Clinical trial NCT00528333: A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: Lintuzumab
Antigens, CD33
Antibodies, Monoclonal
Leukemia, Myeloid, Acute
Hematologic Diseases
Leukemia
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2007-09-12
Enrollment: 211
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Overall survival
timeFrame: 12 months
Secondary outcomes:
measure: Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics
timeFrame: 13 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation
state: California
city: Glendale
country: United States
facility: Glendale Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Kenmar Research Institute
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Pleasant Hill
country: United States
facility: Bay Area Cancer Research Group
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology-Hematology Associates
state: Illinois
city: Lansing
country: United States
facility: Michigan State University, Breslin Cancer Center
state: Michigan
city: Billings
country: United States
facility: Billings Clinic Cancer Research
state: Montana
city: Lake Success
country: United States
facility: Northshore University Hospital, Monter Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: Western Pennsylvania Cancer Institute
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Houston
country: United States
facility: University of Texas, MD Anderson Cancer Center
state: Texas
city: La Crosse
country: United States
facility: Gunderson Clinic
state: Wisconsin
Study officials:
affiliation: Seagen Inc.
name: Eric Sievers, MD
role: STUDY_DIRECTOR
References:
citation: Sekeres MA, Lancet JE, Wood BL, Grove LE, Sandalic L, Sievers EL, Jurcic JG. Randomized phase IIb study of low-dose cytarabine and lintuzumab versus low-dose cytarabine and placebo in older adults with untreated acute myeloid leukemia. Haematologica. 2013 Jan;98(1):119-28. doi: 10.3324/haematol.2012.066613. Epub 2012 Jul 16.