Status:
COMPLETED
Alternative Dosing Strategy of Ruxolitinib in Patients With Myelofibrosis
Lead Sponsor:
Incyte Corporation
Conditions:
Primary Myelofibrosis
Post-Polycythemia Vera Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the effect of an alternative dosing strategy of ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) and po...
Detailed Description
This pilot study was designed to explore an alternative dosing approach with the purpose of reducing anemia and thrombocytopenia. Subjects began dosing at 10 mg bid and had the opportunity for dose in...
Eligibility Criteria
Inclusion
- Diagnosis of Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) as confirmed by bone marrow biopsy.
- Must score at least 2 points on the Dynamic International Prognostic Scoring System (DIPSS) scale for prognostic risk factors.
- Peripheral blast count \< 5% at both Screening and Baseline hematology assessments.
- Must discontinue all drugs used to treat underlying myelofibrosis (MF) disease no later than Day -1 (the day prior to starting ruxolitinib).
- Must have hemoglobin value ≥ 6.5 g/dL and be willing to receive blood transfusions.
- Platelet count ≥ 100\*10\^9/L.
- Must have a palpable spleen.
Exclusion
- Inadequate liver or bone marrow reserves, end stage renal disease on dialysis, clinically significant concurrent infections requiring therapy, or unstable cardiac function.
- Invasive malignancies over the previous 5 years (except treated early stage carcinomas of the skin, completely resected intraepithelial carcinoma of the cervix, and completely resected papillary thyroid and follicular thyroid cancers).
- Splenic irradiation within 6 months prior to receiving the first dose of study medication.
- Life expectancy less than 6 months.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01445769
Start Date
September 1 2011
End Date
April 1 2013
Last Update
March 27 2019
Active Locations (21)
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1
Highland, California, United States
2
La Jolla, California, United States
3
Los Angeles, California, United States
4
Jacksonville, Florida, United States