Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS | Aplastic Anemia and MDS International Foundation Identifier:



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Start: February 2016
End: June 2019

Official Title

Study of Vadastuximab Talirine (SGN-CD33A; 33A) in Combination With Azacitidine in Patients With Previously Untreated Higher Risk MDS


This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).  Primary objectives include determining the recommended dose of vadastuximab talirine (SGN-CD33A) in combination with azacitidine (in the open-label Phase 1 portion), and to compare the overall response rate between treatment arms (in the randomized, double-blinded, placebo-controlled Phase 2 portion).


If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Associated Drug(s): 
Phase 1
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
Inclusion Criteria: 
  • Subjects with cytologically/histologically confirmed MDS according to the World Health Organization (WHO) 2008 classification.
  • Previously untreated for Myelodysplastic Syndrome (MDS)
  • Age ≥18 years of age.
  • Eligible for therapy with azacitidine.
  • Life expectancy of at least 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Adequate baseline laboratory parameters.
Exclusion Criteria: 
  • Received prior treatment for MDS with lenalidomide or hypomethylating agents (HMAs).
  • History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
  • Second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment, eg, prostate or breast cancer).

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