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← Myeloid Neoplasm

NCT01307579 · STUDY IN CONTEXT

Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · NOT_POSTED

Sensitivity for the diagnosis of proven or probable IFI will be determined for the fungal biomarkers galactomannan and beta-D glucan assays. Sensitivity will be estimated for the combination of the two fungal biomarkers.

Source null

→

exploratory · NOT_POSTED

Specificity of galactomannan and beta-D glucan assays for the diagnosis of proven or probable IFI. Specificity will be estimated for the two fungal biomarkers together.

Source null

→

primary · POSTED

Proven or probable IFI is defined according to criteria developed by the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG).

Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)

→

secondary · POSTED

Proven or probable invasive aspergillosis (IA) is defined according to the criteria developed by the EORTC/MSG. Kaplan Meier approach will used to estimate the incidence.

Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)

→

secondary · POSTED

Kaplan Meier method will be used to estimate overall survival. Time to event is from enrollment to date of death (by any cause). Participants are censored at last contact or 2 years anniversary of enrollment into this study, whichever occurred first.

Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)

→

secondary · POSTED

The percentage of participants requiring empiric antifungal therapy will be determined based on the presence of prolonged fever and neutropenia during each neutropenia course.

Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

EORTC QLQ · Percentage of Participants With Proven or Probable Invasive Fungal Infections (IFI)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01307579
qol key
qol-0000
source section id
NCT01307579-om-0000
source outcome index
0
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Percentage of Participants With Proven or Probable Invasive Fungal Infections (IFI)
measure definition
Proven or probable IFI is defined according to criteria developed by the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG).
time frame
Up to 5 months since enrollment
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Percentage of Participants With Proven or Probable Invasive Aspergillosis (IA)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01307579
qol key
qol-0001
source section id
NCT01307579-om-0001
source outcome index
1
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Percentage of Participants With Proven or Probable Invasive Aspergillosis (IA)
measure definition
Proven or probable invasive aspergillosis (IA) is defined according to the criteria developed by the EORTC/MSG. Kaplan Meier approach will used to estimate the incidence.
time frame
Up to 5 months since enrollment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-myeloid-neoplasm
nct id
NCT01307579
trial label
Caspofungin Versus Fluconazole in Preventing Invasive Fungal Infections (IFI) in Patients Undergoing Chemotherapy for Acute Myeloid Leukemia
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0004
    source section id
    NCT01307579-om-0004
    source outcome index
    4
    endpoint
    Sensitivity of Galactomannan and Beta-D Glucan Assays for the Diagnosis of Proven or Probable IFI
    endpoint definition
    Sensitivity for the diagnosis of proven or probable IFI will be determined for the fungal biomarkers galactomannan and beta-D glucan assays. Sensitivity will be estimated for the combination of the two fungal biomarkers.
    time origin
    Up to 5 months since enrollment
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0005
    source section id
    NCT01307579-om-0005
    source outcome index
    5
    endpoint
    Specificity of Galactomannan and Beta-D Glucan Assays for the Diagnosis of Proven or Probable IFI
    endpoint definition
    Specificity of galactomannan and beta-D glucan assays for the diagnosis of proven or probable IFI. Specificity will be estimated for the two fungal biomarkers together.
    time origin
    Up to 5 months since enrollment
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0000
    source section id
    NCT01307579-om-0000
    source outcome index
    0
    endpoint
    Percentage of Participants With Proven or Probable Invasive Fungal Infections (IFI)
    endpoint definition
    Proven or probable IFI is defined according to criteria developed by the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG).
    time origin
    Up to 5 months since enrollment
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0001
    source section id
    NCT01307579-om-0001
    source outcome index
    1
    endpoint
    Percentage of Participants With Proven or Probable Invasive Aspergillosis (IA)
    endpoint definition
    Proven or probable invasive aspergillosis (IA) is defined according to the criteria developed by the EORTC/MSG. Kaplan Meier approach will used to estimate the incidence.
    time origin
    Up to 5 months since enrollment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0002
    source section id
    NCT01307579-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Kaplan Meier method will be used to estimate overall survival. Time to event is from enrollment to date of death (by any cause). Participants are censored at last contact or 2 years anniversary of enrollment into this study, whichever occurred first.
    time origin
    Up to 2 years post enrollment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0003
    source section id
    NCT01307579-om-0003
    source outcome index
    3
    endpoint
    Percentage of Participants That Need Empiric Antifungal Therapy
    endpoint definition
    The percentage of participants requiring empiric antifungal therapy will be determined based on the presence of prolonged fever and neutropenia during each neutropenia course.
    time origin
    Up to 5 months since enrollment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (Caspofungin Acetate)
    regimen
    Patients receive caspofungin acetate IV over one hour 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. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    253
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01307579-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (Fluconazole)
    regimen
    Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    255
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01307579-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (Caspofungin Acetate)
    regimen
    Patients receive caspofungin acetate IV over one hour 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. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    253
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01307579-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (Fluconazole)
    regimen
    Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    255
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01307579-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (Caspofungin Acetate)
    regimen
    Patients receive caspofungin acetate IV over one hour 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. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    253
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01307579-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (Fluconazole)
    regimen
    Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    255
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01307579-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I (Caspofungin Acetate)
    regimen
    Patients receive caspofungin acetate IV over one hour 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. Caspofungin Acetate: Given IV Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    253
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01307579-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm II (Fluconazole)
    regimen
    Patients receive fluconazole IV over 1-2 hours or PO QD beginning within 24-72 hours following the last dose of chemotherapy for each course. Fluconazole: Given IV or PO Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    255
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01307579-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    harm key
    EG000
    source section id
    NCT01307579-ae
    event group key
    EG000
    event group label
    Arm I (Caspofungin Acetate)
    serious affected
    11
    serious at risk
    253
    other affected
    62
    other at risk
    253
    frequency threshold
    0
    collection period
    Up to 12 months of receiving protocol treatment
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    harm key
    EG001
    source section id
    NCT01307579-ae
    event group key
    EG001
    event group label
    Arm II (Fluconazole)
    serious affected
    9
    serious at risk
    255
    other affected
    72
    other at risk
    255
    frequency threshold
    0
    collection period
    Up to 12 months of receiving protocol treatment
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    qol key
    qol-0000
    source section id
    NCT01307579-om-0000
    source outcome index
    0
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Percentage of Participants With Proven or Probable Invasive Fungal Infections (IFI)
    measure definition
    Proven or probable IFI is defined according to criteria developed by the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG).
    time frame
    Up to 5 months since enrollment
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-myeloid-neoplasm
    nct id
    NCT01307579
    qol key
    qol-0001
    source section id
    NCT01307579-om-0001
    source outcome index
    1
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Percentage of Participants With Proven or Probable Invasive Aspergillosis (IA)
    measure definition
    Proven or probable invasive aspergillosis (IA) is defined according to the criteria developed by the EORTC/MSG. Kaplan Meier approach will used to estimate the incidence.
    time frame
    Up to 5 months since enrollment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Evaluable patients (ineligible and inevaluable due to having IFI before IFI monitoring period were excluded)
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice