Status:
UNKNOWN
Roxadustat Combined With Luspatercept Versus Luspatercept Monotherapy in the Treatment of Refractory MDS-RS
Lead Sponsor:
Peking Union Medical College Hospital
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
In a randomized controlled phase II/III clinical trial, 58% of patients with lower-risk MDS had at least a 50% reduction in red blood cell (RBC) transfusion units every 8 weeks after roxadustat treatm...
Detailed Description
Myelodysplastic neoplasms (MDS) are heterogeneous clonal disorders of stem cells that result in peripheral blood cytopenia and ineffective hematopoiesis, with the potential risk of the development of ...
Eligibility Criteria
Inclusion
- Age \>18 years old.
- Patients with a definite diagnosis of MDS-RS and stratified as lower-risk according to IPSS-R.
- After at least 6 weeks of rhEPO treatment, with hemoglobin\<100g/L
- Adequate hepatic functions with alanine transaminase (ALT)/aspartate. transaminase (AST) levels within 2 times of the normal upper limit and total bilirubin levels within 2 times of the normal upper limit.
- ECOG≤2 with an expected life span of more than 6 months
- Documented patient consent.
Exclusion
- Age \<18 years old.
- Complicated with active or uncontrolled infections.
- Complicated with other malignancies.
- Creatinine/transaminase ≥ 2 normal upper limit.
- Complicated with myelofibrosis.
- Pregnant or lactating women, or men with recent fertility needs
- Allergic to luspatercept or excipients
- Patients with history of polysorbate 80 allergy
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06006949
Start Date
August 1 2023
End Date
August 1 2025
Last Update
August 23 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking union medical college hospital
Beijing, China