Status:
COMPLETED
A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
Lead Sponsor:
Seagen Inc.
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
211 Patients enrolled
Trial Details
Trial ID
NCT00528333
Start Date
September 1 2007
End Date
August 1 2010
Last Update
January 7 2015
Active Locations (20)
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1
Southern Cancer Center
Mobile, Alabama, United States, 36608
2
Tower Cancer Research Foundation
Beverly Hills, California, United States, 90210
3
Glendale Memorial Hospital
Glendale, California, United States, 91204
4
Kenmar Research Institute
Los Angeles, California, United States, 90057