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NCT07096297 · ClinicalTrials.gov registry record · Phase 2

Luspatercept + Darbepoetin in MDS

A Phase 2 study of MDS (Myelodysplastic Syndrome), sponsored by Yale University.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
3
Study locations

NCT07096297: Recruiting Phase 2 study of MDS (Myelodysplastic Syndrome), sponsored by Yale University.

NCT07096297 is a Phase 2 study of MDS (Myelodysplastic Syndrome) that is actively recruiting participants, run by Yale University. The registered enrollment target is 60 participants, below the 113-participant average among 6 other MDS (Myelodysplastic Syndrome) trials with a reported enrollment target (47% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07096297, a Phase 2 study of MDS (Myelodysplastic Syndrome), is actively recruiting participants, sponsored by Yale University.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
3
Study locations

Study Summary

This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.

Primary Outcome

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

Conditions Studied

MDS (Myelodysplastic Syndrome)

Interventions

  • DRUG Luspatercept
  • DRUG Darbeopoetin

Study Locations (3)

Connecticut

  • Yale University - New Haven

Illinois

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago

Texas

  • Harold C. Simmons Comprehensive Cancer Center of UT Southwestern - Dallas

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-12-16
Est. Completion 2030-08
Phase Phase 2
Yale University

1,492 total trials

What NCT07096297 shows while recruiting

NCT07096297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 113-participant average among 6 other MDS (Myelodysplastic Syndrome) trials with a reported enrollment target (47% lower).

The record links to 1 condition, with MDS (Myelodysplastic Syndrome) appearing as the primary indexed condition, and to 2 interventions - of which Luspatercept is the first listed.

NCT07096297 reports a single indexed study location in Connecticut, Illinois, Texas.

Frequently Asked Questions

What is clinical trial NCT07096297 about?

NCT07096297 is a clinical study titled "Luspatercept + Darbepoetin in MDS". This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.

What is the current status of trial NCT07096297?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-12-16. Estimated completion is 2030-08.

What conditions does trial NCT07096297 study?

This clinical trial studies the following conditions: MDS (Myelodysplastic Syndrome).

What interventions are being tested in trial NCT07096297?

The interventions under investigation include: Luspatercept (DRUG), Darbeopoetin (DRUG).

Who is sponsoring clinical trial NCT07096297?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07096297 being conducted?

This trial has 3 study locations across Connecticut, Illinois, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT07096297

Source: ClinicalTrials.gov NCT07096297, the US trial registry maintained by the National Library of Medicine. NCT07096297 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.