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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


Phase 2
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Eric Sievers, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG033-0003

NCT ID:

NCT00528333

Start Date:

September 2007

Completion Date:

August 2010

Related Keywords:

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

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
Cleveland Clinic Foundation Cleveland, Ohio  44195
University of Colorado Cancer Center Denver, Colorado  80262
Rush University Medical Center Chicago, Illinois  60612-3824
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Western Pennsylvania Cancer Institute Pittsburgh, Pennsylvania  15224
University of California Los Angeles Los Angeles, California  90095-6951
Tower Cancer Research Foundation Beverly Hills, California  90211
Kenmar Research Institute Los Angeles, California  90057
Lakeland Regional Cancer Center Lakeland, Florida  33805
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Glendale Memorial Hospital Glendale, California  91204
Bay Area Cancer Research Group Concord, California  94520
University of Texas, MD Anderson Cancer Center Houston, Texas  77030
Gunderson Clinic LaCrosse, Wisconsin  54601
Southern Cancer Center Mobile, Alabama  36608
Joliet Oncology-Hematology Associates Joliet, Illinois  60435
Michigan State University, Breslin Cancer Center Lansing, Michigan  48910
Billings Clinic Cancer Research Billings, Montana  59101
Northshore University Hospital, Monter Cancer Center Lake Success, New York  11042