A Study to Assess Luspatercept in Lower-risk Myelodysplastic Syndrome Participants (MAXILUS)
Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Luspatercept, Transfusion dependent, ACE-536, Anemia, Blood Transfusion, Red Blood Cell Transfusion, Myelodysplastic Syndrome
Eligibility Criteria
Inclusion Criteria: Participant had documented diagnosis of MDS according to World Health Organization (WHO) classification that met Revised International Prognostic Scoring System (IPSS-R) classification of very low-, low-, or intermediate-risk disease. Participant has an Eastern Cooperative Oncology Group (ECOG) score of 0, 1, or 2. Participant must have red blood cell transfusions according to study criteria. Exclusion Criteria: Participant has known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding. Participant has had a prior allogeneic or autologous stem cell transplant. Participant has known history or diagnosis of AML. Participant has uncontrolled hypertension. Other protocol-defined inclusion/exclusion criteria apply
Sites / Locations
- Cancer and Blood Specialty ClinicRecruiting
- Scripps Prebys Cancer Center
- Smilow Cancer Hospital at Yale New Haven
- Sylvester Comprehensive Cancer Center-Miami
- University of Kansas Medical Center
- Mercy Health - Paducah Medical Oncology and Hematology
- UMass Memorial Medical Center
- Henry Ford Hospital
- Dartmouth Hitchcock Medical Center
- Icahn School of Medicine at Mount Sinai
- James Cancer Hospital and Solove Research Institute - 460 W 10th Ave
- Oncology Associates of Oregon, P.C.
- West Penn Hospital
- Texas Oncology - Amarillo
- North Houston Cancer Clinics - HuntsvilleRecruiting
- Wheeling Hospital Schiffler Cancer Center
- Froedtert and The Medical College of Wisconsin
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- Auxilio Mutuo Cancer Center
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Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Cohort 1: erythropoiesis-stimulating agents (ESA) naïve
Cohort 2: ESA relapsed or refractory