Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant

Plain-language summary

This study examined the use of Gilteritinib to maintain remission after a stem cell transplant in people with acute myeloid leukemia (AML). It included FLT3-mutation-positive patients who had an allogeneic stem cell transplant for relapsed/refractory AML and received Gilteritinib afterward, along with a comparison group. It was a non-phase study that has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Astellas Pharma Singapore Pte. Ltd.

Intervention

Gilteritinib

Start date

1/9/2025

Estimated completion

7/14/2025

Countries

Australia, Brazil, China, Hong Kong, South Korea, Taiwan

Related genes

Locations

• Melbourne, Australia
• Melbourne, Australia
• Fortaleza, Brazil
• Porto Alegre, Brazil
• São Paulo, Brazil
• São Paulo, Brazil
• Shanghai, China
• Suzhou, China
• Tianjin, China
• Hong Kong, Hong Kong
• Busan, South Korea
• Gwangju, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Taichung, Taiwan
• Tainan, Taiwan
• Taipei, Taiwan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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