Luspatercept for Clonal Cytopenias of Uncertain Significance

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06788691
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Luspatercept — DRUG
    Administered at 1 mg/kg once every 3 weeks

Study Details

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.

Key Dates

Start date
Mar 25, 2025
Status verified
Mar 2026
Primary completion
Feb 28, 2027
Completion
Feb 29, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Luspatercept
    Luspatercept administered at 1 mg/kg IV once every 3 weeks

Primary Outcome Measure

Number of patients achieving cytopenia responses as defined by HI-E, HI-P, HI-N, mHI-E responses [ Time Frame: 24 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medical CollegeNew YorkNew York10021
Pinkal Desai, MD
[email protected]
646-962-2700
Ameenah Sukkur, BA
[email protected]
646-962-4580

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