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

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Low dose cytarabine
Drug: Lintuzumab (SGN-33)
Drug: Placebo

Registration Number: NCT00528333

Lead Sponsor: Seagen Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 211

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Low dose cytarabine	Placebo plus low dose cytarabine
2	Placebo	Placebo plus low dose cytarabine
1	Low dose cytarabine	Lintuzumab plus low dose cytarabine
1	Lintuzumab (SGN-33)	Lintuzumab plus low dose cytarabine

Primary Outcome Measures

Name	Time	Method
Overall survival	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (20): Lakeland Regional Cancer Center
🇺🇸
Lakeland, Florida, United States
Cancer Centers of the Carolinas
🇺🇸
Greenville, South Carolina, United States
Gunderson Clinic
🇺🇸
La Crosse, Wisconsin, United States
Southern Cancer Center
🇺🇸
Mobile, Alabama, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
Kenmar Research Institute
🇺🇸
Los Angeles, California, United States
Michigan State University, Breslin Cancer Center
🇺🇸
Lansing, Michigan, United States
University of Texas, MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
Western Pennsylvania Cancer Institute
🇺🇸
Pittsburgh, Pennsylvania, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Billings Clinic Cancer Research
🇺🇸
Billings, Montana, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States
Northshore University Hospital, Monter Cancer Center
🇺🇸
Lake Success, New York, United States
Joliet Oncology-Hematology Associates
🇺🇸
Joliet, Illinois, United States
Tower Cancer Research Foundation
🇺🇸
Beverly Hills, California, United States
Glendale Memorial Hospital
🇺🇸
Glendale, California, United States
University of California Los Angeles
🇺🇸
Los Angeles, California, United States
Bay Area Cancer Research Group
🇺🇸
Pleasant Hill, California, United States
University of Colorado Cancer Center
🇺🇸
Aurora, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute
🇺🇸
Tampa, Florida, United States