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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00528333
• Other study ID #: SG033-0003
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2007
• Last updated: December 17, 2014
• Start date: September 2007
• Est. completion date: August 2010

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Lintuzumab (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.
• Low dose cytarabine
20 mg SC twice a day on days 1-10 of each 28 day cycle up to a maximum of 12 cycles.
• Placebo
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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		12 months	No
Secondary	Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics		13 months	Yes