MITHRIDATE: Ruxolitinib Versus Hydroxycarbamide or Interferon as First Line Therapy in High Risk Polcythemia Vera
Summary
The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.
Description
The trial will be a phase III, randomised-controlled, multi-centre, international, open-label trial consisting of ruxolitinib versus best available therapy, where best available therapy is a choice of interferon alpha, any formulation permitted (IFN) or hydroxycarbamide (HC), and which will be elected by the Investigator prior to randomisation.
There will be no cross-over either between arm A and B or between therapies on Arm B
HC and IFN will be provided as best available therapy, IFN can include standard of pegylated-interferon at Investigators discretion.
Study Design
Conditions
Polycythemia Vera
Intervention
Ruxolitinib, Hydroxycarbamide, Interferon-Alpha
Status
Not yet recruiting
Source
University of Birmingham
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04116502
- ClinicalTrials.gov processed this data on October 09, 2019
Published on BioPortfolio: 2019-10-10T09:39:36-0400
Clinical Trials
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TGR-1202 + Ruxolitinib PMF PPV-MF PET-MF MDS/MPN Polycythemia Vera Resistant to Hydroxyurea
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Efficacy and Safety of Pegylated Interferon Alfa in Polycythemia Vera
Interferon alfa is an effective treatment of polycythemia vera (PV), but about 20% of patients discontinue their treatment because of side effects and treatment schedule (three times per w...
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The aim of this research is to look at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV c...
PubMed Articles
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Treatment strategies for polycythemia vera: observations in a Dutch 'real world' cohort study.
Assessment of 'real-world' treatment strategies and outcome in Dutch Polycythemia Vera (PV) patients.
Outcomes Following Posterior Lumbar Fusion in Polycythemia Vera Patients.
Polycythemia Vera (PV) is a chronic myeloproliferative neoplasm that is associated with an increased risk for venous and arterial thromboembolism. The aim of this study is to evaluate outcomes followi...
JAK2V617F is the most common mutation in patients with BCR-ABL negative myeloproliferative neoplasms (MPNs). The eradication of JAK2V617F hematopoietic stem cells (HSCs) is critical for achieving mole...
Perioperative management of polycythemia vera with advanced gastric cancer: A case report.
Polycythemia vera (PV) is a chronic myeloproliferative disorder with generally good prognosis. However, thrombotic and cardiovascular complications are among the leading causes of death in patients wi...
Medical and Biotech [MESH] Definitions
Interferon Type I
Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).
Receptor, Interferon Alpha-beta
A ubiquitously expressed heterodimeric receptor that is specific for both INTERFERON-ALPHA and INTERFERON-BETA. It is composed of two subunits referred to as IFNAR1 and IFNAR2. The IFNAR2 subunit is believed to serve as the ligand-binding chain; however both chains are required for signal transduction. The interferon alpha-beta receptor signals through the action of JANUS KINASES such as the TYK2 KINASE.
Phlebotomy
The techniques used to draw blood from a vein for diagnostic purposes or for treatment of certain blood disorders such as erythrocytosis, hemochromatosis, polycythemia vera, and porphyria cutanea tarda.
Interferon Regulatory Factor-1
An interferon regulatory factor that binds upstream TRANSCRIPTIONAL REGULATORY ELEMENTS in the GENES for INTERFERON-ALPHA and INTERFERON-BETA. It functions as a transcriptional activator for the INTERFERON TYPE I genes.
Polycythemia Vera
A myeloproliferative disorder of unknown etiology, characterized by abnormal proliferation of all hematopoietic bone marrow elements and an absolute increase in red cell mass and total blood volume, associated frequently with splenomegaly, leukocytosis, and thrombocythemia. Hematopoiesis is also reactive in extramedullary sites (liver and spleen). In time myelofibrosis occurs.
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