safety and efficacy of ruxolitinib in anemic myelofibrosis patients
- Conditions
- treatment of anemic myelofibrosis patientsMedDRA version: 20.0 Level: LLT Classification code 10074692 Term: Post essential thrombocythaemia myelofibrosis System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10074691 Term: Post polycythaemia vera myelofibrosis System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-003552-75-AT
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the spleen length response rate at Week 24;<br> Secondary Objective: - To determine the spleen length response rate at Week 48<br> - To evaluate the effect of ruxolitinib on spleen length<br> - To evaluate the effect of ruxolitinib on symptoms<br> - To evaluate the effect of ruxolitinib on Patient Global Impression of Change (PGIC)<br> - To evaluate the effect of ruxolitinib on transfusion requirements<br> ;Primary end point(s): Proportion of patients achieving a 50% reduction in spleen length at Week 24;Timepoint(s) of evaluation of this end point: Week 24
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): - Proportion of patients achieving a 50% reduction in spleen length at week 48<br> - Percent change from baseline in spleen length over time<br> - Summary of the Modified MFSAF v2.0 and MF-7 over time<br> - PGIC at each visit where measured<br> - Summary of transfusions over time<br> ;<br> Timepoint(s) of evaluation of this end point: - Week 48<br> - Week 48<br> - Week 48<br> - Week 48<br> - Week 48<br>