Actively Recruiting
Luspatercept + Darbepoetin in MDS
Led by Yale University · Updated on 2026-03-23
60
Participants Needed
3
Research Sites
241 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single arm open-label Phase II trial of luspatercept and darbepoetin alfa in non-mutated SF3B1 , lower-risk, RBC transfusion dependent MDS participants with an endogenous erythropoietin (EPO) level \< 500 IU/L.
CONDITIONS
Official Title
Luspatercept + Darbepoetin in MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign a written informed consent document
- 18 years of age or older at time of consent
- Lower-risk myelodysplastic syndrome (MDS) defined as very low, low, or intermediate risk by IPSS-R criteria
- Bone marrow biopsy within 90 days before screening showing less than 5% blasts
- No SF3B1 mutation and no del5q
- Endogenous serum erythropoietin (EPO) level less than 500 IU/L
- Red blood cell transfusion dependent, defined as 2 or more packed red blood cell units every 8 weeks for at least 8 weeks before screening
- ECOG performance status of 0 to 3
- Adequate organ function including liver enzymes ≤3x ULN (or ≤5x ULN if related to myeloid malignancy), direct bilirubin <1.5x ULN, and creatinine clearance >30 mL/min
- Not pregnant or breastfeeding and agreeing to required contraceptive measures during treatment and for 3 months after last dose
You will not qualify if you...
- Prior treatment with erythropoiesis-stimulating agents, luspatercept, hypomethylating agents, or immunomodulating drugs, except limited doses under specified conditions
- History of seizures
- History of stroke, thrombosis, myocardial infarction, uncontrolled angina, severe heart failure, or uncontrolled arrhythmia within 6 months prior to screening
- Severe complications of myeloid malignancy such as uncontrolled bleeding or pneumonia with hypoxia
- Uncontrolled hypertension despite treatment
- Active HIV, hepatitis B, or hepatitis C infection (controlled HIV allowed)
- Active uncontrolled systemic infections
- Pregnant or lactating participants
- Prior history of malignancies other than MDS unless disease-free for 5 or more years, excluding certain skin and cervical cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
3
Harold C. Simmons Comprehensive Cancer Center of UT Southwestern
Dallas, Texas, United States, 75235
Not Yet Recruiting
Research Team
S
Stephanie Ladd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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