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

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Myelodysplastic Syndrome

In brief

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).

Key facts

Study ID

NCT02706899

Run by

Seagen Inc.

People needed

19

Starts

2016-02-01

Expected to finish

2017-11-06

Last updated by the study team

2019-02-12

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• University of Southern California — Los Angeles, California, United States
• Rocky Mountain Cancer Centers, LLP — Aurora, Colorado, United States
• Colorado Blood Cancer Institute — Denver, Colorado, United States
• University of Colorado Hospital — Denver, Colorado, United States
• Cancer Specialisits of North Florida — Fleming Island, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Georgia Regents University Hospital — Augusta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• University of Minnesota Medical Center (UMMC) — Minneapolis, Minnesota, United States
• Bozeman Deaconess Health Group — Bozeman, Montana, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• The University of New Mexico Cancer Research and Treatment Center — Albuquerque, New Mexico, United States
• Weill Cornell — Brooklyn, New York, United States
• Westchester Medical Center — Hawthorne, New York, United States
• Columbia University Medical Center — New York, New York, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• Case Western Reserve University (CWRU) - University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Providence Portland Research Center — Portland, Oregon, United States
• Oregon Health & Science — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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