Leukemia, Mycoses
Conditions
Keywords
hematological malignancy, fungal infection, leukemia
Brief summary
This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.
Interventions
OTHERStandard Care
Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* To be eligible for study inclusion, the participant must have: * A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant
Exclusion criteria
* The participant is not eligible for study inclusion if: * Their IFI is not related to hematological malignancies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution | 365 days | Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Specific Fungal Pathogen at a Single Institution | 365 days | Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen. |
| Percentage of Participants With Invasive Fungal Infections in Canada | 365 days | Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections. |
Participant flow
Recruitment details
Participants with hematologic malignancy requiring high dose chemotherapy with or without stem cell transplant were selected from a single tertiary care center in Canada.
Participants by arm
| Arm | Count |
|---|---|
| Participants at High Risk for IFI Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation. | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 47 |
| Overall Study | Lost to Follow-up | 5 |
Baseline characteristics
| Characteristic | Participants at High Risk for IFI |
|---|---|
| Age, Continuous | 55.28 Years STANDARD_DEVIATION 15.26 |
| Sex: Female, Male Female | 51 Participants |
| Sex: Female, Male Male | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution
Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.
Time frame: 365 days
Population: All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants at High Risk for IFI | Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution | 32.3 Percentage of participants |
Secondary
Percentage of Participants With a Specific Fungal Pathogen at a Single Institution
Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.
Time frame: 365 days
Population: All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Participants at High Risk for IFI | Percentage of Participants With a Specific Fungal Pathogen at a Single Institution | Aspergillus | 8.5 Percentage of participants |
| Participants at High Risk for IFI | Percentage of Participants With a Specific Fungal Pathogen at a Single Institution | Fusarium | 1.5 Percentage of participants |
| Participants at High Risk for IFI | Percentage of Participants With a Specific Fungal Pathogen at a Single Institution | Penicillium | 0.8 Percentage of participants |
| Participants at High Risk for IFI | Percentage of Participants With a Specific Fungal Pathogen at a Single Institution | Missing | 21.5 Percentage of participants |
Secondary
Percentage of Participants With Invasive Fungal Infections in Canada
Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.
Time frame: 365 days
Population: Whereas enrollment at 5-9 centers in Canada was planned, this was not accomplished, as data were only collected from a single institution in Canada.