Phase 3
N=309
COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment: The COMFORT-I Trial
MPN (Myeloproliferative Neoplasms)
Bottom Line
View on ClinicalTrials.gov: NCT00952289 ↗Enrolled (actual)
309
Serious AEs
31.4%
Results posted
Jan 2012
Primary outcome: Primary: Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 — 65; 1 participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ruxolitinib (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving ≥ 35% Reduction in Spleen Volume From Baseline to Week 24 |
65; 1 | <0.0001 sig |
| SECONDARY Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib |
0.76; 0.67; 0.27 | — |
| SECONDARY Duration of Maintenance of a ≥ 35% Reduction From Baseline in Spleen Volume Among Patients Initially Randomized to Receive Ruxolitinib |
135.0 | — |
| SECONDARY Number of Participants With a ≥ 50% Reduction in Total Symptom Score From Baseline to Week 24 |
68; 8 | — |
| SECONDARY Change From Baseline to Week 24 in Total Symptom Score |
18.0; 16.5; 9.4; 19.7; -8.6; 3.2 | — |
| SECONDARY Overall Survival |
10; 14; 145; 140 | — |
| SECONDARY Overall Survival Time |
NA; NA | — |
| SECONDARY Overall Survival - Extended Data |
13; 24; 142; 130 | — |
| SECONDARY Overall Survival Time - Extended Data |
NA; NA | — |
| SECONDARY Overall Survival at Week 144 |
42; 54; 113; 100 | — |
| SECONDARY Overall Survival Time at Week 144 |
0.74; 0.61 | — |
Summary
This was a randomized, double-blind study comparing the efficacy and safety of ruxolitinib (INCB018424) tablets to matching placebo tablets in patients diagnosed with Myelofibrosis (either Primary Myelofibrosis (PMF) or Post-Polycythemia Vera Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF).
Eligibility Criteria
Inclusion Criteria
- Subjects must be diagnosed with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) or post-essential thrombocythemia-myelofibrosis (PET-MF) according to the 2008 World Health Organization criteria
- Subjects with myelofibrosis 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3
- Subjects who have not previously received treatment with a Janus kinase (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 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 (NCT00952289). 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.