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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

Primary Purpose

Acute Myelogenous Leukemia, Myelodysplastic Syndrome

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

micafungin

posaconazole

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring MICAFUNGIN, POSACONAZOLE, antifungal, prolonged neutropenia, 10-038

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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<500/mm3 [0.5x109/L]) at baseline or likely to develop within 3 to 5 days and lasting for at least 7 days due to:
Intensive induction chemotherapy for new diagnosis of acute myelogenous leukemia, acute lymphocytic leukemia or myelodysplastic syndrome receiving standard anthracycline based chemotherapy
Re-induction of acute myelogenous or lymphocytic leukemia after primary relapse
Myelodysplastic syndromes requiring induction (myelosuppressive) chemotherapy
Female subjects of childbearing potential must have a negative serum pregnancy test as per MSKCC guidelines.
Able to swallow oral medications

Exclusion Criteria:

Subjects with history of presumed or proven invasive fungal infection within 30 days of randomization.
Subjects who are taking the following:

Drugs known to interact with posaconazole and that may lead to life-threatening side effects (terfenadine, cisapride, and ebastine at entry or within 24 hours before entry, or astemizole at entry or within 10 days before entry); b. Drugs known to lower the serum concentration/efficacy of posaconazole: cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, and isoniazid at entry or within 24 hours before entry; c. Subjects who are planned to receive > 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.

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

micafungin

posaconazole

Arm Description

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).

Outcomes

Primary Outcome Measures

Time to Failure

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.

Secondary Outcome Measures

To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin.

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

Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin.

To Compare Overall Survival Rates at 6 Weeks

Full Information

NCT ID

NCT01200355

First Posted

September 9, 2010

Last Updated

April 4, 2018

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Astellas Pharma US, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01200355

Brief Title

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

Official Title

A Randomized Open-Label Trial of 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 9, 2010 (Actual)

Primary Completion Date

April 20, 2017 (Actual)

Study Completion Date

April 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Astellas Pharma US, Inc.

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myelogenous Leukemia, Myelodysplastic Syndrome

Keywords

MICAFUNGIN, POSACONAZOLE, antifungal, prolonged neutropenia, 10-038

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

micafungin

Arm Type

Experimental

Arm Description

Arm Title

posaconazole

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

micafungin

Intervention Description

Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.

Intervention Type

Drug

Intervention Name(s)

posaconazole

Intervention Description

Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.

Primary Outcome Measure Information:

Title

Time to Failure

Description

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.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

To Compare the Number of Days on Study Drug Between Patients Who Receive Posaconazole and Patients Who Receive Micafungin.

Time Frame

2 years

Title

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

Time Frame

2 years

Title

Prophylaxis Failure of Study Medication for Any Reason Between Patients Who Receive Posaconazole and Those Who Receive Micafungin.

Time Frame

2 years

Title

To Compare Overall Survival Rates at 6 Weeks

Time Frame

6 weeks from randomization between the two treatment arms.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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<500/mm3 [0.5x109/L]) at baseline or likely to develop within 3 to 5 days and lasting for at least 7 days due to: Intensive induction chemotherapy for new diagnosis of acute myelogenous leukemia, acute lymphocytic leukemia or myelodysplastic syndrome receiving standard anthracycline based chemotherapy Re-induction of acute myelogenous or lymphocytic leukemia after primary relapse Myelodysplastic syndromes requiring induction (myelosuppressive) chemotherapy Female subjects of childbearing potential must have a negative serum pregnancy test as per MSKCC guidelines. Able to swallow oral medications Exclusion Criteria: Subjects with history of presumed or proven invasive fungal infection within 30 days of randomization. Subjects who are taking the following: Drugs known to interact with posaconazole and that may lead to life-threatening side effects (terfenadine, cisapride, and ebastine at entry or within 24 hours before entry, or astemizole at entry or within 10 days before entry); b. Drugs known to lower the serum concentration/efficacy of posaconazole: cimetidine, rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, and isoniazid at entry or within 24 hours before entry; c. Subjects who are planned to receive > 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Genovefa Papanicolaou, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

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