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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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06113302). StuddyBuddy aggregates publicly available trial information.