Monocle
Research type
Research Study
Full title
A phase 2 study of the monocyte-targeted histone deacetylase inhibitor tefinostat (CHR-2845) in chronic myelomonocytic leukaemia (CMML)
IRAS ID
180498
Contact name
Steven Knapper
Contact email
Eudract number
2015-002281-23
ISRCTN Number
ISRCTN17394489
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Chronic myelomonocytic leukaemia (CMML) is an uncommon form of cancer that causes a build up of cells called monocytes in the bone marrow and blood. It mainly effects older people and the average length of survival is only 11-17 months. Most patients with CMML are unsuitable for bone marrow transplant therapy and there are currently very few other treatment options. There is a pressing need for new drug treatments
which can target the abnormal monocytes without causing unacceptable side effects.Tefinostat is a new drug, taken by mouth as a capsule, which only becomes active after it is inside monocytes. In laboratory studies, tefinostat was effective against monocytic tumours and, in a small 'phase 1' clinical trial in 18 bone marrow cancer patients, it was shown to target monocytes without causing side effects.
In this 'phase 2' trial, 40 patients with CMML will be treated at different hospitals in the UK to allow us to test the effectiveness of tefinostat in CMML as well as monitoring for side effects. Blood and bone marrow samples from patients will be tested in the laboratory to help us better understand how tefinostat works and to identify which patients are most likely to benefit in future.
REC name
Wales REC 3
REC reference
15/WA/0391
Date of REC Opinion
15 Jan 2016
REC opinion
Further Information Favourable Opinion