Myeloproliferative Neoplasms (MPNs) are uncommon diseases that in some cases will progress to an acute leukaemia which is very difficult to treat. As this often happens to older people, most patients are unsuitable for bone marrow transplant therapy. There are few other treatment options for these patients and survival is only around 6 months.
This trial will combine a treatment (ruxolitinib) that is effective at symptom control and may confer a survival advantage in myelofibrosis (an MPN) with azacitidine, a treatment that has proven activity in patients with some types of myelodysplastic syndrome and acute myeloid leukaemia. As these two treatments have not been used together before, the trial will consist of a dose finding component, followed by the recruitment of an additional 10 patients at the maximum dose that is found to be safe and tolerable.
Side-effects are anticipated to be similar to those experienced with these treatments used alone. In particular, low blood counts and infections are potential risks although measures to reduce these risks will be taken.
In addition to patients recruited to receive trial treatment, the study will also recruit patients with these diseases who do not want to receive the trial treatment and monitor them for outcome.
Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible
| Chief Investigator: Dr Mark Drummond |
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| Sponsor: University of Birmingham |
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| Funders: Bloodwise as part of their Trials Acceleration Programme (TAP) |
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| Disease Site: Myeloproliferative Neoplasms |
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| Trial Type: Clinical Trial of an Investigational Medicinal Product |
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| Status: Open |
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| UKCRN Study ID: 18136 |
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| Open to New Sites? No |
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| Recruitment Start Date: 05-Jan-2016 |
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| Anticipated Recruitment End Date: 31-Dec-2018 |
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| CRCTU Trial Management Team: Haematology |
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| Trial E-mail Address: Phazar@Trials.bham.ac.uk |
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