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)
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 |
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
Have you been diagnosed with MDS? |
Yes |
No |