Actively Recruiting
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
Led by M.D. Anderson Cancer Center · Updated on 2026-05-04
40
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if luspatercept is more effective in helping to reduce the number of blood transfusions needed by patients with LR-MDS.
CONDITIONS
Official Title
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of myelodysplastic syndromes (MDS) with low or intermediate-1 risk by IPSS or IPSS-R score 4 or less
- Transfusion dependent patients (at least 2 units of packed red blood cells in past 8 weeks) or transfusion independent with symptomatic anemia
- Platelet count 100,000 per microliter or less and/or absolute neutrophil count 1,800 per microliter or less
- Signed informed consent and willingness to participate
- Adequate liver function (bilirubin 4 times upper limit of normal, AST or ALT 4 times upper limit of normal)
- Serum creatinine clearance 40 mL/min or higher without end stage renal disease
- ECOG performance status of 0 to 2
You will not qualify if you...
- Active infection not responding to antibiotics
- Previous treatment with luspatercept or sotarcetept
- Pregnant or lactating women
- Patients of reproductive potential unwilling to follow contraception requirements
- Female patients of reproductive potential without a negative pregnancy test at screening
- History of active malignancy in past 2 years except certain treated skin or cervical cancers
- Use of other investigational agents, chemotherapy, radiotherapy, or immunotherapy within 14 days before study treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Guillermo Garcia-Manero, M D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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