Using Gilteritinib to prevent cancer recurrence after stem cell transplant in AML patients
A Comparison Between Gilteritinib in Phase 3 Trials Versus Real-World External Comparator Cohort of Relapsed/Refractory (R/R) FLT3m+ Acute Myeloid Leukemia (AML) Patients After Hematopoietic Stem Cell Transplantation (HSCT)
This study tests if the drug gilteritinib can help prevent cancer from coming back in people with acute myeloid leukemia who have had a stem cell transplant and have a specific genetic mutation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Astellas Pharma Inc Industry-sponsored |
| Drugs / interventions | Gilteritinib, chemotherapy, radiation |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06734585 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of gilteritinib in prolonging remission in patients with acute myeloid leukemia (AML) who have undergone a stem cell transplant. It compares two groups: one receiving gilteritinib post-transplant and another receiving standard care. The focus is on patients with a specific genetic mutation (FLT3) that can lead to faster cancer recurrence. The study aims to gather data on how well gilteritinib helps maintain cancer-free status after treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with AML who have the FLT3 mutation and have undergone a stem cell transplant.
Not a fit: Patients without the FLT3 mutation or those who have not undergone a stem cell transplant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly extend the time patients remain cancer-free after a stem cell transplant.
How similar studies have performed: Previous studies, such as the ADMIRAL and COMMODORE studies, have shown promising results with gilteritinib in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hong Kong
- Hk852001 — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Study coordinator: Astellas Pharma Singapore Pte Ltd
- Email: Astellas.registration@astellas.com
- Phone: 800-888-7704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.