Trial · NCT07096297
Luspatercept + Darbepoetin in MDS
NCT07096297, Phase 2, Recruiting, Yale University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Luspatercept + Darbepoetin in MDS. Trials, record NCT07096297. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07096297
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Luspatercept + Darbepoetin in MDS
- NCT number
- NCT07096297
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Yale University
- Conditions
- MDS (Myelodysplastic Syndrome)
- Interventions
- Luspatercept, Darbeopoetin
- First posted
- 2025-07-31
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07096297
GET https://conductscience.org/api/trials/v1/NCT07096297/registered