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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00528333

Enrollment

211

Registered

2007-09-12

Start date

2007-09-30

Completion date

2010-08-31

Last updated

2015-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Lintuzumab, Antigens, CD33, Antibodies, Monoclonal, Leukemia, Myeloid, Acute, Hematologic Diseases, Leukemia

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.

Interventions

DRUGLintuzumab (SGN-33)

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.

DRUGLow dose cytarabine

20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
Overall survival	12 months

Secondary

Measure	Time frame
Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics	13 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026