Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis
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1. Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24) (Time Frame - At Week 24): Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.
Secondary outcome:
1. Percentage of Participants who achieve at least 50% Reduction in Total Symptom Score (TSS) (Time Frame - Baseline (Week 0) Up to Week 24): Reduction in TSS is measured by Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
2. Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at any time (Time Frame - Baseline (Week 0) Up to Week 97): Reduction in spleen volume is measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT), per International Working Group (IWG) criteria.
3. Percentage of Participants with Reduction in Grade of Bone Marrow Fibrosis (Time Frame - Baseline (Week 0) Up to Week 97): Reduction in grade of bone marrow fibrosis from baseline as measured by the European consensus grading system will be assessed.
4. Percentage of Participants with Anemia Response (Time Frame - Baseline (Week 0) Up to Week 97): Anemia response per International Working Group (IWG) criteria will be assessed.
5. Percentage of Participants with Overall Survival (Time Frame - Last Visit Up to 5 Years): Overall survival is defined as the time from start of study to the date of death from any cause.
6. Percentage of Participants with Leukemia-free Survival (Time Frame - Last Visit Up to 5 Years): Leukemia free survival is the time from start of study to the date of development of leukemia.
7. Percentage of Participants with Change in Fatigue (Time Frame - Baseline (Week 0) Up to Week 24): Change in fatigue will be assessed using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form (SF) 7a.
8. Time to Deterioration of Physical Functioning (Time Frame - Baseline (Week 0) Up to Week 97): Time to deterioration of physical functioning is measured by the physical functioning domain of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, or death.
9. Percentage of Participants with at Least 50% Reduction in TSS (Time Frame - Baseline (Week 0) Up to Week 97): At least 50% reduction in TSS from baseline (at any time) as measured by MFSAF v4.0.
Best Available Therapy (BAT): Tablet/Capsule; Oral or Solution for Subcutaneous Injection
Quelle: ClinicalTrials.gov
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"Study of Oral Navitoclax Tablet in Combination With Oral Ruxolitinib Tablet to Assess Change in Spleen Volume in Adult Participants With Relapsed/Refractory Myelofibrosis"
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