Actively Recruiting
The Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2024-03-12
36
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
B
Beijing Health Alliance Charitable Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a prospective, single center, single-arm, phase 2 study. The aim of this study is to evaluate the efficacy and safety of Luspatercept for Patients with Lower-risk Myelodysplastic Syndromes (MDS).
CONDITIONS
Official Title
The Tapering Dose of Luspatercept in Patients With Lower-risk Myelodysplastic Syndromes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 63 18 years
- Diagnosis of MDS according to WHO classification with IPSS-R score 63 3.5
- Hemoglobin less than 100 g/L at baseline
- Refractory or intolerant to prior ESA treatment or EPO dose 63 500 U/L
- ECOG performance status 63 2
- Willing and able to comply with study requirements and provide written informed consent
You will not qualify if you...
- Platelet counts less than 50 x 10^9/L
- Prior treatment with luspatercept or sotatercept
- Use of immunomodulatory drugs such as lenalidomide for 4 or more weeks prior to study
- Use of immunosuppressive therapy for 4 or more weeks prior to study
- Use of demethylating agents for 1 or more treatment cycles prior to study
- MDS associated with del 5q cytogenetic abnormality
- Secondary MDS caused by chemical injury or prior chemotherapy/radiation
- Clinically significant anemia due to iron, vitamin B12, folate deficiencies, autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
- Prior allogeneic or autologous stem cell transplant
- Prior malignancies other than MDS unless disease-free for 5 or more years, except certain skin, bladder, prostate, cervical, or indolent tumors
- Uncontrolled systemic fungal, bacterial, or viral infections
- Known HIV or active hepatitis B or C infection
- Clinically significant cardiac disease including uncontrolled angina, myocardial infarction, unstable arrhythmias, congestive heart failure NYHA grade 2-4
- Abnormal liver function with ALT and AST 2.5 times above normal on two tests at least 1 week apart
- Renal impairment with creatinine clearance less than 60 ml/min
- Severe or uncontrolled medical conditions affecting participation including refractory hypertension, metabolic disorders, or gastrointestinal dysfunction
- History of psychiatric diseases, cerebrovascular disease, or cognitive sequelae of head injury
- Major surgery within 8 weeks prior to study without complete recovery
- Received attenuated vaccine within 4 weeks before enrollment
- Participation in another clinical trial within 4 weeks before this trial
- History of severe allergic or anaphylactic reactions to recombinant proteins or luspatercept excipients
- Pregnant or breastfeeding
- Investigator-determined ineligibility for reasons other than above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Regenerative Medicine Center
Tianjin, Tianjin Municipality, China, 300131
Actively Recruiting
Research Team
Z
Zhen Gao
CONTACT
J
Jingyu Zhao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here