Phase 4
N=113
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
Acute Myelogenous Leukemia · Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01200355 ↗Enrolled (actual)
113
Serious AEs
29.2%
Results posted
Jul 2017
Primary outcome: Primary: Time to Failure — 16; 13 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- micafungin (Drug); posaconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Failure |
16; 13 | — |
| SECONDARY To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin. |
11; 12 | — |
| SECONDARY 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; 3 | — |
| SECONDARY Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin. |
20; 29; 38; 26 | — |
| SECONDARY To Compare Overall Survival Rates at 6 Weeks |
7; 2 | — |
Summary
The purpose of this study is to compare the effects, good and/or bad, of posaconazole and micafungin in preventing fungal infections after chemotherapy for acute leukemia or myelodysplastic syndrome. When people take chemotherapy, they are more likely to get infections. Posaconazole has been approved for the prevention of fungal infections in patients who receive induction chemotherapy for acute leukemia and myelodysplastic syndrome. Posaconazole is available only as an oral suspension and has to be given with food. After chemotherapy, many patients are not able to tolerate food or oral medication because of severe mucositis. Patients unable to tolerate food and oral medications cannot take posaconazole.
Micafungin is an antifungal medication that is given only intravenously. Micafungin is approved for the treatment of certain fungal infections and for preventing fungal infections in patients who receive bone marrow transplant. The investigators know that micafungin is safe. Micafungin has not been tested for the prevention of fungal infections in patients receiving chemotherapy for acute leukemia and myelodysplastic syndrome. Because micafungin is given by vein, it can be given even in patients who cannot take food or medications by mouth after chemotherapy. In this study the investigators want to compare micafungin to posaconazole when given for the prevention of fungal infections in leukemia and myelodysplastic syndrome patients.
Eligibility Criteria
Inclusion Criteria
- Subjects of greater than or equal to 18 years of age of either sex and of any race.
Disease definition:
- Anticipated or documented prolonged neutropenia (ANC 2mg flat dose of vinca alkaloids.
- Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents.
- Subjects with renal insufficiency (estimated creatinine clearance less than 20 mL/minute at baseline or likely to require dialysis during the study).
- Subjects having an electrocardiogram with a prolonged QTc interval by manual reading: QTc greater than 490 msec.
- Subjects with moderate or severe liver dysfunction at baseline, defined as aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than 5 times the upper limit of normal (ULN), or a total bilirubin level greater than 3 times the ULN.
- Subjects who are undergoing re-induction chemotherapy and have participated in this study during their first induction chemotherapy.
- Subjects who will be receiving dasatinib.
Data sourced from ClinicalTrials.gov (NCT01200355). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.