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
1 other identifier
interventional
211
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2007
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 10, 2007
CompletedFirst Posted
Study publicly available on registry
September 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJanuary 7, 2015
December 1, 2014
2.9 years
September 10, 2007
December 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
12 months
Secondary Outcomes (1)
Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics
13 months
Study Arms (2)
1
EXPERIMENTALLintuzumab plus low dose cytarabine
2
ACTIVE COMPARATORPlacebo plus low dose cytarabine
Interventions
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.
20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seagen Inc.lead
Study Sites (20)
Southern Cancer Center
Mobile, Alabama, 36608, United States
Tower Cancer Research Foundation
Beverly Hills, California, 90210, United States
Glendale Memorial Hospital
Glendale, California, 91204, United States
Kenmar Research Institute
Los Angeles, California, 90057, United States
University of California Los Angeles
Los Angeles, California, 90095-1678, United States
Bay Area Cancer Research Group
Pleasant Hill, California, 94523, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Joliet Oncology-Hematology Associates
Joliet, Illinois, 60435, United States
Michigan State University, Breslin Cancer Center
Lansing, Michigan, 48910, United States
Billings Clinic Cancer Research
Billings, Montana, 59101, United States
Northshore University Hospital, Monter Cancer Center
Lake Success, New York, 11042, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Western Pennsylvania Cancer Institute
Pittsburgh, Pennsylvania, 15224, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29601, United States
University of Texas, MD Anderson Cancer Center
Houston, Texas, 77030, United States
Gunderson Clinic
La Crosse, Wisconsin, 54601, United States
Related Publications (1)
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.
PMID: 22801961RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eric Sievers, MD
Seagen Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2007
First Posted
September 12, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
January 7, 2015
Record last verified: 2014-12