A Phase 1/2 Study of Vadastuximab Talirine (SGN-CD33A) In Combination with Azacitidine in Patients with Previously Untreated International Prognostic Scoring System (IPSS) Intermediate -2 or High-Risk Myelodysplastic Syndrome (MDS)
A study for patients with Myelodysplastic Syndrome (MDS) using study drug Vadastuximab Talirine
Sponsor: Seattle Genetics, Inc
Enrolling: Male and Female Patients
IRB Number: AAAQ6461
U.S. Govt. ID: NCT02706899
Contact: Joseph Jurcic: 646-317-5191 / jgj2110@cumc.columbia.edu
Additional Study Information: This study is for patients have been diagnosed with Intermediate or High-risk myelodysplastic syndrome (MDS). MDS is a condition where there is a low count of white blood cells, red blood cells and platelets because of a malfunction of bone marrow that is responsible for producing healthy mature blood cells. evaluate the combination of the investigational medicine, vadastuximab talirine (SGN-CD33A) and azacitidine in subjects with previously untreated Intermediate or High-risk MDS. In the Phase 1 portion of the trial, multiple dose levels of vadastuximab talirine will be evaluated in combination with azacitidine. One dose will be selected for the randomized, double-blind , placebo-controlled Phase 2 portion of the study. Randomized means selected by chance, like flipping a coin and double-blind means that neither you nor the investigators will know which dose is assigned. The Phase 2 portion of the study is designed to compare the overall response rate between 2 study arms: azacitidine plus vadastuximab talirine versus azacitidine plus placebo.
This study is closed
Investigator
Joseph Jurcic, MD
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For more information, please contact:
Joseph Jurcic
jgj2110@cumc.columbia.edu
646-317-5191