Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN

This study is looking at luspatercept, a medication given as an injection under the skin every three weeks, for people with anemia (low red blood cell count) caused by Myelodysplastic Syndromes (MDS) or certain Myeloproliferative Neoplasms (MDS/MPN). The main goal is to see if luspatercept can reduce your need for regular blood transfusions. Researchers will also be watching for any good or bad effects of luspatercept on your anemia and overall health. You may be able to join if you are 18 or older and have a confirmed diagnosis of MDS or non-proliferative MDS/MPN. The study is currently recruiting a small number of participants, with a planned enrollment of 6 people.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It is planned to enroll 6 participants.
What's involved: You will receive luspatercept as a subcutaneous injection every 3 weeks. You will need to adhere to the study visit schedule and other protocol requirements.
Compensation: Not stated in the trial record.
Follow-up: Your need for red blood cell transfusions will be measured from the start of treatment for up to 18 months.

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Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms

Active, Not Recruiting

PHASE2Ages 18+InterventionalTreatment

H. Lee Moffitt Cancer Center and Research Institute

~6 participants

Updated 2026-05-05 on ClinicalTrials.gov

What's tested:Luspatercept

At a glance

Recruiting sites

0 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

RBC Transfusion Independence

Measured over From start of treatment to up to 18 months

Conditions

Myelodysplastic Syndromes

Myeloproliferative Neoplasm

Anemia

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Rami Komrokji, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

rHu EPO ≥ 40,000 IU/wk for at least 8 doses or equivalent Or darbepoetin alpha ≥ 500 μg Q3W for at least 4 doses or equivalent 2. Intolerant to prior ESA treatment - discontinuation of prior ESA-containing regimen, at any time after introduction due to intolerance or AE 3. ESA ineligible - Low chance of response to ESA based on endogenous serum EPO \> 200 U/L for subjects not previously treated with ESAs 7. Discontinuation of ESAs, G-CSF, GM-CSF ≥ 4 weeks prior to start of study treatment 8. Require RBC transfusions

Have two negative pregnancy tests 48 hours apart as verified by the investigator prior to starting study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices true abstinence\* from heterosexual contact.

Either commit to true abstinence\*from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use, and be able to comply with highly effective, contraception without interruption, 35 days prior to starting 10. investigational product (IP), during the study therapy (including dose interruptions), and for 84 days after discontinuation of study therapy 11. Applies to on treatment subjects only - Male subjects must:

What this trial measures

RBC Transfusion IndependenceFrom start of treatment to up to 18 months
RBC transfusion independence (RBC-TI) as defined by IWG 2006 MDS response criteria

Trialytics