Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01200355
First received: September 9, 2010
Last updated: April 25, 2016
Last verified: April 2016
  Purpose

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.


Condition Intervention Phase
Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Drug: micafungin
Drug: posaconazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan Kettering Cancer Center:

Primary Outcome Measures:
  • To compare rates of clinical failure between patients who receive posaconazole and those who receive micafungin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare the incidence of possible, probable or proven IFI between patients who receive posaconazole and those who receive micafungin during treatment phase [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare the incidence of possible, probable or proven IFI between patients who receive posaconazole and those who receive micafungin [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare the rates of discontinuation of study medication for any reason between patients who receive posaconazole and those who receive micafungin. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To compare overall survival rates at 6 weeks (12 weeks) from randomization between the two treatment arms. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 117
Study Start Date: September 2010
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Drug: micafungin
Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
Experimental: 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).
Drug: posaconazole
Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200355

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Genovefa Papanicolaou, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01200355     History of Changes
Other Study ID Numbers: 10-038 
Study First Received: September 9, 2010
Last Updated: April 25, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan Kettering Cancer Center:
MICAFUNGIN
POSACONAZOLE
antifungal
prolonged neutropenia
10-038

Additional relevant MeSH terms:
Leukemia
Syndrome
Myelodysplastic Syndromes
Preleukemia
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neutropenia
Mycoses
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Posaconazole
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents

ClinicalTrials.gov processed this record on September 26, 2016