Summary

for people ages 3 months to 30 years (full criteria)
at San Francisco, California and other locations
study started

Description

Summary

This randomized phase III trial studies caspofungin acetate to see how it works compared to fluconazole in preventing invasive fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy. Caspofungin acetate or fluconazole may help prevent fungal infections caused by chemotherapy. It is not yet known whether fluconazole is more effective than caspofungin acetate in preventing fungal infections in patients with acute myeloid leukemia who are undergoing chemotherapy.

Official Title

A Randomized Open-Label Trial of Caspofungin Versus Fluconazole to Prevent Invasive Fungal Infections in Children Undergoing Chemotherapy for Acute Myeloid Leukemia (AML)

Details

PRIMARY OBJECTIVES:

  1. To determine if prophylaxis with caspofungin (caspofungin acetate) administered during periods of neutropenia following chemotherapy for acute myeloid leukemia (AML) is associated with a lower incidence of proven or probable invasive fungal infections (IFI) compared with fluconazole.

SECONDARY OBJECTIVES:

  1. To determine if prophylaxis with caspofungin will result in a lower incidence of proven or probable cases of invasive aspergillosis (IA) compared with fluconazole. (Clinical) II. To determine if prophylaxis with caspofungin will result in improved survival compared to fluconazole. (Clinical) III. To determine if prophylaxis with caspofungin will result in less empiric antifungal therapy compared to fluconazole. (Clinical) IV. To determine the sensitivity, specificity, and positive and negative predictive value of biweekly galactomannan (GM) and beta-D glucan testing in diagnosing IFI. (Biological) V. To test the association between single nucleotide polymorphisms (SNPs) in genes involved in innate immunity and proven or probable IFI. (Biological) VI. To develop predictive models of IFI using SNP in genes involved in immunity and clinical covariates. (Biological)

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive caspofungin acetate intravenously (IV) over 1 hour once daily (QD) beginning within 24-72 hours following the last dose of chemotherapy for each course and continuing until absolute neutrophil count (ANC) > 100-500/uL following the nadir or the next chemotherapy course begins.

ARM II: Patients receive fluconazole IV over 1-2 hours or orally (PO) QD beginning within 24-72 hours following the last dose of chemotherapy for each course and continuing until ANC > 100-500/uL following the nadir or the next chemotherapy course begins.

In both arms, treatment continues in the absence of invasive fungal infections or disease progression.

After completion of study treatment, patients are followed up periodically.

Keywords

Acute Myeloid Leukemia Adult Acute Megakaryoblastic Leukemia Adult Acute Monoblastic Leukemia Adult Acute Monocytic Leukemia Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With Maturation Adult Acute Myeloid Leukemia With Minimal Differentiation Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11 Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1 Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A Adult Acute Myeloid Leukemia Without Maturation Adult Acute Myelomonocytic Leukemia Adult Erythroleukemia Adult Pure Erythroid Leukemia Alkylating Agent-Related Acute Myeloid Leukemia Childhood Acute Erythroid Leukemia Childhood Acute Megakaryoblastic Leukemia Childhood Acute Monoblastic Leukemia Childhood Acute Monocytic Leukemia Childhood Acute Myeloid Leukemia in Remission Childhood Acute Myeloid Leukemia With Maturation Childhood Acute Myeloid Leukemia With Minimal Differentiation Childhood Acute Myeloid Leukemia Without Maturation Childhood Acute Myelomonocytic Leukemia Fungal Infection Myeloid Neoplasm Neutropenia Recurrent Adult Acute Myeloid Leukemia Recurrent Childhood Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia Untreated Childhood Myeloid Neoplasm Leukemia Infection Communicable Diseases Neoplasms Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Mycoses Leukemia, Monocytic, Acute Invasive Fungal Infections Leukemia, Megakaryoblastic, Acute Leukemia, Erythroblastic, Acute Fluconazole Caspofungin Echinocandins Caspofungin Acetate Laboratory Biomarker Analysis

Eligibility

You can join if…

Open to people ages 3 months to 30 years

  • Patients must have one of the following diagnoses and/or treatment plans:
  • Newly diagnosed de novo AML
  • First or subsequent relapse of AML
  • Secondary AML
  • Treatment with institutional standard AML therapy in those without AML (for example, myelodysplastic syndrome, bone marrow blasts > 5% or biphenotypia)
  • Note: Patients with a history of prolonged antifungal therapy (example, relapsed AML) are eligible
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m2 OR a serum creatinine based on age/gender as follows:

  • =< 0.4 mg/dL (age 1 month to < 6 months)
  • =< 0.5 mg/dL (age 6 months to < 1 year)
  • =< 0.6 mg/dL (age 1 to < 2 years)
  • =< 0.8 mg/dL (age 2 to < 6 years)
  • =< 1 mg/dL (age 6 to < 10 years)
  • =< 1.2 mg/dL (age 10 to < 13 years)
  • =< 1.4 mg/dL (females age >= 13 years)
  • =< 1.5 mg/dL (males age 13 to < 16 years)
  • =< 1.7 mg/dL (males age >= 16 years)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x ULN for age
  • All patients and/or their parents or legal guardians must sign a written informed consent

You CAN'T join if...

  • Patients with the following diagnoses are not eligible:
  • Acute promyelocytic leukemia (APL)
  • Down syndrome
  • Juvenile myelomonocytic leukemia (JMML)
  • Patients with a documented history of invasive fungal infection (IFI) within the previous 30 days are not eligible
  • Patients with a history of echinocandin or fluconazole hypersensitivity are not eligible
  • Patients receiving treatment for an IFI are not eligible
  • Female patients of childbearing age must have a negative pregnancy test
  • Patients must agree to use an effective birth control method
  • Lactating patients must agree not to nurse a child while on this trial

Locations

  • UCSF Medical Center-Parnassus
    San Francisco California 94143 United States
  • UCSF Medical Center-Mission Bay
    San Francisco California 94158 United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Children's Oncology Group
ID
NCT01307579
Phase
Phase 3
Study Type
Interventional
Last Updated