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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Treatments: Antibodies, Monoclonal; Cytarabine; Lintuzumab

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).