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Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions

NCT05384691 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2024-01-31

No results posted yet for this study

Summary

Anemia in patients with very low, low or intermediate risk myelodysplastic syndromes (MDS), that are non-transfusion dependent

Conditions

Interventions

DRUG

Luspatercept Injection

All formally included patients will receive 1.75 mg/kg luspatercept administered subcutaneously every three weeks (on day 1 of each 21-day cycle) for a duration of 24 weeks. Responders at the response assessment (according to HI-E) in week 25 will be further treated with 1.75 mg/kg luspatercept until loss of response for an expected maximum of 18 months.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Anne Sophie Kubasch, Dr. · University Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2026-07-31
Completion
2027-07-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384691 on ClinicalTrials.gov