Korea	65 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Proven/Probable/Possible Invasive Fungal Infection
Description	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
Time Frame	the day of 6 weeks after induction chemotherapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Micafungin Prophylaxis
Arm/Group Description	The outcomes of fungal infections
Measure Participants	65
Proven fungal infection	1 1.5%
Probable fungal infection	0 0%
Possible fungal infection	2 3.1%
Non fungal infection	62 95.4%

2. Secondary Outcome

Title	Overall Survival
Description	The survival of patients till 12 weeks after induction chemotherapy
Time Frame	the day of 12 weeks after induction chemotherapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Survival Outcome
Arm/Group Description	The survival of patients till 12 weeks after induction chemotherapy
Measure Participants	65
survival	62 95.4%
death	3 4.6%

3. Secondary Outcome

Title	Non-relapse Mortality
Description	The outcomes of non-relapse mortality: The incidence of death without a previous relapse or progression
Time Frame	The day of 12 weeks after induction chemotherapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-relapse Mortality
Arm/Group Description	Non-relapse mortality was defined as the incidence of death without a previous relapse or progression.
Measure Participants	65
Non-relapse mortality	3 4.6%
survival	62 95.4%

Adverse Events

Time Frame	1 year
Arm/Group Title	Adverse Events
Arm/Group Description	Serious adverse events: life-threatening adverse events Other adverse events: non-serious adverse events during treatment
All Cause Mortality
	Adverse Events
	Affected / at Risk (%)	# Events
Total	3/65 (4.6%)
Serious Adverse Events
	Adverse Events
	Affected / at Risk (%)	# Events
Total	0/65 (0%)
Other (Not Including Serious) Adverse Events
	Adverse Events
	Affected / at Risk (%)	# Events
Total	3/65 (4.6%)
Hepatobiliary disorders
Liver function test abnormality	3/65 (4.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.