Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2017-10-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL))

• Intermediate or adverse cytogenetic risk

• Eligible for therapy with either decitabine or azacitidine

• Acceptable hematologic and organ function

Exclusion Criteria:

• AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17)

• Patients who are candidates for allogeneic stem cell transplant at the time of enrollment

• Patients with a history of one of the following myeloproliferative neoplasms:

essential thrombocythemia, polycythemia vera, and primary myelofibrosis

• Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)