Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy, Drug Levels and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in Chinese and Japanese Participants With Ring Sideroblasts Who Require Red Blood Cell Transfusions
Lead Sponsor:
Celgene
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of luspatercept (ACE-536) for the treatment of anemia due to Revised International Prognostic Scoring System (IPSS-R) very low, low, or...
Eligibility Criteria
Inclusion
- Refractory or intolerant to, or ineligible for, prior Erythropoiesis stimulating agent (ESA) treatment as defined by any one of the following: Refractory to prior ESA treatment, Intolerant to prior ESA treatment, or ESA ineligible.
- previously treated with an ESA or granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, both agents must have been discontinued ≥ 4 weeks prior to date of luspatercept treatment
- Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2
Exclusion
- Prior therapy with disease modifying agents for underlying MDS disease
- Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
- Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) or alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN)
- Other protocol-defined inclusion/exclusion criteria apply
Key Trial Info
Start Date :
November 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04477850
Start Date
November 30 2020
End Date
February 23 2026
Last Update
October 12 2023
Active Locations (24)
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1
Local Institution - 100
Beijing, China, 100730
2
Local Institution - 107
Chengdu, Sichuan, China, 610041
3
Local Institution - 105
Guangzhou, China, 510060
4
Local Institution - 103
Guangzhou, China, 510080