EUCTR2016-003552-75-ATActive, not recruitingPhase 1
A multicenter phase II, open label, single arm study to evaluate the efficacy and safety of ruxolitinib in the treatment of anemic myelofibrosis patients - REALISE
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 50
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •- Male or female patients aged = 18 years of age.
- •- Patients must be diagnosed with PMF, according to the 2016 revised International Standard Criteria (Arber et al, 2016), PPV MF or PET-MF (Barosi 2008), irrespective of JAK2 mutation status.
- •- Patients with palpable splenomegaly that is equal to or greater than 5 cm below the left costal margin.
- •- Patients with a hemoglobin less than 10 g/dL
- •- Patients with a history of transfusions must have a documented transfusion record in the previous 12 weeks to baseline.
- •- Patients with a peripheral blood blast percentage count of < 10%.
- •Additional inclusion criteria as per full protocol may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
- •- Patients with prior treatment with any JAK1 or JAK2 inhibitor.
- •- Patients with inadequate bone marrow reserve at baseline visit asdemonstrated by at least one of the following:
- •? ANC that is = 1,000/µL.
- •? Platelet count that is <50,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
- •? Hemoglobin count that is = 6.5 g/dL despite transfusions.
- •- Patients with severely impaired renal function
- •- Patients with inadequate liver function
- •- Patients being treated concurrently with a strong (potent) systemic inhibitor or inducer of CYP3A4 at the time of Screening
- •- Acute viral hepatitis or active chronic hepatitis B or C infection.
- •- History of progressive multifocal leuko-encephalopathy (PML)
- •Additional exclusion criteria as per full protocol may apply.
Investigators
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