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

NCT06734585 | Completed

• 1 other identifier: 2215-MA-3574
• Study Type: observational
• Target: 114
• Locations: 6 countries
• Sites: 18

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

Keywords

Gilteritinib; Xospata; Relapsed or refractory FLT3m+ Acute Myeloid Leukemia (AML); Hematopoietic Stem Cell Transplantation (HSCT); Best Supportive Care

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after index date (90 days post-HSCT)

Secondary Outcomes (3)

• Overall Survival (OS)

  Up to 24 months after index date (90 days post-HSCT)

• Graft-versus-host disease (GvHD)-free relapse-free survival (GFS)

  12 months after index date (90 days post-HSCT)

• Cumulative Incidence of Relapse

  Up to 24 months

Study Arms (2)

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.

Drug: Gilteritinib

Interventions

Gilteritinib DRUG

tablet, oral

Also known as: ASP2215, XOSPATA®

Gilteritinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Singapore Pte. Ltd.: lead

Study Sites (18)

AU61001

Melbourne, Australia

Location

AU61002

Melbourne, Australia

Location

BR55004

Fortaleza, Brazil

Location

BR55002

Porto Alegre, Brazil

Location

BR55001

São Paulo, Brazil

Location

BR55003

São Paulo, Brazil

Location

CN86003

Shanghai, China

Location

CN86004

Suzhou, China

Location

CN86001

Tianjin, China

Location

HK852001

Hong Kong, Hong Kong

Location

KR82004

Busan, South Korea

Location

KR82005

Gwangju, South Korea

Location

KR82001

Seoul, South Korea

Location

KR82002

Seoul, South Korea

Location

KR82003

Seoul, South Korea

Location

TW88603

Taichung, Taiwan

Location

TW88602

Tainan, Taiwan

Location

TW88601

Taipei, Taiwan

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Interventions

gilteritinib

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Central Contact

  Astellas Pharma Singapore Pte. Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: January 9, 2025
• Primary Completion: July 14, 2025
• Study Completion: July 14, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1); TW (3); AU (2); BR (4); CN (3); KR (5)