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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT02785900

Run by

Seagen Inc.

People needed

240

Starts

2016-05-01

Expected to finish

2017-10-03

Last updated by the study team

2018-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• Pacific Hematology Oncology Associates — San Francisco, California, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• Florida Cancer Specialists - South Region — Fort Myers, Florida, United States
• Shands Cancer Center / University of Florida — Gainesville, Florida, United States
• Memorial Cancer Institute — Miami, Florida, United States
• Florida Center for Cellular Therapy / Blood and Marrow Transplant Center — Orlando, Florida, United States
• Florida Cancer Specialists - North Region — St. Petersburg, Florida, United States
• Northside Hospital — Atlanta, Georgia, United States
• OnCare Hawaii — Honolulu, Hawaii, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Cancer Center — Westwood, Kansas, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• LSU Health Sciences Center / Feist Weiller Cancer Center — Shreveport, Louisiana, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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