Fostamatinib in Patients with Diffuse Large B-Cell Lymphoma
Research type
Research Study
Full title
A Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
IRAS ID
100859
Contact name
Kirit Ardeshna
Sponsor organisation
AstraZeneca AB
Eudract number
2011-005371-16
Clinicaltrials.gov Identifier
Research summary
This study is being done in research subjects with diffuse large B-cell lymphoma (DLBCL) that has either come back after therapy or that has become worse. Fostamatinib is an investigational drug being studied in a variety of diseases including rheumatoid arthritis, a type of thrombocytopenia (low platelet counts), and lymphoma. Fostamatinib is an inhibitor of the enzyme, spleen tyrosine kinase (Syk). Lymphoma cell multiplication and survival is linked to this enzyme and so fostamatinib may inhibit and eliminate these lymphoma cells. In this study, fostamatinib will be tested at 2 different doses: ?½ 200 mg twice daily and ?½ 100 mg twice daily Evidence of anti-tumour activity was observed in subjects with DLBCL treated with 200 mg fostamatinib twice daily in a previous study. The dose currently being studied in people with rheumatoid arthritis is 100 mg twice daily. The purpose of this trial is to evaluate the effectiveness and side effects of treatment with both doses of fostamatinib in DLBCL. This trial will also evaluate the drug concentrations in the body to learn how fostamatinib is processed by the body.
REC name
London - Harrow Research Ethics Committee
REC reference
12/LO/0758
Date of REC Opinion
30 Jul 2012
REC opinion
Further Information Favourable Opinion