Overview

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

Status:
Completed

Trial end date:
2020-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

The University of Hong Kong

Treatments:

Niacinamide
Sorafenib

Criteria

Inclusion Criteria:

- 1. Patients with AML carrying Flt3 mutation; AND,

- 2. Patients with persistent leukemia despite at least two prior chemotherapy regimens

Exclusion Criteria:

- Patients who are considered not fit for any form of leukemia treatment by the
attending hematologists