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Brief Title: A Study of Evorpacept (ALX148) With Azacitidine for Higher Risk Myelodysplastic Syndrome (ASPEN-02)
Official Title: A Phase 1/2 Study of Evorpacept (ALX148) in Combination With Azacitidine in Patients With Higher Risk Myelodysplastic Syndrome (MDS) (ASPEN-02)
Study ID: NCT04417517
Brief Summary: This Phase 1/2 clinical study will evaluate evorpacept (ALX148) in combination with azacitidine for the treatment of patients with higher risk myelodysplastic syndrome (MDS).
Detailed Description: The Phase 1 will consist of a dose escalation of evorpacept (ALX148) in combination with azacitidine to evaluate safety and tolerability, and to identify the recommended Phase 2 dose of ALX148 in combination with azacitidine. The Phase 2 will evaluate the efficacy of evorpacept (ALX148) in combination with azacitidine compared to azacitidine alone for patients with previously untreated higher risk MDS.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
IU Simon Cancer Center, Indianapolis, Indiana, United States
START Midwest, Grand Rapids, Michigan, United States
Mayo Clinic, Rochester, Minnesota, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital San Pedro de Alcantara, Cáceres, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain