Treatment Patterns and Outcomes in Patients With Lower-risk Myelodysplastic Syndromes Treated With Luspatercept in China
- Registration Number
- NCT07073690
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- 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.
Exclusion Criteria
- Had a history of acute myeloid leukemia (AML) prior to MDS diagnosis.
- Received stem cell transplant prior to luspatercept treatment initiation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants receiving luspatercept treatment Luspatercept -
- Primary Outcome Measures
Name Time Method Participant red blood cell transfusion independence Up to 12-weeks Participants mean hemoglobin (Hb) increase ≥1.5 g/dL Up to 12-weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Zhijian Xiao
🇨🇳Tianjin, China
Zhijian Xiao🇨🇳Tianjin, China