Phase 3
N=219
Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial
Myelofibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00934544 ↗Enrolled (actual)
219
Serious AEs
43.4%
Results posted
May 2012
Primary outcome: Primary: Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 — 28.5; 0 Percentage of Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ruxolitinib (Drug); Best Available Therapy (BAT) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 48 |
28.5; 0 | <0.0001 sig |
| SECONDARY Duration of Maintenance of Spleen Volume Reduction (Median) |
3.22; NA | — |
| SECONDARY Duration of Maintenance of Spleen Volume Reduction (Kaplan-Meier Estimates) |
0.72; NA; 0.67; NA; 0.63; NA | — |
| SECONDARY Percentage of Participants With at Least 35% Reduction in Spleen Volume From Baseline at Week 24 |
31.9; 0 | — |
| SECONDARY Time to First at Least 35% Reduction in Spleen Volume From Baseline by Treatment (Primary Analysis) |
0.23; 0; 0.67; 1; 0.87; 1 | — |
| SECONDARY Progression-free Survival (PFS) |
1.6; 1.4 | — |
| SECONDARY Leukemia-free Survival (LFS) |
NA; 4.1 | — |
| SECONDARY Overall Survival (OS) |
NA; 4.1 | — |
| SECONDARY Percentage of Participants With Bone Marrow Histomorphology at Week 48 (Primary Analysis) |
2.7; 0.0; 7.5; 2.7; 8.9; 6.8 | — |
| SECONDARY Bone Marrow Histomorphology |
1; 1; 2; 1; 2; 0 | — |
| SECONDARY Duration of Follow-up by Treatment |
16; 15; 21; 10; 9; 13 | — |
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 compare the efficacy, safety and tolerability of Ruxolitinib (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential thrombocythemia myelofibrosis (PET-MF).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00934544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.