Completed
Phase 2
Age: 60Years +
All Genders
ID00528333
A Phase IIB, Randomized, Double-Blinded, Placebo-Controlled Study of Low Dose Cytarabine and Lintuzumab Compared to Low Dose Cytarabine and Placebo in Patients 60 Years of Age and Older With Previously Untreated AML
Led by Seagen Inc. · Updated on 2015-01-07
211
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Brief Title
A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
Who Can Participate
Age: 60Years +
All Genders
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).
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