Status:
COMPLETED
Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Myelofibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This was an open label, randomized study comparing the efficacy and safety of randomized 2:1 Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The purpose was to comp...
Detailed Description
This study included a randomized treatment phase, followed by an extension phase. The treatment phase lasted from Study Day 1 (day of randomization) to the occurrence of a protocol-specified progressi...
Eligibility Criteria
Inclusion
- Subjects must be diagnosed with PMF, PPV-MF or PET-MF according to the 2008 World Health Organization criteria
- Subjects with MF requiring therapy must be classified as high risk OR intermediate risk level 2 according to the prognostic factors defined by the International Working Group
- Subjects with an ECOG performance status of 0, 1, 2 or 3
- Subjects with peripheral blood blast count of \< 10%.
- Subjects who have not previously received treatment with a JAK inhibitor
Exclusion
- Subjects with a life expectancy of less than 6 months
- Subjects with inadequate bone marrow reserve as demonstrated by specific clinical laboratory counts
- Subjects with any history of platelet counts \< 50,000/µL or ANC \< 500/µL except during treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for any other reason
- Subjects with inadequate liver or renal function
- Subjects with clinically significant bacterial, fungal, parasitic or viral infection which require therapy
- Subjects with an active malignancy over the previous 5 years except specific skin cancers
- Subjects with severe cardiac conditions
- Subjects who have had splenic irradiation within 12 months
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2015
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00934544
Start Date
July 1 2009
End Date
March 4 2015
Last Update
August 19 2019
Active Locations (61)
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1
Novartis Investigative Site
Innsbruck, Austria, 6020
2
Novartis Investigative Site
Linz, Austria, 4010
3
Novartis Investigative Site
Salzburg, Austria, 5020
4
Novartis Investigative Site
Vienna, Austria, A-1090