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

Launched by ASTELLAS PHARMA SINGAPORE PTE. LTD. · Dec 11, 2024

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ClinConnect Summary

This clinical trial is studying a medication called gilteritinib to see if it helps people with acute myeloid leukemia (AML) stay cancer-free after they have a stem cell transplant. AML is a type of blood cancer that can return after treatment, especially in patients with a specific genetic change called the FLT3 mutation. The trial aims to gather information from patients who received standard post-transplant care and compare it with data from those who took gilteritinib after their transplant. By looking at their medical records, researchers hope to understand how long patients can remain in remission without their cancer coming back.

To be eligible for this study, participants must have been diagnosed with AML and have the FLT3 mutation. They should have undergone a stem cell transplant and be alive 90 days after the procedure, showing signs of recovery. This study is observational, meaning that researchers will collect information without providing any treatment. Patients can expect their medical data to be reviewed, focusing on their health outcomes after the transplant, including any relapses or other significant events. It's important to note that this study is currently recruiting participants, and it is sponsored by Astellas, a pharmaceutical company.

Gender

ALL

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