A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia

In brief

The purpose of this study is to assess whether there is a survival benefit with lintuzumab given in combination with low dose cytarabine versus low dose cytarabine and placebo in patients with AML.

Key facts

Study ID

NCT00528333

Run by

Seagen Inc.

People needed

211

Starts

2007-09-01

Expected to finish

2010-08-01

Last updated by the study team

2015-01-07

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Untreated AML that occurred de novo, after prior exposure to chemotherapy for a separate malignancy, or evolved from an antecedent hematologic disorder.
• After being informed of the potential benefits and risks of available treatment options, patients must have declined intensive chemotherapy for AML.
• At least 20% blasts in blood or marrow.
• Must have a minimum of 50% leukemic blasts that express CD33.
• ECOG performance status score of 0 to 2.
• WBC less than 30,000/µL

You may not qualify if…

• No known diagnosis of acute promyelocytic leukemia or chronic myeloid leukemia.
• No other active systemic malignancies treated with chemotherapy within the last 12 months.
• Must not have received previous chemotherapy (except hydroxyurea) for AML.
• Must not have significantly abnormal kidney or liver disease.
• Must not have known human immunodeficiency virus (HIV).

Where it is running

• Southern Cancer Center — Mobile, Alabama, United States
• Tower Cancer Research Foundation — Beverly Hills, California, United States
• Glendale Memorial Hospital — Glendale, California, United States
• Kenmar Research Institute — Los Angeles, California, United States
• University of California Los Angeles — Los Angeles, California, United States
• Bay Area Cancer Research Group — Pleasant Hill, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Lakeland Regional Cancer Center — Lakeland, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Joliet Oncology-Hematology Associates — Joliet, Illinois, United States
• Michigan State University, Breslin Cancer Center — Lansing, Michigan, United States
• Billings Clinic Cancer Research — Billings, Montana, United States
• Northshore University Hospital, Monter Cancer Center — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Western Pennsylvania Cancer Institute — Pittsburgh, Pennsylvania, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• University of Texas, MD Anderson Cancer Center — Houston, Texas, United States
• Gunderson Clinic — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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