Acute Myeloid LeukemiaNCT06734585
Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant
An observational study of Acute Myeloid Leukemia, run by Astellas Pharma Singapore Pte. Ltd. at 18 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Gilteritinib
- Type of treatment
- Pill or oral medicine
- How many people
- 114 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 9 Jan 2025to 14 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The external comparator group will include participants with R/R FLT3+AML who underwent HSCT after achieving any type of CR and who received best supportive care after HSCT. Data for the gilteritinib group will be obtained from a subgroup of ADMIRAL and COMMODORE phase 3 studies that resumed gilteritinib after HSCT to maintain remission.
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
South Korea5 sites
KR82004
Busan
KR82005
Gwangju
KR82001
Seoul
KR82002
Seoul
KR82003
Seoul
Brazil4 sites
BR55004
Fortaleza
BR55002
Porto Alegre
BR55001
São Paulo
BR55003
São Paulo
About this study
Official 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)
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.
Read more
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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Gilteritinib
- Keywords
- Gilteritinib, Xospata, Relapsed or refractory FLT3m+ Acute Myeloid Leukemia (AML), Hematopoietic Stem Cell Transplantation (HSCT), Best Supportive Care
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GilteritinibDrug
Also called ASP2215, XOSPATA®
tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gilteritinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after index date (90 days post-HSCT)
Secondary outcomes (3)
Overall Survival (OS)
OS is defined as time from the index date until the date of death from any cause.
Measured: 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.
Measured: 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.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start9 Jan 2025
- Primary completion14 Jul 2025
- Study completion14 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Central Contact, Study director, Astellas Pharma Singapore Pte. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734585
- Sponsor's protocol ID
- 2215-MA-3574
- Status last verified
- Sep 2025
- First submitted
- 11 Dec 2024
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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/.
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT06734585
- Acronym / sponsor ID
- 2215-MA-3574
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Gilteritinib, Xospata, Relapsed or refractory FLT3m+ Acute Myeloid Leukemia (AML), Hematopoietic Stem Cell Transplantation (HSCT), Best Supportive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Astellas Pharma Singapore Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 14 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: GilteritinibParticipants with R/R FLT3+AML who were enrolled in the ADMIRAL and COMMORDORE phase 3 studies that resumed gilteritinib after HSCT to maintain remission. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The external comparator group will include participants with R/R FLT3+AML who underwent HSCT after achieving any type of CR and who received best supportive care after HSCT. Data for the gilteritinib group will be obtained from a subgroup of ADMIRAL and COMMODORE phase 3 studies that resumed gilteritinib after HSCT to maintain remission.
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GilteritinibAlso: ASP2215, XOSPATA®tablet, oral | Drug | Gilteritinib |
Primary outcome
Relapse Free Survival (RFS)
Time frame: 12 months after index date (90 days post-HSCT)
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.
3 secondary outcomes
Overall Survival (OS)
Time frame: Up to 24 months after index date (90 days post-HSCT)
Graft-versus-host disease (GvHD)-free relapse-free survival (GFS)
Time frame: 12 months after index date (90 days post-HSCT)
Cumulative Incidence of Relapse
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Central Contact study director
Astellas Pharma Singapore Pte. Ltd.
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, run by Astellas Pharma Singapore Pte. Ltd. at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea, Brazil, China, Taiwan, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Free Survival (RFS) (time frame: 12 months after index date (90 days post-HSCT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.