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The Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes

NCT05925504 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-03-12

No results posted yet for this study

Summary

This is a prospective, single center, single-arm, phase 2 study. The aim of this study is to evaluate the efficacy and safety of Luspatercept for Patients with Lower-risk Myelodysplastic Syndromes (MDS).

Conditions

  • Lower Risk MDS Per IPSS-R

Interventions

DRUG

Luspatercept

The starting dose is 1.75mg/kg once every 3 weeks by subcutaneous injection. For rapid hemoglobin rise after 2 consecutive doses at the 1.75mg/kg starting dose, decrease the dose of Luspatercept or interrupt treatment. Otherwise, continue treatment with the dose of 1.75mg/kg once every 3 weeks.

Sponsors & Collaborators

  • Beijing Health Alliance Charitable Foundation

    collaborator UNKNOWN

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2026-06-30
Completion
2026-09-30

Countries

  • China

Study Locations

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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 NCT05925504 on ClinicalTrials.gov