NCT04477850CompletedPhase 2
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
A Phase 2, Multicenter, Single-Arm Bridging Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Luspatercept (ACE-536) for the Treatment of Anemia Due to IPSS-R Very Low, Low or Intermediate Risk Myelodysplastic Syndromes(MDS) in Chinese and Japanese Subjects With Ring Sideroblasts Who Require Red Blood Cell Transfusions
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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 intermediate risk myelodysplastic syndromes (MDS) in Chinese and Japanese participants with ring sideroblasts who require Red Blood Cells (RBC) transfusions.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 23 Jun 2020
- Start date
- 30 Nov 2020
- Primary completion date
- 29 Sept 2023
- Lead sponsor
- Celgene
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT04477850
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 30
- From 30 Nov 2020 to the primary completion date, 29 Sept 2023
- 25 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior therapy with disease modifying agents for underlying MDS disease
Other illness
- Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
Lab values
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Local Institution - 100 Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Local Institution - 107 Coordinator of this site? Confirm its status | Chengdu, Sichuan | China | Unknown status |
| Local Institution - 103 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 109 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 105 Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Local Institution - 102 Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Local Institution - 112 Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Local Institution - 108 Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Local Institution - 114 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 101 Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Local Institution - 104 Coordinator of this site? Confirm its status | Suzhu | China | Unknown status |
| Local Institution - 106 Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Local Institution - 111 Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Local Institution - 110 Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Local Institution - UNK11 Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Local Institution - 206 Coordinator of this site? Confirm its status | Kamogawa | Japan | Unknown status |
| Local Institution - 209 Coordinator of this site? Confirm its status | Matsuyama | Japan | Unknown status |
| Local Institution - 201 Coordinator of this site? Confirm its status | Mibu-Machi | Japan | Unknown status |
| Local Institution - 203 Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Local Institution - 208 Coordinator of this site? Confirm its status | Ōgaki | Japan | Unknown status |
| Local Institution - 205 Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Local Institution - 204 Coordinator of this site? Confirm its status | Sagamihara | Japan | Unknown status |
| Local Institution - 210 Coordinator of this site? Confirm its status | Sayama | Japan | Unknown status |
| Local Institution - 207 Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Local Institution - 202 Coordinator of this site? Confirm its status | Shinagawa-ku, Tokyo | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.