Trial · NCT07096297
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Rate of Red Blood Cell Transfusion Independence | 24 weeks | Mean rate of red blood cell transfusion independence (RBC-TI) for at least any consecutive 84 days (≥ 12 consecutive weeks) during weeks 1-24 compared to baseline in non-mutated SF3B1, lower-risk myelodysplastic syndrome patients treated with Luspatercept plus Darbepoetin Alfa |
| Primary | Mean Rate of Hemoglobin Increase | 24 weeks | Mean rate of hemoglobin ≥ 1.5 g/dL during weeks 1-24 compared to baseline in non-mutated SF3B1, lower-risk myelodysplastic syndrome patients treated with Luspatercept plus Darbepoetin Alfa. |
| Secondary | Mean rate of Red Blood Cell Transfusion Independence for ≥8 Consecutive Weeks During Weeks 1-24 | 24 weeks | Mean rate of red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks during weeks 1-24 compared to baseline. Assessed as the proportion of participants who achieve RBC-TI within the first 24 weeks of the study. |
| Secondary | Mean rate of Red Blood Cell Transfusion Independence for ≥8 Consecutive Weeks During Weeks 1-48 | 48 weeks | Mean rate of red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks during weeks 1-48 compared to baseline. Assessed as the proportion of participants who achieve RBC-TI within the first 48 weeks of the study. |
| Secondary | Mean rate of Red Blood Cell Transfusion Independence for ≥12 Consecutive Weeks During Weeks 1-24 | 24 weeks | Mean rate of red blood cell transfusion independence (RBC-TI) for at least 12 consecutive weeks during weeks 1-24 compared to baseline. Assessed as the proportion of participants who achieve RBC-TI within the first 24 weeks of the study. |
| Secondary | Mean rate of Red Blood Cell Transfusion Independence for ≥12 Consecutive Weeks During Weeks 1-48 | 48 weeks | Mean rate of red blood cell transfusion independence (RBC-TI) for at least 12 consecutive weeks during weeks 1-48 compared to baseline. Assessed as the proportion of participants who achieve RBC-TI within the first 48 weeks of the study. |
| Secondary | Mean rate of Red Blood Cell Transfusion Independence for ≥24 Consecutive Weeks During Weeks 1-24 | 24 weeks | Mean rate of red blood cell transfusion independence (RBC-TI) for at least 24 consecutive weeks during weeks 1-24 compared to baseline. Assessed as the proportion of participants who achieve RBC-TI within the first 24 weeks of the study. |
| Secondary | Mean rate of Red Blood Cell Transfusion Independence for ≥24 Consecutive Weeks During Weeks 1-48 | 48 weeks | Mean rate of red blood cell transfusion independence (RBC-TI) for at least 24 consecutive weeks during weeks 1-48 compared to baseline. Assessed as the proportion of participants who achieve RBC-TI within the first 48 weeks of the study. |
| Secondary | Duration of Red Blood Cell Transfusion Independence for ≥8 Weeks | Assessed throughout the entire study period, approximately 2.5 years | To determine the duration of red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks. This outcome measure will evaluate how long participants maintain RBC-TI for a minimum of 8 weeks during the study period. |
| Secondary | Duration of Red Blood Cell Transfusion Independence for ≥12 Weeks | Assessed throughout the entire study period, approximately 2.5 years | Duration of red blood cell transfusion independence (RBC-TI) for at least 12 consecutive weeks. Assessed as how long participants maintain RBC-TI for a minimum of 12 weeks during the study period. |
| Secondary | Duration of Red Blood Cell Transfusion Independence for ≥24 Weeks | Assessed throughout the entire study period, approximately 2.5 years | To determine the duration of red blood cell transfusion independence (RBC-TI) for at least 24 consecutive weeks. Assessed as how long participants maintain RBC-TI for a minimum of 24 weeks during the study period. |
| Secondary | Median Time to Red Blood Cell Transfusion Independence for ≥8 Consecutive Weeks | Assessed throughout the entire study period, approximately 2.5 years | Median time to achieve red blood cell transfusion independence (RBC-TI) for at least 8 consecutive weeks. Assessed as the median duration of time it takes for participants to achieve RBC-TI for a minimum of 8 weeks during the study period. |
| Secondary | Median Time to Red Blood Cell Transfusion Independence for ≥12 Consecutive Weeks | Assessed throughout the entire study period, approximately 2.5 years | Median time to achieve red blood cell transfusion independence (RBC-TI) for at least 12 consecutive weeks. Assessed as the median duration of time it takes for participants to achieve RBC-TI for a minimum of 12 weeks during the study period. |
| Secondary | Median Time to Red Blood Cell Transfusion Independence for ≥24 Consecutive Weeks | Assessed throughout the entire study period, approximately 2.5 years | Median time to achieve red blood cell transfusion independence (RBC-TI) for at least 24 consecutive weeks. Assessed as the median duration of time it takes for participants to achieve RBC-TI for a minimum of 24 weeks during the study period. |
| Secondary | Mean rate of Hematological Improvement Based on MDS 2018 IWG Response Criteria | Assessed throughout the entire study period, approximately 2.5 years | Mean rate of hematological improvement (HI) in participants as defined by the Myelodysplastic Syndromes (MDS) 2018 International Working Group (IWG) response criteria. |
| Secondary | Changes in Health-Related Quality of Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | At baseline, every 21 days during the treatment period, during the 24 week response assessment (approximately 169 days after beginning study treatment), at the end of treatment visit and during the 42 day follow up visit | Health-related quality of life (HRQoL) will be assessed using the EORTC QLQ-C30. This outcome measure will evaluate participants' overall quality of life, functional status, and symptom burden at various time points throughout the study. Scoring Range: 0 to 100 for each scale. Functioning Scales: Higher scores = better functioning. Symptom Scales: Higher scores = worse symptoms. Global Health Status/QOL Scale: Higher scores = better overall QOL. |
| Secondary | Changes in Anemia Outcome Measures Using the Functional Assessment of Cancer Therapy - Anemia (FACT-An) Questionnaire | At baseline, every 21 days during the treatment period, during the 24 week response assessment (approximately 169 days after beginning study treatment), at the end of treatment visit and during the 42 day follow up visit | Changes in anemia-related quality of life using the FACT-An questionnaire. This outcome measure will evaluate the impact of anemia on participants' well-being, including physical, social, and emotional functioning, at various time points throughout the study. Scoring Range: 0 to 188 total. Higher scores=better QOL. |
| Secondary | Changes in Quality of Life Using the Quality of Life in Myelodysplasia Scale (QUALMS-P) Questionnaire | At baseline, every 21 days during the treatment period, during the 24 week response assessment (approximately 169 days after beginning study treatment), at the end of treatment visit and during the 42 day follow up visit | Changes in quality of life specific to myelodysplasia using the QUALMS-P questionnaire. This outcome measure will evaluate the effects of myelodysplasia on participants' day-to-day life and overall well-being at various time points throughout the study. Total score 0-100. Higher scores=better QOL. |
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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