Spots Global Cancer Trial Database for A Study of Aezea® (Cenersen) in Transfusion Dependent Anemia Associated With Myelodysplastic Syndrome (MDS)
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Trial Identification
Brief Title: A Study of Aezea® (Cenersen) in Transfusion Dependent Anemia Associated With Myelodysplastic Syndrome (MDS)
Official Title: A Study of Aezea® (Cenersen) in Transfusion Dependent Anemia Associated With Myelodysplastic Syndrome
Study ID: NCT02243124
Conditions
Study Description
Brief Summary: The purpose of the study is to test the safety of six cycles of cenersen treatment and to begin to test the hypothesis that intermittent administration of cenersen may lead to a reduced dependence on transfusion.
Detailed Description: The study is a nonrandomized open-label treatment with varying doses of cenersen by intravenous administration to: Primary \*To assess the safety profile and dose limiting toxicities (DLT) of cenersen for each of three increasing dose levels as stipulated by the protocol in patients with lower risk MDS defined as low or intermediate-1 risk by IPSS. Secondary * To determine the lowest pharmacologically active exposure from among three increasing dose levels as stipulated by the protocol that exhibits the desired activity on erythropoiesis after evaluation of all dose levels, and * To determine if intermittent treatment with cenersen will reduce transfusion requirements for patients with lower risk MDS.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Contact Details
Name: Rami Komrokji, MD
Affiliation: H. Lee Moffitt Cancer Center and Research Institute
Role: PRINCIPAL_INVESTIGATOR
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