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Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients. — REALISE  

Primary Myelofibrosis Clinical Trial

Official title:
A Multicenter Phase II, Open Label, Single Arm Study to Evaluate the Efficacy and Safety of Ruxolitinib in the Treatment of Anemic Myelofibrosis Patients.

Clinical Trial Summary

This was a study of treatment with ruxolitinib in patients who presented with transfusion dependent or independent anemia. Starting dose was 10 mg BID. This dose was maintained for the first 12 weeks of the study and up-titrated thereafter unless the subject met criteria for dose hold or dose reduction

Clinical Trial Description

This was a study of treatment with ruxolitinib in patients who present with transfusion dependent or independent anemia at screening defined as an hemoglobin <10 g/dL with 10 mg BID starting dose with subsequent up titrations (maximum dose 25 mg BID) depending on safety and efficacy. This dosing approach for anemic MF patients will be systematically studied in this prospective multicenter phase II open label single arm trial to determine if the levels of spleen length reduction and symptom improvement are consistent with those reported in previous clinical trials with ruxolitinib in patients with anemia and doses according to platelet counts at the moment of treatment initiation, and whether this lower starting dose and up titration approach may minimize the initial hemoglobin and platelet declines and transfusion requirements. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02966353
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 2
Start date March 31, 2017
Completion date February 15, 2019
View Details
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