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Active Not Recruiting
NCT06113302
A Pilot, Open-Label Study of Luspatercept for Patients With Lower Risk Myelodysplastic Syndromes (MDS)
Conditions: Myelodysplastic Syndromes
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 10
Sponsor: M.D. Anderson Cancer Center
Location: M D Anderson Cancer Center Houston Texas
Summary
To learn if luspatercept is more effective in helping to reduce the number of blood transfusions needed by patients with LR-MDS.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years; as MDS there is no significant experience with luspatercept in pediatric patients
2. Cohorts #1 and #2: Diagnosis of MDS according to WHO 2023 criteria (5) and with low or int-1 risk by IPSS or a score of ≤ 3.5 by IPSS-R.(3, 22)
3. Cohort #2: Patient defined as transfusion dependent by documentation of receiving at least 2 units of packed red blood cells (PRBCs) for a hemoglobin of less than 8.0 g/dL during an 8-week period prior to study enrollment.
4. Cohort #1: Patients with symptomatic anemia that are transfusion independent defined as not requiring a transfusion for a hemoglobin of less than 8.0 g/dL during an 8-week period prior to study enrollment.
5. MDS patients with either a platelet count of ≤100 K/uL and/or ANC of ≤1.8 K/uL
6. Patient must have signed an informed consent and is willing to participate in the study.
7. Adequate hepatic function with total bilirubin ≤3 x ULN, AST or ALT ≤3xULN.
8. Serum creatinine clearance ≥40mL/min and no end/stage renal disease (using Cockcroft-Gault).
9. ECOG performance status \
Source: ClinicalTrials.gov (NCT06113302). StuddyBuddy aggregates publicly available trial information.