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Assessment of Effectiveness and Safety of Luspatercept in Patients Suffering From Lower-risk Myelodysplastic Syndrome.

NCT05181592 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-09-30

No results posted yet for this study

Summary

A phase IIIb, open-label, single arm study to evaluate the efficacy and safety of luspatercept in patients with lower-risk MDS and ring-sideroblastic phenotype (MDS-RS)

Conditions

Interventions

DRUG

Luspatercept

Once 1.75 mg/kg on Day 1 of each 21-day cycle for 24 weeks (9 cycles)

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • GWT-TUD GmbH

    lead OTHER

Principal Investigators

  • Katharina Götze, Prof. · Klinikum rechts der Isar der Technischen Universität München

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2026-10-31
Completion
2027-02-28

Countries

  • Austria
  • Germany
  • Spain
  • Switzerland

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 NCT05181592 on ClinicalTrials.gov