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)

Protocol: 
AAAQ6461
Phase: 
I/II

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)

Phase 1: To determine the recommended vadastuximab talirine (SGN-CD33A) dose in combination with azacitidine. Phase 2: To compare the overall response rate (ORR = complete response + partial response [CR+PR]) between treatment arms.

Are you Eligible? (Inclusion Criteria)

1. Subjects with cytologically/histologically confirmed MDS according to the WHO
2008 classification, that is determined to be Intermediate-2 (1.5-2-points) or High risk (>=2.5 points)
according to the IPSS risk category, with >=5% and <20% bone marrow blasts.
2. Previously untreated for MDS with the exception of transfusions, hematopoietic
growth factors, or IST.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States