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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Lintuzumab (SGN-33)
* Drug: Low dose cytarabine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lintuzumab plus low dose cytarabine | Drug: Lintuzumab (SGN-33)<br>* 600 mg IV on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles.<br>* Other names: SGN-33;Drug: Low dose cytarabine<br>* 20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.<br>* Other names: Ara-C, Cytosar;|
| Active Comparator: 2<br>Placebo plus low dose cytarabine | Drug: Low dose cytarabine<br>* 20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.<br>* Other names: Ara-C, Cytosar;Drug: Placebo<br>* IV administration on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of each subsequent 28-day cycle up to a maximum of 12 cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics |  | 13 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Hematologic Diseases, Leukemia