Trial · NCT03165734
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Spleen volume | From baseline at 24 weeks | To compare the efficacy of pacritinib with that of physician's choice (P/C) therapy, as assessed by the proportion of patients achieving a ≥35% spleen volume reduction (SVR) as measured by magnetic resonance imaging (MRI, preferred) or computed tomography (CT) scans |
| Primary | Total Symptom Score (TSS) (excluding tiredness) | From baseline at Week 24 | To compare the efficacy of pacritinib compared to P/C therapy, as assessed by the proportion of patients achieving a ≥50% reduction in Total Symptom Score (TSS). The TSS is the sum of the individual symptom scores for tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under ribs on the left side. Symptoms are ranked 0 (absent) to 10 (worst imaginable) |
| Secondary | Overall Survival (OS) | until 2.5 years after the date of randomization | To compare the overall survival (OS) of patients treated with pacritinib versus those treated with P/C |
| Secondary | Patient Global Impression of Change (PGIC) assessed at Week 24 | End of Week 12 to 2 years following Week 24 visit | To compare the percentage of patients who self-assess as "very much improved" or "much improved" as measured by the Patient Global Impression of Change (PGIC) in patients treated with pacritinib versus those treated with P/C |
| Secondary | To compare the safety of pacritinib versus P/C therapy | Randomization through 30 after last treatment | Safety will be assessed based on the incidence and severity (according to the Common Terminology Criteria for Adverse Events) of treatment emergent adverse events from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy. |
| Other | SVR of ≥35% | Up to 24 Weeks | Time to achievement of SVR of ≥35% |
| Other | Best response in SVR | At 24 Weeks | Best response in SVR by MRI or CT scan |
| Other | >25% SVR | From baseline and at Week 24 | Proportion of patients achieving \>25% SVR |
| Other | Red blood cell (RBC) | Baseline to End of Treatment | Achievement of red blood cell (RBC) transfusion independence at Weeks 12 and 24 |
| Other | hemoglobin level | Weeks 12 and 24 | Improvement in hemoglobin level without transfusion at Weeks 12 and 24 |
| Other | platelet count | Weeks 12 and 24 | Improvement in platelet count at Weeks 12 and 24 |
| Other | platelet transfusions | Weeks 12 and 24 | Frequency of platelet transfusions at Weeks 12 and 24 |
| Other | PROMIS | Baseline to Week 24 | Improvement in fatigue as measured by Patient-Reported Outcomes Measurement Information System (PROMIS) v.1.0 - Fatigue from Baseline through Week 24 |
| Other | Leukemia-free survival (LFS) | Baseline to Week 24 | Leukemia-free survival (LFS) of patients treated with pacritinib versus P/C therapy |
| Other | The percentage of red blood cell transfusion-independent patients achieving a 1 g/dL and a 2 g/dL increase in hemoglobin | Baseline to 24 weeks | The percentage of red blood cell transfusion-independent patients at baseline achieving a 1 g/dL and a 2 g/dL increase in hemoglobin at week 24 |
| Other | The percentage of platelet transfusion-independent patients with improvement in grade of thrombocytopenia | Baseline to 24 weeks | The percentage of platelet transfusion-independent patients at baseline with improvement in grade of thrombocytopenia at week 24 |
| Other | The percentage of transfusion-dependent patients achieving transfusion independence and achieving 50% reduction in transfusion rate | Baseline to 24 weeks | The percentage of transfusion-dependent patients at baseline achieving transfusion independence and achieving 50% reduction in transfusion rate at week 24 |
| Other | Hemoglobin A1c | Baseline to Week 24 | Changes in hemoglobin A1c |
| Other | mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers | Baseline to up to 24 Weeks | Changes in mutated allelic burden, gene expression, and pharmacodynamic (PD) biomarkers |
| Other | The proportion of patients who experience a major adverse cardiac event (MACE) | Baseline to up to 24 Weeks | MACE is a composite endpoint that is considered to occur if any of the following TEAEs occur: * cardiovascular death, defined as death due to acute myocardial infarction, sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular procedures, death due to cardiovascular hemorrhage, or death due to peripheral artery disease * non-fatal myocardial infarction * non-fatal stroke of any classification, including reversible focal neurological defects with imaging evidence of a new cerebral lesion consistent with ischemia or hemorrhage |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT03165734/registered