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 range18 Years
SexALL
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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)
✓. Cohort 2: SF3B1 mutation with prior treatment with hypomethylating agent and or lenalidomide
Exclusion criteria
✕. Prior allogeneic or autologous stem cell transplant
✕. MDS associated with del 5q cytogenetic abnormality if no prior lenalidomide treatment
✕. Uncontrolled hypertension, defined as repeated elevations of diastolic blood pressure (DBP) ≥ 100 mmHg despite adequate treatment
✕. ANC \< 500/μL (0.5 x 109/L)
✕. Platelet count ˂50,000/μL (50 x 109/L)
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