Trial · NCT07447817
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in spleen volume | Baseline and 24 weeks | Evaluate clinical efficacy of pacritinib and selinexor in myelofibrosis patients who are JAK inhibitor-naïve and have anemia and thrombocytopenia by assessing spleen volume reduction (SVR) of 35% or greater compared to baseline as measured by imaging (MRI/CT) |
| Secondary | Spleen response rate | At 24 weeks and 48 weeks | Spleen response rate (by palpation) after 6 and 12 cycles; spleen response is defined as baseline splenomegaly palpable at 5-10cm that becomes not palpable, or baseline splenomegaly of \>10cm that decreases by ≥ 50%, as measured by palpation |
| Secondary | Change in the Myelofibrosis-Symptom Assessment Form Total Symptom Score (MF-SAF TSS) | At 24 weeks and 48 weeks | Evaluate change in patient reported outcomes of treatment Change in MF-SAF TSS from baseline after 6 and 12 cycles; symptom response will be determined in participants with baseline MF-SAF TSS ≥ 10. The MF-SAF TSS comprises 7 items measuring MF-related symptoms. Each item is scored on a scale ranging from 0 (absent) to 10 (worst imaginable) and the items are summed for a total score. The Mf-SAF TSS is the summation of all the individual scores (0-70 scale). Symptoms response requires ≥50% reduction in the MPN-SAF TSS and will be evaluable only in patients with a baseline TSS \>= 10. |
| Secondary | Change in Patient Global Impression of Change (PGIC) | At 24 weeks and 48 weeks | Patient Global Impression of Change (PGIC) response after 6 and 12 cycles; PGIC response is defined as "minimally improved" or better The Patient Global Impression of Change (PGIC) will be used to assess self-reported belief about the efficacy of treatment. PGIC is a 7-point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved", "much improved", "minimally improved", "no change", "minimally worse", "much worse", or "very much worse. Total scale from 1-7, with higher score indicating poorer health outcomes. |
| Secondary | Anemia response | At 24 weeks and 48 weeks | Anemia response after 6 and 12 cycles; anemia response is determined according to revised 2024 International Working Group-European LeukemiaNet (IWG-ELN) criteria and includes major response rate and minor response rate for transfusion-dependent anemia. Major response: No transfusions for 12 weeks alongside a 12-week average hemoglobin increase of 150g/L Minor response: A 50% or more reduction in transfusions and failure to meet major response thresholds. |
| Secondary | Change in hemoglobin level | Continuously across all cycles of treatment, up to 48 weeks | Hemoglobin is the protein molecule in red blood cells that carries oxygen from the lungs to the body's tissues and returns carbon dioxide from the tissues back to the lungs. |
| Secondary | Change in platelet count | Continuously across all cycles of treatment, up to 48 weeks | Platelets are part of the blood cells. Platelets are a part of the blood clotting system and help in preventing bleeding. |
| Secondary | Progression-free survival | At time of disease progression or at 48 weeks, whichever occurs first | Progression-free survival (PFS) is defined as time from first treatment to disease progression by IWG-ELN criteria |
| Secondary | Overall survival | At time of death or censored at last follow-up, at 48 weeks | Overall survival (OS) is defined as time from first treatment to death due to any cause or censored at last follow-up |
| Secondary | Number of participants achieving RBC transfusion independence) | at 24 weeks and at 48 weeks | The number of participants achieving transfusion independence will be divided by the number of participants who were transfusion-dependent at baseline |
| Secondary | Number of participants achieving platelet transfusion independence | at 24 weeks and at 48 weeks | The number of participants achieving transfusion independence will be divided by the number of participants who were transfusion-dependent at baseline |
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.
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GET https://conductscience.org/api/trials/v1/NCT07447817/registered