Treatment Patterns and Outcomes in Patients With Lower-risk Myelodysplastic Syndromes Treated With Luspatercept in China

NCT07073690 | Active Not Recruiting FDA Drug

• 1 other identifier: CA056-1166
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the treatment patterns and clinical outcomes in adults with lower-risk MDS (LR-MDS) who were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China

Conditions

Myelodysplastic Syndromes

Keywords

Lower Risk Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (2)

• Participant red blood cell transfusion independence

  Up to 12-weeks

• Participants mean hemoglobin (Hb) increase ≥1.5 g/dL

  Up to 12-weeks

Secondary Outcomes (3)

• Participant transfusion independence and increase in hemoglobin (Hb)

  Up to 48 weeks

• Duration of luspatercept monotherapy treatment

  Up to 48 weeks

• Health Care Resource Utilization (HCRU)

  Up to 48 weeks

Study Arms (1)

Participants receiving luspatercept treatment

Drug: Luspatercept

Interventions

Luspatercept DRUG

According to the product label

Participants receiving luspatercept treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise of individuals ≥18 years of age diagnosed with Lower-Risk Myelodysplastic Syndromes (LR-MDS) were erythropoiesis-stimulating agents (ESA)-naïve and received luspatercept treatment in China

You may qualify if:

• Participants ≥ 18 years of age.
• Documented diagnosis of no del(5q) MDS that meets lower-risk Myelodysplastic Syndromes (MDS) classification. (Diagnosis criteria and risk classification criteria are based on clinical practice)
• Patients who were erythropoiesis-stimulating agent (ESA)-naïve have received luspatercept monotherapy at least 2 cycles regardless of RS status.
• Historical documentation of anemia before luspatercept treatment.

You may not qualify if:

• Had a history of acute myeloid leukemia (AML) prior to MDS diagnosis.
• Received stem cell transplant prior to luspatercept treatment initiation.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Zhijian Xiao

Tianjin, China

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

luspatercept

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 18, 2025
• Study Start: April 18, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)