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

NCT ID: NCT06734585

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 114 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2025-07-14

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

Gilteritinib

Intervention Type: DRUG

tablet, oral

Interventions

Gilteritinib

tablet, oral

Intervention Type: DRUG

Other Intervention Names

ASP2215; XOSPATA®

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Singapore Pte. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Singapore Pte. Ltd.

Locations

AU61001

Melbourne, , Australia

AU61002

Melbourne, , Australia

BR55004

Fortaleza, , Brazil

BR55002

Porto Alegre, , Brazil

BR55001

São Paulo, , Brazil

BR55003

São Paulo, , Brazil

CN86003

Shanghai, , China

CN86004

Suzhou, , China

CN86001

Tianjin, , China

HK852001

Hong Kong, , Hong Kong

KR82004

Busan, , South Korea

KR82005

Gwangju, , South Korea

KR82001

Seoul, , South Korea

KR82002

Seoul, , South Korea

KR82003

Seoul, , South Korea

TW88603

Taichung, , Taiwan

TW88602

Tainan City, , Taiwan

TW88601

Taipei, , Taiwan

Countries

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

Other Identifiers

2215-MA-3574

Identifier Type: -

Identifier Source: org_study_id