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

ClinicalTrials.gov Identifier:

NCT02706899

Company

Seattle Genetics

Contact Info

Seattle Genetics Trial Information Support

clinicaltrials@seagen.com

(866) 333-7436

Dates

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

Purpose

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).

Instructions

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.

Status: 
Suspended
Associated Drug(s): 
Phase: 
Phase 1
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
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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