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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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Acute Myelogenous Leukemia, Myelodysplastic Syndrome

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To compare rates of clinical failure between patients who receive posaconazole and those who receive micafungin.

Outcome 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.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Genovefa Papanicolaou, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

10-038

NCT ID:

NCT01200355

Start Date:

September 2010

Completion Date:

September 2014

Related Keywords:

  • Acute Myelogenous Leukemia
  • Myelodysplastic Syndrome
  • MICAFUNGIN
  • POSACONAZOLE
  • antifungal
  • prolonged neutropenia
  • 10-038
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Mycoses
  • Myelodysplastic Syndromes
  • Preleukemia
  • Neutropenia

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021