Phase 1b/2 Study of Lanraplenib in Acute Myeloid Leukemia
A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) (NCT05028751)
Lanraplenib (oral SYK inhibitor)
The Phase 1b/2 trial is enrolling patients with relapsed or refractory FLT3-mutated acute myeloid leukemia.
This trial is being conducted in two stages: a dose-escalation stage and an expansion stage. The first stage is evaluating initial safety, PK and anti-leukemic activity of escalating once-daily doses of lanraplenib in combination with the standard approved dose of gilteritinib. This stage also will assess FLT3 measurable residual disease (MRD negative rate) in patients who achieve a complete response (CR) and explore the predictive value of a number of biomarkers that may correlate with clinical outcomes.
Once a recommended dose is established, an expansion is planned to further evaluate the safety of lanraplenib and assess its anti-leukemic activity as measured by composite CR rate and duration of response.
We have sites open in the United States. For a list of sites, click here.
Fms-like tyrosine kinase 3 (FLT3) is the most common genetic alteration in AML, present in approximately one-third of patients.