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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06734585
Registration number
NCT06734585
Ethics application status
Date submitted
11/12/2024
Date registered
16/12/2024
Date last updated
12/09/2025
Titles & IDs
Public title
Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant
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Scientific title
A Comparison Between Gilteritinib in Phase 3 Trials Versus Real-World External Comparator Cohort of Relapsed/Refractory (R/R) FLT3m+ Acute Myeloid Leukemia (AML) Patients After Hematopoietic Stem Cell Transplantation (HSCT)
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Secondary ID [1]
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2215-MA-3574
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Gilteritinib
External Comparator - Participants with R/R Feline McDonough Sarcoma-like Tyrosine Kinase 3 Mutation (FLT3)+AML who underwent HSCT after achieving any type of complete remission (CR) and who received best supportive care after HSCT.
Gilteritinib - Participants with R/R FLT3+AML who were enrolled in the ADMIRAL and COMMORDORE phase 3 studies that resumed gilteritinib after HSCT to maintain remission.
Treatment: Drugs: Gilteritinib
tablet, oral
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Relapse Free Survival (RFS)
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Assessment method [1]
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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.
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Timepoint [1]
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12 months after index date (90 days post-HSCT)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as time from the index date until the date of death from any cause.
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Timepoint [1]
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Up to 24 months after index date (90 days post-HSCT)
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Secondary outcome [2]
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Graft-versus-host disease (GvHD)-free relapse-free survival (GFS)
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Assessment method [2]
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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.
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Timepoint [2]
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12 months after index date (90 days post-HSCT)
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Secondary outcome [3]
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Cumulative Incidence of Relapse
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 24 months
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Eligibility
Key inclusion criteria
Gilteritinib Group
* Patients from ADMIRAL and COMMODORE phase 3 studies that resumed gilteritinib after HSCT to maintain remission
External Comparator Group
* Patient with a diagnosis of AML according to World Health Organization (WHO) classification
* Patient with positive either FLT3-Internal Tandem Duplications (ITD) or FLT3- Tyrosine Kinase Domain (TKD) genetic testing or re-testing
* Patient with pre-defined first R/R AML at enrollment:
* Refractory to first-line AML therapy is defined as patient not achieving CR/Complete Remission with Incomplete Hematologic Recovery (CRi)/Complete Remission with Incomplete Platelet Recovery (CRp) under initial therapy. A patient eligible for standard therapy must receive at least 1 cycle of an anthracycline containing induction block in standard dose for the selected induction regimen. A patient not eligible for standard therapy must have received at least 1 complete block of induction therapy seen as the optimum choice of therapy to induce remission for this patient.
* Relapsed after first-line AML therapy. First-line AML therapy is defined as (all criteria must be met): Patient achieved a CR/CRi/CRp (as defined by International Working Group criteria) and Initial AML therapy must have consisted of up to 2 induction blocks with or without consolidation or maintenance, with or without transplantation
* Patient underwent allogenic HSCT upon R/R AML diagnosis
* Patient who was alive at 90 days post-HSCT and:
* Patient had successful engraftment as demonstrated by absolute neutrophil count (ANC) = 500/mm3 and platelets = 20000/mm3 without transfusions
* Patient did not have grade 3 or above acute GvHD
* Patient was in any type of CR
* Patient who received best supportive care after HSCT; Best supportive care refers to treatment(s) patients received in CR after HSCT and remained in CR when given the intervention. This may include prophylactic intrathecal chemotherapy, cranial radiation, and donor lymphocyte infusion as part of the HSCT treatment plan.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
External Comparator Group
* Eastern Cooperative Oncology Group (ECOG) = 2
* Patients who received midostaurin, sorafenib, gilteritinib, or venetoclax, or chemotherapy post-HSCT as maintenance therapy prior to index date
* Patient diagnosed with acute promyelocytic leukemia
* Enrollment in drug interventional post-HSCT AML clinical trials during study period
* Critical information is not available for abstraction; Critical information includes FLT3m+confirmation, R/R confirmation, transplantation outcomes (e.g., any type of CR, any grade 3 or above GvHD) at 90 days post-HSCT
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
14/07/2025
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Sample size
Target
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Accrual to date
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Final
114
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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AU61001 - Melbourne
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Recruitment hospital [2]
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AU61002 - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Brazil
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State/province [1]
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Fortaleza
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Country [2]
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Brazil
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State/province [2]
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Porto Alegre
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Country [3]
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Brazil
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State/province [3]
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São Paulo
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Country [4]
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China
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State/province [4]
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Shanghai
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Country [5]
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China
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State/province [5]
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Suzhou
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Country [6]
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China
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State/province [6]
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Tianjin
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Country [7]
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Hong Kong
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State/province [7]
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Hong Kong
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Country [8]
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South Korea
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State/province [8]
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Busan
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Country [9]
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South Korea
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State/province [9]
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Gwangju
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Country [10]
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South Korea
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State/province [10]
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Seoul
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Country [11]
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Taiwan
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State/province [11]
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Taichung
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Country [12]
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Taiwan
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State/province [12]
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Tainan City
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Country [13]
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Taiwan
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State/province [13]
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Astellas Pharma Singapore Pte. Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT06734585
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Central Contact
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Address
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Astellas Pharma Singapore Pte. Ltd.
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06734585
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