An Open-Label Clinical Trial of RVU120 as Monotherapy and in Combination with Ruxolitinib in Patients with Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61)

Conditions

Myelofibrosis

Brief summary

The proportion of participants achieving Spleen Volume Reduction (SVR) of ≥35% after 24 weeks of commencing study treatment by magnetic resonance imaging (MRI) or computed tomography (CT) scan

Detailed description

The proportion of participants achieving ≥1 Grade bone marrow fibrosis improvement after 24 weeks of commencing study treatment, Duration of Spleen Response assessed as time from initial SVR of ≥35% by MRI/CT until disease progression or death, whichever occurs first, Leukemic transformation as evidenced by bone marrow blast counts of at least 20%, or peripheral blast counts of at least 20% lasting 2 weeks, Hematologic (clinical) improvement as defined by International Working Group (IWG) Consensus Criteria 2006, Progression-Free Survival, Overall Survival, Incidence and severity of adverse events (AEs), PK of RVU120 including Cmax, tmax, AUCtau, and AUCinf, and t½, The proportion of participants achieving at least a 50% reduction in Total Symptom Score (TSS) after 24 weeks of commencing study treatment, For all participants, assessment of the absolute change in TSS from baseline

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Interventions

DRUGJakavi 15 mg tablets

DRUGJakavi 20 mg tablets

DRUGJakavi 5 mg tablets

DRUGSEL120 monohydrochloride

DRUGJakavi 10 mg tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of participants achieving Spleen Volume Reduction (SVR) of ≥35% after 24 weeks of commencing study treatment by magnetic resonance imaging (MRI) or computed tomography (CT) scan	—

Secondary

Measure	Time frame
The proportion of participants achieving ≥1 Grade bone marrow fibrosis improvement after 24 weeks of commencing study treatment, Duration of Spleen Response assessed as time from initial SVR of ≥35% by MRI/CT until disease progression or death, whichever occurs first, Leukemic transformation as evidenced by bone marrow blast counts of at least 20%, or peripheral blast counts of at least 20% lasting 2 weeks, Hematologic (clinical) improvement as defined by International Working Group (IWG) Consensus Criteria 2006, Progression-Free Survival, Overall Survival, Incidence and severity of adverse events (AEs), PK of RVU120 including Cmax, tmax, AUCtau, and AUCinf, and t½, The proportion of participants achieving at least a 50% reduction in Total Symptom Score (TSS) after 24 weeks of commencing study treatment, For all participants, assessment of the absolute change in TSS from baseline	—

Measure

Time frame

The proportion of participants achieving ≥1 Grade bone marrow fibrosis improvement after 24 weeks of commencing study treatment, Duration of Spleen Response assessed as time from initial SVR of ≥35% by MRI/CT until disease progression or death, whichever occurs first, Leukemic transformation as evidenced by bone marrow blast counts of at least 20%, or peripheral blast counts of at least 20% lasting 2 weeks, Hematologic (clinical) improvement as defined by International Working Group (IWG) Consensus Criteria 2006, Progression-Free Survival, Overall Survival, Incidence and severity of adverse events (AEs), PK of RVU120 including Cmax, tmax, AUCtau, and AUCinf, and t½, The proportion of participants achieving at least a 50% reduction in Total Symptom Score (TSS) after 24 weeks of commencing study treatment, For all participants, assessment of the absolute change in TSS from baseline

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Countries

Italy, Poland

Outcome results

None listed