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 MP

The University of Birmingham (UK)0 sites58 target enrollmentMarch 19, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Myeloproliferative neoplasms (MPN), including myelodysplastic syndromes (MDS) or acute myeloid leukaemia (AML) arising from MPN
Sponsor: The University of Birmingham (UK)
Enrollment: 58
Status: Completed
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

March 19, 2015

End Date

August 18, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

The University of Birmingham (UK)

•Current participant inclusion criteria as of 01/08/2018:
•For the Interventional component:
•1\. Age \= 16 years old
•2\. A prior diagnosis of Essential Thrombocythaemia (ET), Polycythaemia Vera (PV) or Myelofibrosis (MF) with one of the following:
•2\.1\. \= 10% blasts in blood or bone marrow with or without dysplastic changes (MPN\-AP) at baseline
•2\.2\. \= 20% blasts in blood or bone marrow (MPN\-BP) at baseline
•3\. In need of treatment in the opinion of the investigator
•4\. Eastern Cooperative Oncology Group (ECOG) performance status 0\-3
•5\. Adequate liver and renal function, defined as:
•5\.1\. Liver transaminases \= 3 × ULN (AST/SGOT and ALT/SGPT)

•Current participant exclusion criteria as of 01/08/2018:
•For the Interventional Component:
•1\. Any co\-morbidity that could limit compliance with the trial or any other condition (including laboratory abnormalities) that in the Investigators opinion will affect the patient’s participation in this trial
•2\.New York Heart Association Class II, III, or IV congestive heart failure
•3\. On\-going cardiac dysrhythmias of grade 3, QTc prolongation \>480 ms, or other factors that increase the risk of QT interval prolongation (e.g. heart failure, hypokalemia defined as serum potassium \<3\.0 mEq/L, family history of long QT interval syndrome)
•4\. Erythropoietic agent within 28 days prior to registration
•5\. Thrombopoietic agent within 14 days prior to registration
•6\. CYP3A4 inhibitor within 7 days prior to registration
•7\. Experimental treatment for AML or MPN within 14 days prior to registration (except Ruxolitinib and Hydroxycarbamide which can be taken up until study entry at the prestudy dose. Hydroxycarbamide must be stopped before the first scheduled day of treatment)
•8\. Previously received 5\-azacitidine