Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms (NCT05732961) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Luspatercept for Anemia in Lower Risk MDS or Non-proliferative MDS/MPN Neoplasms
United States6 participantsStarted 2023-02-21
Plain-language summary
The purpose of the study is to see if participants with anemia due to their type of MDS or MDS/MPN will experience a more decreased need for regular blood transfusions if they take luspatercept plus best supportive care, and what effect, good and/or bad, luspatercept has on them and their anemia due to MDS or MDS/MPN. The safety and tolerability of luspatercept will also be evaluated in this study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participant is ≥18 years at the time of signing the informed consent form
. Participant is willing and able to adhere to the study visit schedule and other protocol requirements
. Documented diagnosis of MDS or non-proliferative MDS/MPN (WBC \< 13,000 U/L)
. According to WHO 2016 classification
. Meets IPSS-R classification of very low, low, or intermediate risk disease
. Documented acquired splicing gene mutation
. Cohort 1: detectable splicing mutation other than SF3B1: (SRSF2, U2AF1, ZRSR2)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RBC Transfusion Independence
Timeframe: From start of treatment to up to 18 months
Trial details
NCT IDNCT05732961
SponsorH. Lee Moffitt Cancer Center and Research Institute