drugset / Trial / NCT03622541

Using Sorafenib as a Salvage Treatment for Relapsed or Refractory Acute Myeloid Leukemia Carrying FLT3-ITD

NCT03622541 ↗

Phase 2 Completed 46 enrolled The University of Hong Kong
NaSingle-groupOpen-labelTreatment

Summary

Patients with refractory or relapsed acute myeloid leukemia (AML) after two courses of standard chemotherapy regimens have very limited options. Further chemotherapy is associated with significant toxicity and is generally ineffective. About 10-30% patients with AML carry a gain-of-function mutation of a gene known as Flt3 in the leukemic cells, conferring them with abnormal cellular proliferation. Sorafenib is a multi-kinase inhibitor which was licensed in Hong Kong for the treatment of advanced hepatocellular and renal cell carcinoma. The drug has also been shown to be effective against Flt3 and AML but it has not been licensed for use in this condition.

Timeline

Start
2010-11-15
Primary completion
2019-12-01
Completion
2020-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Sorafenib Small molecule 200 mg —