PHAZAR: A phase Ib study to assess the safety and tolerability of oral Ruxolitinib in combination with 5-azacitidine in patients with advanced phase myeloproliferative neoplasms (MPN), including myelodysplastic syndromes (MDS) or acute myeloid leukaemia (AML) arising from MPN.

Trial Overview and Summary

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  
Sponsor: University of Birmingham  
Funders: Bloodwise as part of their Trials Acceleration Programme (TAP)  
Disease Site: Myeloproliferative Neoplasms  
Trial Type: Clinical Trial of an Investigational Medicinal Product  
Status: Open  
UKCRN Study ID: 18136  
Open to New Sites? No  
Recruitment Start Date: 05-Jan-2016  
Anticipated Recruitment End Date: 31-Dec-2018  
CRCTU Trial Management Team: Haematology  
Trial E-mail Address:  

Trial Protocol

Please Note:

Clinical trial protocols are complex technical documents which should only be used for the treatment of subjects taking part in the trial. Patients who are interested in taking part in the trial are advised to talk to their health care professional or refer to CancerHelp website.

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.

Trial Documents [opens a new page]