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Could gilteritinib keep AML in remission longer after transplant?

NCT ID NCT06734585

Knowledge-focused Sponsor: Astellas Pharma Singapore Pte. Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 2 times

Summary

This study looked at people with a type of leukemia (AML) that has a FLT3 gene change, which makes the cancer grow faster. After a stem cell transplant, some patients took the drug gilteritinib in earlier trials, while others received standard care. Researchers compared medical records to see if gilteritinib helped keep patients cancer-free longer. The study only collected existing data and did not provide any new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Gilteritinib (XOSPATA)
What this could lead to
If successful, this could confirm that gilteritinib helps keep FLT3-mutated AML patients cancer-free longer after a stem cell transplant, supporting its approval in more countries.
What could go wrong
This is an observational study using data from past trials and medical records, not a new treatment test. Results may not apply to all patients, and the comparison groups may differ in ways that affect outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

114 people

The number who actually took part.

Started

Jan 2025

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. 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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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia

Contacts and locations

Locations

  • AU61001

    Melbourne, Australia

  • AU61002

    Melbourne, Australia

  • BR55001

    São Paulo, Brazil

  • BR55002

    Porto Alegre, Brazil

  • BR55003

    São Paulo, Brazil

  • BR55004

    Fortaleza, Brazil

  • CN86001

    Tianjin, China

  • CN86003

    Shanghai, China

  • CN86004

    Suzhou, China

  • HK852001

    Hong Kong, Hong Kong

  • KR82001

    Seoul, South Korea

  • KR82002

    Seoul, South Korea

  • KR82003

    Seoul, South Korea

  • KR82004

    Busan, South Korea

  • KR82005

    Gwangju, South Korea

  • TW88601

    Taipei, Taiwan

  • TW88602

    Tainan, Taiwan

  • TW88603

    Taichung, Taiwan

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