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A Clinical Study of Ruxolitinib in Patients With Primary Myelofibrosis (PM), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis | Clinical Trials | Clareo Health

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A Clinical Study of Ruxolitinib in Patients With Primary Myelofibrosis (PM), Post-polycythemia Vera (PV) Myelofibrosis, or Post-essential Thrombocythemia (ET) Myelofibrosis

A Multicenter, Open-label Clinical Study of the JAK Inhibitor Ruxolitinib (INC424) in Patients With Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis

NCT02087059•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter clinical study in order to collect and examine data concerning the safety and efficacy of ruxolitinib in patients with Primary Myelofibrosis (MF), Post-Polycythemia Vera (PV) MF, Post-Essential Thrombocythemia (ET) MF.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years of age
•2. Diagnosis of PMF, PPV-MF, or PET-MF, regardless of JAK2 mutational status. The diagnostic of PMF will be according to the World Health Organization (WHO) criteria (Thiele et al., 2008) and PPV-MF and PET-MF according to the International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria (Barosi et al., 2008).
•3. At least one risk factors provided in the definition of IWG-MRT (Cervantes et al., 2009; classified as intermediate risk-1, intermediate risk-2, or high risk)
•4. Patients with intermediate risk-1 (patients who have only one of the IMG-MRT risk factors indicated above ) must have palpable splenomegaly with a length of ≥5 cm from the costal margin to the point of the greatest spleen protrusion.
•5. Proportion of blasts in peripheral blood \<10%
•6. ECOG performance status of 0 to 2
•7. The following values for bone marrow function prior to treatment:
•1. Absolute neutrophil count ≥1,000/μL, and
•2. Platelet count ≥50,000/μL without administration of a growth factor, thrombopoietin, or platelet transfusion
•8. Stem cell transplantation is not a treatment option at present because it is not indicated or because there are no suitable donors.
+2 more criteria

Exclusion Criteria

•1. Hepatic or renal impairment as indicated by the following:
•* Direct bilirubin ≥2-fold than the upper limit of normal (ULN)
•* Alanine aminotransferase (ALT) \>2.5-fold ULN
•* Creatinine \>2.0 mg/dL
•2. Clinically significant infection by bacteria, fungus, mycobacteria, parasite, or virus (screening and enrollment postponed until completion of antibiotic treatment in patients with an acute bacterial infection that requires antibiotic use)
•3. Active hepatitis A, B, or C or HIV infection defined by a positive IgM-HA Ab test \[hepatitis A virus antibody (immunoglobulin M \[IgM\])\], HBs Ag test (hepatitis B surface antigen), HCV Ab test (hepatitis C virus antibody), or HIV Ab (human immunodeficiency virus antibody) at screening.
•4. History of malignancy within the previous 3 years, except for early-stage squamous cell carcinoma and basal cell carcinoma.
•5. History of serious congenital or acquired hemorrhagic disease
•6. Previous platelet count \<25,000/μL or absolute neutrophil count \<500/μL, except for patients currently undergoing treatment for a myeloproliferative neoplasm or cytotoxic therapy for any other reason.
•7. Splenic irradiation within 12 months before screening
+10 more criteria

Locations (29)

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Akita, Akita, Japan

Novartis Investigative Site

Matsuyama, Ehime, Japan

Novartis Investigative Site

Tōon, Ehime, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Kurume, Fukuoka, Japan

Novartis Investigative Site

Gifu, Gifu, Japan

Novartis Investigative Site

Maebashi, Gunma, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Key Dates

Start Date

April 1, 2014

Primary Completion Date

March 1, 2015

Completion Date

April 1, 2015

Last Updated

July 11, 2016

Enrollment

ACTUAL participants

Conditions

Primary Myelofibrosis (MF)

Interventions

Ruxolitinib

DRUG