Luspatercept + Darbepoetin in MDS

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07096297
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • MDS (Myelodysplastic Syndrome)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Luspatercept — DRUG
    Luspatercept will be administered every 3 weeks (21 days) at a starting dose of 1.0 mg/kg (Dose Level 0). Luspatercept will be administered to participants by the study staff at the clinical site and administration will be documented in the participant's source record. Participants must have Hgb, blood pressure and weight assessed (changes of body weight of ≤ ± 5% do not require a dose adjustment) prior to each luspatercept dose administration. Subcutaneous injections will be given in the upper arm, thigh, and/or abdomen. Volume for subcutaneous injection will be per institutional standard/guidelines.
  • Darbeopoetin — DRUG
    Darbepoetin alfa will be administered every 3 weeks (21 days), at a starting dose of 300 ug (Dose Level 0). Darbepoetin alfa will be administered to participants by the study staff at the clinical site and administration will be documented in the participant's source record. Darbepoetin alfa will be administered as a subcutaneous injection by the site staff in the upper arm, thigh, and/or abdomen per institutional standard/guidelines.

Study Details

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.

Key Dates

Start date
Dec 16, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Luspatercept + Darbepoetin
    Each participant will be treated with luspatercept every 21 days (three weeks) in combination with darbepoetin alfa every 21 days (three weeks). Both agents will be administered on day 1 of each 21-day cycle. Based on the individual participant's response to combination therapy of luspatercept and darbepoetin alfa, the doses of luspatercept and/or darbepoetin alfa can be either decreased or increased. The starting dose is luspatercept at 1.0 mg/kg (Dose Level 0) and darbepoetin alfa 300 µg (Dose Level 0).

Primary Outcome Measure

Mean Rate of Red Blood Cell Transfusion Independence [ Time Frame: 24 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Farah Fasihuddin
[email protected]
203-494-4610
Maximilian Stahl, MD (PRINCIPAL_INVESTIGATOR)
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicagoIllinois60611
Elizabeth Morrin
[email protected]
3126951331
Yasmin M Abaza, MD (PRINCIPAL_INVESTIGATOR)
Harold C. Simmons Comprehensive Cancer Center of UT SouthwesternDallasTexas75235
Michael Mccane
[email protected]
2146486553
Yazan Madanat, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Yale University· New Haven, CTRobert H. Lurie Comprehensive Cancer Center of Northwestern University· Chicago, ILHarold C. Simmons Comprehensive Cancer Center of UT Southwestern· Dallas, TX

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