Actively Recruiting
Luspatercept for Clonal Cytopenias of Uncertain Significance
Led by Weill Medical College of Cornell University · Updated on 2026-03-24
50
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
W
Weill Medical College of Cornell University
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to test how well the drug luspatercept works in improving low blood cell counts in people with clonal cytopenias of uncertain significance (CCUS). The main questions the study seeks to answer include: * How many patients experience improvements in their low blood counts (red cells, platelets, or white cells) within 24 weeks, based on specific criteria for blood conditions like myelodysplastic syndromes (MDS)? * How long these improvements last before the condition worsens or changes. * The percentage of participants showing improvements at 12, 24, and 48 weeks. * How long it takes for the condition to progress to more severe diseases like myeloid disorders. * How long red blood cell responses last and how quickly these responses are seen. * The average change in hemoglobin levels over 24 weeks. * How many patients need blood transfusions during the study and how soon transfusions are required. * Changes in participants' well-being and energy levels based on a standardized questionnaire. * Monitoring for any side effects, including progression to MDS or leukemia, heart-related issues, or sudden increases in hemoglobin. Participants will: * Receive luspatercept as an injection every three weeks. * Visit the clinic every three weeks for treatment and monitoring.
CONDITIONS
Official Title
Luspatercept for Clonal Cytopenias of Uncertain Significance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older
- Diagnosis of clonal cytopenia of undetermined significance (CCUS) confirmed by specific blood test criteria
- Presence of clinically significant low blood counts confirmed in two separate lab tests including anemia, thrombocytopenia, or neutropenia under defined thresholds
- ECOG performance status of 0, 1, or 2
- Adequate organ function including bilirubin, kidney, and liver function within specified limits
- Females of childbearing potential must have negative pregnancy tests before and during the study and agree to use effective contraception
- Male participants must agree to use condoms or practice abstinence during the study and for 12 weeks after treatment
You will not qualify if you...
- Active cancers requiring chemotherapy other than hormonal therapy or targeted radiation
- Previous diagnosis of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), or other myeloid malignancies
- Uncontrolled infections or uncontrolled high blood pressure deemed unsafe by the investigator
- Use of erythropoiesis-stimulating agents or growth factors within four weeks prior to study start
- Known risk factors for blood clots such as recent pulmonary embolism or deep vein thrombosis unless well controlled with medication
- Pregnant or nursing women or women not using required contraception methods
- Women who are not postmenopausal or have not had surgical sterilization as defined in the criteria
AI-Screening
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Trial Site Locations
Total: 1 location
1
Weill Cornell Medical College
New York, New York, United States, 10021
Actively Recruiting
Research Team
P
Pinkal Desai, MD
CONTACT
A
Ameenah Sukkur, BA
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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