People with acute myeloid leukemia (AML) are usually treated with chemotherapy. When the cancer comes back (relapse) the next treatment is usually a stem cell transplant. Some people with AML have a changed FLT3 gene which causes leukemia cells to grow faster. This means their cancer may come back more quickly after treatment. Gilteritinib is approved in many countries to treat people with AML with the changed FLT3 gene whose cancer has come back or have not responded to previous treatment. In some countries, more studies are needed to approve gilteritinib for use. This study is about people with AML with the changed FLT3 gene. The main aim was to learn if gilteritinib improves how long people stay cancer-free (in remission) after a stem cell transplant. To do this, 2 groups were compared. 1 group were given gilteritinib after a stem cell transplant. This happened in previous studies called the ADMIRAL study and COMMODORE study. The other group received standard of care after their stem cell transplant. They did not receive gilteritinib after their stem cell transplant. In this study, information about the people who received standard of care after their stem cell transplant will be collected. This study is about collecting information only. The study sponsor (Astellas) will not provide any treatment. Information will be collected from the people's medical records between 01 Jan 2015 and 31 Dec 2022. The study doctors will collect information from the first relapse, during and after the stem cell transplant. Then, they will record when any of the following happened after the stem cell transplant: the person passed away, their cancer came back, they decided to leave the study or could not be contacted.
Study Type
OBSERVATIONAL
Enrollment
114
tablet, oral
AU61001
Melbourne, Australia
AU61002
Melbourne, Australia
BR55004
Fortaleza, Brazil
BR55002
Porto Alegre, Brazil
BR55001
São Paulo, Brazil
BR55003
São Paulo, Brazil
CN86003
Shanghai, China
CN86004
Suzhou, China
CN86001
Tianjin, China
HK852001
Hong Kong, Hong Kong
...and 8 more locations
Relapse Free Survival (RFS)
RFS is defined as the time from index date to the date of relapse or the date of death from any cause, whichever comes first.
Time frame: 12 months after index date (90 days post-HSCT)
Overall Survival (OS)
OS is defined as time from the index date until the date of death from any cause.
Time frame: Up to 24 months after index date (90 days post-HSCT)
Graft-versus-host disease (GvHD)-free relapse-free survival (GFS)
GFS is defined as the time from the index date to the date of grades III to IV acute GvHD, chronic GvHD requiring systemic treatment, cytogenetic or hematologic relapse, and death from any cause after HSCT.
Time frame: 12 months after index date (90 days post-HSCT)
Cumulative Incidence of Relapse
Cumulative incidence of relapse is defined as the time from the index date to the date of first relapse, with non-relapse related death (or death in complete remission) being the competing risk.
Time frame: Up to 24 months
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