Myelofibrosis
Conditions
Brief summary
Overall survival (OS), defined as the time interval from randomization date to date of death from any cause.
Detailed description
Symptom response rate at Week 24 (defined as the proportion of patients who have ≥ 50% reduction in TSS at Week 24 from baseline as measured by the MFSAF v4.0), Progression-Free Survival, defined as the time interval from randomization date to the first date of disease progression (worsening splenomegaly or leukemic transformation per 2013 IWG-MRT criteria) or death from any cause, whichever occurs first., Spleen response rate at Week 24 (defined as the proportion of patients who achieve ≥ 35% reduction in spleen volume at Week 24 from baseline as measured by imaging scans). For additional secondary end points please refer to the study protocol.
Interventions
DRUG-
DRUGIMETELSTAT
Sponsors
Geron Corp.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS), defined as the time interval from randomization date to date of death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom response rate at Week 24 (defined as the proportion of patients who have ≥ 50% reduction in TSS at Week 24 from baseline as measured by the MFSAF v4.0), Progression-Free Survival, defined as the time interval from randomization date to the first date of disease progression (worsening splenomegaly or leukemic transformation per 2013 IWG-MRT criteria) or death from any cause, whichever occurs first., Spleen response rate at Week 24 (defined as the proportion of patients who achieve ≥ 35% reduction in spleen volume at Week 24 from baseline as measured by imaging scans). For additional secondary end points please refer to the study protocol. | — |
Countries
Austria, Belgium, Bulgaria, Denmark, France, Germany, Hungary, Italy, Poland, Portugal, Spain
Outcome results
None listed