A phase 2 study of Ruxolitinib in patients with splanchnic vein thrombosis associated with myeloproliferative neoplasm

• Conditions: splanchnic vein thrombosis associated with myeloproliferative neoplasm; MedDRA version: 15.0Level: LLTClassification code 10013238Term: Disorder myeloproliferativeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2012-002253-30-IT
• Lead Sponsor: IVERSITA' DEGLI STUDI DI FIRENZE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-31
• Last Update Posted: 3 February 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Study patient population is represented by male or female subjects with splanchnic vein thrombosis (SVT) (including Budd-Chiari syndrome, mesenteric vein thrombosis, portal vein thrombosis, splenic vein thrombosis) in the setting of myeloproliferative neoplasms, ie polycythemia vera (PV), essential thrombocythemia (ET) (according to the WHO criteria), or myelofibrosis both primary (PMF) and secondary to polycythemia vera (PPV-MF) or essential thrombocythemia (PET-MF) (according to the WHO and IWG-MRT criteria, respectively), either JAK2V617F positive or negative, MPLW515L/K positive or negative, who are equal to or older than 18 and have a palpable spleen greater than 5 cm from the costal margin to the point of greatest splenic protrusion, with a platelet count >100x109/L and normal liver function.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11

Exclusion Criteria

1.ALT or AST > 2.5 x ULN 2.Total bilirubin >2xULN 3.Active acute or chronic hepatitis A, B or C (Appendix III) 4.Presence of refractory ascites. 5.Presence of esophageal varices greater than grade 2 and/or a history of previous recurrent bleedings from varices, ie more than two episodes in the last 12 months. 6.Presence of TIPS (transjugular portosystemic shunt). 7.Creatinine level not greater than 1.5-fold the upper limit. 8.Other neoplastic disorders unless at least 3 years before and in complete remission except for treated, early-stage squamous or basal cell carcinoma of the skin. 9.Patient has hypersensitivity to Ruxolitinib or any of the eccipients. 10.Subjects with a life expectancy of less than 6 months 11.Subjects with inadequate bone marrow reserve as demonstrated by: •Absolute neutrophil count (ANC) that is = 1x109/L •Platelet count that is < 100x109/L without the assistance of growth factors, thrombopoietic factors or platelet transfusions. 12.Patient has a percentage of blast cell in peripheral blood greater than 5% within 14 days before enrollment. 13.Subjects with any history of platelet counts < 50x109/L or ANC < 0.5x109/L except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason. 14.Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy, except for antiviral prophylaxis: subjects with acute bacterial infections requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed. 15.Subjects HIV-positive. 16.Patients undergoing treatment with hematopoietic growth factor receptor-agonists (i.e., erythropoietin [Epo], granulocyte colony stimulating factor (GCSF, romiplostim, eltrombopag) at any time within 2 weeks prior to Screening or 4 weeks prior to baseline. 17.Patients receiving any medications listed in the prohibited medications” listing 18.Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC424 (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection). 19.Patients receiving ongoing treatment with another investigational medication or having been treated with an investigational medication within 30 days of study drug treatment. 20.Patient is currently eligible, has the option, and is willing to undergo stem cell transplantation. 21.Serious medical or psychiatric illness likely to interfere with participation in this clinical study. 22.Subjects with cardiac disease which in the Investigator’s opinion may jeopardize the safety of the subject or the compliance with the protocol. 23.Subjects with currently uncontrolled or unstable angina. 24.Subjects with currently rapid or paroxysmal atrial fibrillation. 25.Subjects who have had splenic irradiation within 12 months prior to Screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified