M16-109 Phase 2 Single Arm Study on Patients with Myelofibrosis
Research type
Research Study
Full title
A Phase 2 Single-Arm, Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax in Combination with Ruxolitinib in Subjects with Myelofibrosis
IRAS ID
229938
Contact name
Claire Harrison
Contact email
Sponsor organisation
AbbVie Ltd
Eudract number
2017-001398-17
Duration of Study in the UK
2 years, 5 months, 9 days
Research summary
Myelofibrosis (MF) is an uncommon type of illness that affects the blood-forming tissues in the body. MF is a serious bone marrow illness that disrupts the body's normal production of blood cells. It results in extensive scarring in the bone marrow, leading to severe anaemia, weakness, fatigue and an enlarged spleen.
Many people with myelofibrosis get progressively worse, and some may develop a form of leukaemia.
An accepted treatment for MF is a drug called Ruxolitinib that helps with symptoms. However when ruxolitinib is stopped, the patient develops the MF symptoms again. The only treatment that currently controls all the symptoms of MF is a stem cell transplant but this treatment is not suitable for most patients; therefore there is a real need to develop new strategies including trying combinations of treatments.
Navitoclax is an experimental drug that kills cancer cells by blocking a protein that allows cancer cells to stay alive. It has been shown to have an effect on cells that cause MF
This study is in patients with MF who are currently receiving ruxolitinb and becoming symptomatic and is designed to see if adding navitoclax to ruxolitinib works better than ruxolitinb on its own. All the patients will receive both treatments. AbbVie is funding this study which will enrol about 34 patients in 15 sites in the USA and the UK.
The effect of the treatment on MF will be checked by taking MRI measurements of spleen size, blood and bone marrow samples, measuring side effects and by completing symptom questionnaires. Patients will continue to have study visits and receive treatment for as long as their improvements are greater than their side effects.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0493
Date of REC Opinion
4 Oct 2017
REC opinion
Further Information Favourable Opinion