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Luspatercept for Clonal Cytopenias of Uncertain Significance

NCT06788691 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-24

No results posted yet for this study

Summary

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

Interventions

DRUG

Luspatercept

Administered at 1 mg/kg once every 3 weeks

Sponsors & Collaborators

Principal Investigators

  • Pinkal Desai, MD · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2027-02-28
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06788691 on ClinicalTrials.gov