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

• Status: Terminated
• Trial end date: 2017-11-06
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1/2 study to evaluate the combination of vadastuximab talirine (SGN-CD33A; 33A) and azacitidine in subjects with previously untreated International Prognostic Scoring System (IPSS) Intermediate-2 or high risk myelodysplastic syndrome (MDS).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Azacitidine

Criteria

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).

• Candidates for allogeneic stem cell transplant at the time of screening.