Phase 2 Study Evaluating Oral Azacitidine Added to Gilteritinib Treatment for Adults 18 and Older With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia

What this Trial Is About

Researchers are studying adults with relapsed or refractory FLT3-mutated acute myeloid leukemia AML, a type of blood cancer with poor prognosis and high relapse rates. The study aims to assess whether adding oral azacitidine to the salvage treatment with gilteritinib improves treatment outcomes. This phase 2, open-label trial focuses on patients who have not responded to or have relapsed after first-line intensive chemotherapy and have specific FLT3 gene mutations. Participants receive a combination of gilteritinib 120 mg daily and oral azacitidine 300 mg daily on days 1 to 14 of a 28-day cycle. Gilteritinib is an approved treatment for this condition, and oral azacitidine is being studied as an addition to enhance efficacy. The study uses continuous 28-day treatment cycles and monitors responses over at least three months, with follow-up extending throughout the treatment period. During the study, participants will be closely monitored for treatment response, including rates of complete remission and remission with incomplete blood count recovery. Safety is assessed by tracking adverse events and early deaths. Regular evaluations include laboratory tests, organ function assessments, and quality of life measures. The primary outcome is the rate of composite complete remission within the first three months of treatment, with secondary outcomes focusing on safety and detailed remission rates over six months. Total participation time varies based on treatment duration and response.

Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia