Trial · NCT07357727
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline total symptom score (TSS) ≥ 25 | Week 24 | Spleen Response (SVR35) is defined as achieving a reduction of at least 35 percent in spleen volume from baseline to Week 24, as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and assessed by a centralized radiology review in participants with baseline TSS ≥ 25. |
| Primary | Absolute change from baseline in total symptom score (TSS) at Week 24 in participants with baseline TSS ≥ 25 | Baseline, Week 24 | Symptom improvement at Week 24 is defined as the absolute change from baseline in the total symptom score (TSS) at Week 24, as measured by the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) in participants with baseline TSS ≥ 25. |
| Primary | Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline TSS ≥ 15 | Week 24 | Spleen Response (SVR35) is defined as achieving a reduction of at least 35 percent in spleen volume from baseline to Week 24, as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and assessed by a centralized radiology review in participants with baseline TSS ≥ 15. |
| Primary | Absolute change from baseline in total symptom score (TSS) at Week 24 in participants with baseline TSS ≥ 15 | Baseline, Week 24 | Symptom improvement at Week 24 is defined as the absolute change from baseline in the total symptom score (TSS) at Week 24, as measured by the Myelofibrosis Symptom Assessment Form version 4.0 (MFSAF v4.0) in participants with baseline TSS ≥ 15. |
| Secondary | Number of Participants with Splenic Response (SVR35) by Central Radiology Reads over time | Week 12, Week 36, Week 48 and every 12 weeks thereafter till End of Study (an average of 3 years) | Spleen Response (SVR35) over time is defined as achieving a reduction of at least 35 percent in spleen volume from baseline to Week 12, Week 36, Week 48 and thereafter, as measured by magnetic resonance imaging (MRI) or computed tomography (CT) scan, and assessed by a centralized radiology review. |
| Secondary | Absolute change from baseline and percentage change from baseline in spleen volume over time | Baseline, Week 12, Week 24, Week 36, Week 48, and every 12 weeks thereafter till End of Study (an average of 3 years) | Absolute and percentage change from baseline in spleen volume over time will be summarized using descriptive summary statistics |
| Secondary | Time to first SVR35 response | From date of randomization to the date of first SVR35 response, assessed up to approximately 3 years | Time to first SVR35 response defined as the time from date of randomization to the date of first SVR35 response as measured by MRI (or CT scan) will be summarized by treatment arm. |
| Secondary | Duration of first SVR35 response | From first SVR35 response to loss of response, assessed up to approximately 3 years | Duration of first SVR35 response defined as the time from first SVR35 response to loss of response for any participant who reaches SVR35 at any time. |
| Secondary | Number of Participants with TSS50 response at Week 24 | Week 24 | Symptom response defined as achieving ≥ 50% reduction in total symptom score (TSS50) from baseline to Week 24 as measured by the MFSAF v4.0 |
| Secondary | Number of Participants with TSS50 response over time | Baseline, Week 12, Week 24, Week 36, Week 48, and every 12 weeks thereafter till End of Study (an average of 3 years) | Symptom response defined as achieving ≥ 50% reduction in total symptom score (TSS50) from baseline to Week 12, Week 36, Week 48 and thereafter as measured by the MFSAF v4.0 |
| Secondary | Absolute and percentage change from baseline in TSS over time | Baseline, Week 12, Week 24, Week 36, Week 48, and every 12 weeks thereafter till End of Study (an average of 3 years) | Absolute change from baseline and percentage change from baseline in TSS over time |
| Secondary | Time to first TSS50 response | From date of randomization till date of first TSS50 response, assessed up to approximately 3 years | Time to first TSS50 response defined as the time from date of randomization to the date of first TSS50 response as measured by the MFSAF v4.0. |
| Secondary | Duration of TSS50 response | From first TSS50 response to loss of response, assessed up to approximately 3 years | Duration of TSS50 response defined as the time from first TSS50 response to loss of response for any participant who reaches TSS50 at any time. |
| Secondary | Dual Response (SVR35 + TSS50) | Baseline, Week 12, Week 24, Week 36, Week 48, and every 12 weeks thereafter till End of Study (an average of 3 years) | Dual response is defined as achieving both ≥ 35% reduction in spleen volume (SVR35) and ≥ 50% reduction in total symptom score (TSS50) from baseline to Week 12, 24, 36, 48 and every 12 weeks thereafter, with SVR measured by MRI (or CT scan) and assessed by central radiology read and TSS measured by MFSAF v4.0. |
| Secondary | Hemoglobin response | 12 consecutive weeks (rolling window) up to 7 days following last dose of pelabresib/placebo | Hemoglobin response defined as a ≥1.5 g/dL average increase in hemoglobin from baseline in any 12-week mean hemoglobin concentration. |
| Secondary | Change from baseline in hemoglobin over time | Up to 7 days following last dose of pelabresib/placebo | Change from baseline in hemoglobin over time will be summarized using descriptive summary statistics. |
| Secondary | Anemia response over time | Up to 7 days following last dose of pelabresib/placebo | Anemia response (major response, minor response, stable anemia, progressive anemia) as per proposed 2024 IWG-ELN criteria in participants with transfusion dependent and non-transfusion dependent anemia (Tefferi et al 2024). |
| Secondary | Overall survival (OS) | From date of randomization till date of death due to any cause, assessed up to approximately 3 years | Overall survival (OS) defined as the time from date of randomization to date of death due to any cause. |
| Secondary | Progression-free survival (PFS) | From date of randomization till date of documented disease progression, or death due to any cause whichever comes first, assessed up to approximately 3 years | Progression-free survival (PFS) defined as the time from date of randomization to date of documented disease progression, or death due to any cause whichever comes first. |
| Secondary | Leukemia-free survival (LFS) | From date of randomization till date of leukemic transformation, or death due to any cause whichever comes first, assessed up to approximately 3 years | Leukemia-free survival (LFS) is defined as the time from date of randomization to date of leukemic transformation, or death due to any cause whichever comes first. |
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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