Trial Outcomes & Findings for Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome (NCT NCT01200355)
NCT ID: NCT01200355
Last Updated: 2018-05-07
Results Overview
Clinical failure is defined as: 1) need for systemic antifungal therapy (AmBisome) for \> 3 consecutive days for presumptive fungal infection, toxicity or intolerance of study medication or 2) death.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
113 participants
Primary outcome timeframe
2 years
Results posted on
2018-05-07
Participant Flow
Protocol Open to Accrual 09/09/2010 Protocol Closed to Accrual 04/20/2016 Primary Completion Date 04/20/2016 Recruitment Location is the medical clinic
Participant milestones
| Measure |
Micafungin
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
55
|
|
Overall Study
COMPLETED
|
51
|
53
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
Micafungin
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
|---|---|---|
|
Overall Study
Death
|
7
|
2
|
Baseline Characteristics
Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Micafungin
n=58 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
n=55 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Total
n=113 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
59 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
58 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Analysis based on a modified intention-to-treat (mITT) approach, with the use of data from patients who underwent randomization and received 2 or more doses of prophylaxis. Trial designed w/ power to detect absolute differences of \~25% of prophylaxis failure in the two groups with \~ 80% power and a significance level of 5% using a two-tail test.
Clinical failure is defined as: 1) need for systemic antifungal therapy (AmBisome) for \> 3 consecutive days for presumptive fungal infection, toxicity or intolerance of study medication or 2) death.
Outcome measures
| Measure |
Micafungin
n=58 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
n=55 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
|---|---|---|
|
Time to Failure
|
16 Days
Interval 12.0 to 20.0
|
13 Days
Interval 6.0 to 16.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Results reflect patients who discontinued prophylaxis for suspected IFI (invasive fungal infection)
Outcome measures
| Measure |
Micafungin
n=58 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
n=55 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
|---|---|---|
|
To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin.
|
11 days
Interval 8.0 to 16.0
|
12 days
Interval 9.0 to 14.0
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Micafungin
n=58 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
n=55 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
|---|---|---|
|
To Compare the Incidence of Possible, Probable or Proven Invasive Fungal Infections Between Patients Who Receive Posaconazole and Those Who Receive Micafungin During Treatment Phase
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Micafungin
n=58 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
n=55 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
|---|---|---|
|
Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin.
No prophylaxis failure
|
38 Participants
|
26 Participants
|
|
Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin.
Prophylaxis failure
|
20 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6 weeks from randomization between the two treatment arms.Outcome measures
| Measure |
Micafungin
n=58 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
n=55 Participants
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
|---|---|---|
|
To Compare Overall Survival Rates at 6 Weeks
|
7 Participants
|
2 Participants
|
Adverse Events
Micafungin
Serious events: 22 serious events
Other events: 0 other events
Deaths: 7 deaths
Posaconazole
Serious events: 11 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Micafungin
n=58 participants at risk
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
micafungin: Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
Posaconazole
n=55 participants at risk
This is a single institution (MSKCC), randomized, open-label comparative trial of micafungin and posaconazole administered as prophylaxis against fungal infections during neutropenia following induction chemotherapy for myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), myelodysplastic syndrome (MDS).
posaconazole: Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
|
|---|---|---|
|
Investigations
Bilirubin Increased
|
1.7%
1/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.7%
1/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.9%
4/58 • 2 years
|
5.5%
3/55 • 2 years
|
|
General disorders
Fever
|
3.4%
2/58 • 2 years
|
3.6%
2/55 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
3.4%
2/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Immune system disorders
Immune system disorders - Other, specify
|
1.7%
1/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
10.3%
6/58 • 2 years
|
3.6%
2/55 • 2 years
|
|
General disorders
Multi-organ failure
|
1.7%
1/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Gastrointestinal disorders
Oral Pain
|
3.4%
2/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.7%
1/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Infections and infestations
Sepsis
|
5.2%
3/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
1.7%
1/58 • 2 years
|
0.00%
0/55 • 2 years
|
|
Infections and infestations
Upper respiratory infection
|
5.2%
3/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/58 • 2 years
|
7.3%
4/55 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, spec
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
|
General disorders
Death NOS
|
0.00%
0/58 • 2 years
|
1.8%
1/55 • 2 years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Genovefa Papanicolaou MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-8361
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place