FLT3 Gene MutationPhase 1/2FLT3AML-2024NCT06561880
The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation
A Phase 1/2 study testing Venetoclax, Cytarabine and Gilteritinib in people with FLT3 Gene Mutation and AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- FLT3 Gene Mutation, AML
- What is being tested?
- Venetoclax, Cytarabine and Gilteritinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2024to 31 Aug 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.
- Age ≥15 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Pass the requirements of the following laboratory tests (performed within 7 days before treatment) :
- 1) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times the upper limit of normal value (same age); 3) Blood creatinine < 2 times the upper limit of normal (same age); 4) Myocardial enzymes < 2 times the upper limit of normal (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range.
Who cannot join
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy).
- Concurrent malignant tumors of other organs (those requiring treatment).
- Active heart disease, defined as one or more of the following:
- 1) A history of uncontrolled or symptomatic angina; 2) Myocardial infarction less than 6 months after enrollment; 3) Have a history of arrhythmia requiring drug treatment or severe clinical symptoms; 4) Uncontrolled or symptomatic congestive heart failure (> NYHA level 2); 5) The ejection fraction is lower than the lower limit of the normal range. 7. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis). 8. Those who were not considered suitable for inclusion by the researchers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
hui wei, MD, 86-13132507161, weihui@ihcams.ac.cn
About this study
Official title: The Efficacy of a Triple Regimen Including Gilteritinib, Venetoclax, and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation
The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.
Read the detailed description
This stuay intends to conduct a clinical study to explore the efficacy and safety of the triple induction regimen consisting of Gilteritinib, Venetoclax, and Azacitidine in newly diagnosed FLT3 mutated AML patients who are suitable for intensive chemotherapy. Patients will receive 2 courses of triple regimen therapy for induction and those who achieved complete remission will receive 3 courses of intermediate-dose cytarabine for consolidation. After consolidation therapy, dose-adjusted triple regimen therapy will be applied for 6 courses as maintenance treatment. Bone marrow morphology and minimal residual disease detected by flow cytometry and next-generation sequencing will be monitored during the treatment to provide evidence for treatment decisions. Response and survival of patients will be recorded to evaluate the efficacy of the triple regimen.
- Conditions
- FLT3 Gene Mutation, AML
- Being tested
- Venetoclax, Cytarabine, Gilteritinib, Azacitadine (AZA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenetoclaxDrug
Venetoclax dose and schedule determined by arms and treatment phases
CytarabineDrug
Also called Gilteritinib
Consolidation therapy (3 courses):
intermediate-dose cytarabine regimen :2g/m2 q12h d1-3, age < 60 years;1g/m2 q12h d1-3, age ≥60 years.
If NGS detected FLT3 mutation before consolidation chemotherapy, gilteritinib will be added during the consolidation course at d4-17.
GilteritinibDrug
Gilteritinib 120mg schedule determined by arms or treatment phases
Azacitadine (AZA)Drug
Azacitidine 75mg/m2/d schedule determined by treatment phases
| Study group | Role | What they receive |
|---|---|---|
| Triple Regimen Induction of Arm1 | Experimental | Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-14; Venetoclax: 100mg d1, 200mg d2, 400mg d3-14 Receives: Drug: Venetoclax; Drug: Cytarabine; Drug: Gilteritinib; Drug: Azacitadine (AZA) |
| Triple Regimen Induction of Arm2 | Experimental | Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-14; Venetoclax: 100mg d1, 200mg d2, 400mg d3-7 Receives: Drug: Venetoclax; Drug: Cytarabine; Drug: Gilteritinib; Drug: Azacitadine (AZA) |
| Triple Regimen Induction of Arm3 | Experimental | Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-7; Venetoclax: 100mg d1, 200mg d2, 400mg d3-7 Receives: Drug: Venetoclax; Drug: Cytarabine; Drug: Gilteritinib; Drug: Azacitadine (AZA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete remission (CRc) rate
The ratio of patients achieved CRc（CR/CRh/CRi) after induction therapy
Measured: up to 3 months after the date of the last enrolled participants
Composite Complete remission (CRc) with negative MRD detected by flow cytometry.
The ratio of CRc with negative MRD detected by flow cytometry after induction, consolidation, and maintenance therapy.
Measured: up to 1 years after the date of the last enrolled participants
To determine the tolerated dose of triple regimens
The dose of gilteritinib and venetoclax that can be safely combined with azacitidine
Measured: up to 3 months after enrollment of the first participants
Event-free survival (EFS)
The interval from the date of enrollment to the date of failed to achieve complete remission, the date of relapse, or the date of death, whichever occurred first.
Measured: up to 2 years after the date of the last enrolled participants
Secondary outcomes (5)
CRc with negative MRD detected by NGS (next-generation sequencing)
The ratio of CRc with negative MRD detected by NGS after induction,consolidation, and maintenance therapy
Measured: up to 1 years after the date of the last enrolled participants
overall survival
The interval from the date of enrollment to the date of death or the date of last follow-up, , whichever occurred first.
Measured: up to 2 years after the date of the last enrolled participants
Relapse free survival
The interval from CR to the date of relapse, or the date of death, or the date of last follow-up, whichever occurred first. This outcome analyzes patients achieved CR in two courses of induction therapy.
Measured: up to 2 years after the date of the last enrolled participants
30-day mortality
Percentage of patients who died within 30 days from enrollment
Measured: Within 30 days of the date of the last enrolled participants
60-day mortality
Percentage of patients who died within 60 days from enrollment
Measured: Within 60 days of the date of the last enrolled participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start8 Oct 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FLT3 Gene MutationStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Wei, doctor, Principal investigator, Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06561880
- Sponsor's protocol ID
- IIT2024055
- Acronym
- FLT3AML-2024
- Status last verified
- May 2026
- First submitted
- 8 Aug 2024
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang ES, Goldberg AD, Tallman M, Walter RB, Karanes C, Sandhu K, Vigil CE, Collins R, Jain V, Stone RM. Crenolanib and Intensive Chemotherapy in Adults With Newly Diagnosed FLT3-Mutated AML. J Clin Oncol. 2024 May 20;42(15):1776-1787. doi: 10.1200/JCO.23.01061. Epub 2024 Feb 7.
PubMed 38324741Department of Error. Lancet. 2023 Oct 14;402(10410):1328. doi: 10.1016/S0140-6736(23)02235-3. No abstract available.
PubMed 37838437Knight TE, Edwards H, Meshinchi S, Taub JW, Ge Y. "FLipping" the Story: FLT3-Mutated Acute Myeloid Leukemia and the Evolving Role of FLT3 Inhibitors. Cancers (Basel). 2022 Jul 13;14(14):3398. doi: 10.3390/cancers14143398.
PubMed 35884458
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Triple Regimen Including Gilteritinib, Venetoclax, and Azacitidine in Newly Diagnosed Fit AML Patients With FLT3 Mutation
- ClinicalTrials.gov ID
- NCT06561880
- Acronym / sponsor ID
- FLT3AML-2024 / IIT2024055
- Conditions
- FLT3 Gene Mutation, AML
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Aug 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.
The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.
Detailed description
This stuay intends to conduct a clinical study to explore the efficacy and safety of the triple induction regimen consisting of Gilteritinib, Venetoclax, and Azacitidine in newly diagnosed FLT3 mutated AML patients who are suitable for intensive chemotherapy. Patients will receive 2 courses of triple regimen therapy for induction and those who achieved complete remission will receive 3 courses of intermediate-dose cytarabine for consolidation. After consolidation therapy, dose-adjusted triple regimen therapy will be applied for 6 courses as maintenance treatment. Bone marrow morphology and minimal residual disease detected by flow cytometry and next-generation sequencing will be monitored during the treatment to provide evidence for treatment decisions. Response and survival of patients will be recorded to evaluate the efficacy of the triple regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triple Regimen Induction of Arm1 | Experimental | Drug: Venetoclax, Drug: Cytarabine, Drug: Gilteritinib, Drug: Azacitadine (AZA)Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-14; Venetoclax: 100mg d1, 200mg d2, 400mg d3-14 |
| Triple Regimen Induction of Arm2 | Experimental | Drug: Venetoclax, Drug: Cytarabine, Drug: Gilteritinib, Drug: Azacitadine (AZA)Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-14; Venetoclax: 100mg d1, 200mg d2, 400mg d3-7 |
| Triple Regimen Induction of Arm3 | Experimental | Drug: Venetoclax, Drug: Cytarabine, Drug: Gilteritinib, Drug: Azacitadine (AZA)Patients will receive induction with a triple regimen therapy: Azacitidine 75mg/m2/d d1-7; Gilteritinib: 120mg d1-7; Venetoclax: 100mg d1, 200mg d2, 400mg d3-7 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.
- Age ≥15 years old, male or female.
- The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.
- Pass the requirements of the following laboratory tests (performed within 7 days before treatment) :
- 1) Total bilirubin ≤ 1.5 times the upper limit of normal value (same age); 2) AST and ALT≤ 2.5 times the upper limit of normal value (same age); 3) Blood creatinine < 2 times the upper limit of normal (same age); 4) Myocardial enzymes < 2 times the upper limit of normal (same age); 5) Echocardiography (ECHO) was performed to determine the ejection fraction of the heart within the normal range.
Key exclusion criteria (7 listed)
- Acute promyelocytic leukemia with PML-RARA fusion gene
- Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene
- Acute myeloid leukemia with BCR-ABL fusion gene
- Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy).
- Concurrent malignant tumors of other organs (those requiring treatment).
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 |
|---|---|---|
| VenetoclaxVenetoclax dose and schedule determined by arms and treatment phases | Drug | Triple Regimen Induction of Arm1, Triple Regimen Induction of Arm2, Triple Regimen Induction of Arm3 |
| CytarabineAlso: GilteritinibConsolidation therapy (3 courses): intermediate-dose cytarabine regimen :2g/m2 q12h d1-3, age < 60 years;1g/m2 q12h d1-3, age ≥60 years. If NGS detected FLT3 mutation before consolidation chemotherapy, gilteritinib will be added during the consolidation course at d4-17. | Drug | Triple Regimen Induction of Arm1, Triple Regimen Induction of Arm2, Triple Regimen Induction of Arm3 |
| GilteritinibGilteritinib 120mg schedule determined by arms or treatment phases | Drug | Triple Regimen Induction of Arm1, Triple Regimen Induction of Arm2, Triple Regimen Induction of Arm3 |
| Azacitadine (AZA)Azacitidine 75mg/m2/d schedule determined by treatment phases | Drug | Triple Regimen Induction of Arm1, Triple Regimen Induction of Arm2, Triple Regimen Induction of Arm3 |
Primary outcome
Composite Complete remission (CRc) rate
Time frame: up to 3 months after the date of the last enrolled participants
The ratio of patients achieved CRc（CR/CRh/CRi) after induction therapy
Composite Complete remission (CRc) with negative MRD detected by flow cytometry.
Time frame: up to 1 years after the date of the last enrolled participants
The ratio of CRc with negative MRD detected by flow cytometry after induction, consolidation, and maintenance therapy.
To determine the tolerated dose of triple regimens
Time frame: up to 3 months after enrollment of the first participants
The dose of gilteritinib and venetoclax that can be safely combined with azacitidine
Event-free survival (EFS)
Time frame: up to 2 years after the date of the last enrolled participants
The interval from the date of enrollment to the date of failed to achieve complete remission, the date of relapse, or the date of death, whichever occurred first.
5 secondary outcomes
CRc with negative MRD detected by NGS (next-generation sequencing)
Time frame: up to 1 years after the date of the last enrolled participants
overall survival
Time frame: up to 2 years after the date of the last enrolled participants
Relapse free survival
Time frame: up to 2 years after the date of the last enrolled participants
30-day mortality
Time frame: Within 30 days of the date of the last enrolled participants
60-day mortality
Time frame: Within 60 days of the date of the last enrolled participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Results publication: PubMed 38324741Wang ES, Goldberg AD, Tallman M, Walter RB, Karanes C, Sandhu K, Vigil CE, Collins R, Jain V, Stone RM. Crenolanib and Intensive Chemotherapy in Adults With Newly Diagnosed FLT3-Mutated AML. J Clin Oncol. 2024 May 20;42(15):1776-1787. doi: 10.1200/JCO.23.01061. Epub 2024 Feb 7.
- Results publication: PubMed 37838437Department of Error. Lancet. 2023 Oct 14;402(10410):1328. doi: 10.1016/S0140-6736(23)02235-3. No abstract available.
- Results publication: PubMed 35884458Knight TE, Edwards H, Meshinchi S, Taub JW, Ge Y. "FLipping" the Story: FLT3-Mutated Acute Myeloid Leukemia and the Evolving Role of FLT3 Inhibitors. Cancers (Basel). 2022 Jul 13;14(14):3398. doi: 10.3390/cancers14143398.
- Individual participant dataSharing planned: No
Related trials for FLT3 Gene Mutation
RecruitingPhase 1/2
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia
Not yet recruitingPhase 2
Gilteritinib-Azacitidine-Venetoclax Combination Therapy in Patients With Relapsed/Refractory Leukemia
Acute Myeloid Leukemia, AML With FLT3 Mutation
RecruitingPhase 1/2
ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
Acute Myeloid Leukemia, Myelodysplastic Syndrome
RecruitingPhase 1
A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease
Acute Myeloid Leukemia, Acute Myeloid Leukemia With KMT2A Rearrangement
Active, not recruitingPhase 1
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
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.
Hui Wei, doctor principal investigator
Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Venetoclax, Cytarabine and Gilteritinib in people with FLT3 Gene Mutation and AML, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Wei, Doctor (13132507161, weihui@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Complete remission (CRc) rate (time frame: up to 3 months after the date of the last enrolled participants). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06561880, which also lists 3 linked publications.
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 13 May 2026.