A Phase IB/II Study of Lanraplenib in Combination with Gilteritinib in People with FLT3-Mutated Recurrent or Persistent Acute Myeloid Leukemia

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Full Title

A Phase 1b/2 Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of the Selective SYK Inhibitor Lanraplenib (LANRA) in Combination with the FLT3 Inhibitor Gilteritinib, in Patients with FLT3-mutated Relapsed or Refractory AML

Purpose

The purpose of this study is to find the highest dose of the drug lanraplenib that can be given safely with gilteritinib in patients with recurrent or persistent acute myeloid leukemia (AML) that contains a mutation in the FLT3 gene. Both drugs work by targeting and blocking the FLT3 protein, which promotes the growth and spread of cancer cells. They are taken orally (by mouth).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have AML that came back or continues to grow despite prior treatment and has an FLT3 mutation.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Eytan Stein at 646-608-3749.

Protocol

22-193

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05028751