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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/┬ÁL

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 CenterNew York, New York  10021
Cleveland Clinic FoundationCleveland, Ohio  44195
University of Colorado Cancer CenterDenver, Colorado  80262
Rush University Medical CenterChicago, Illinois  60612-3824
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Western Pennsylvania Cancer InstitutePittsburgh, Pennsylvania  15224
University of California Los AngelesLos Angeles, California  90095-6951
Tower Cancer Research FoundationBeverly Hills, California  90211
Kenmar Research InstituteLos Angeles, California  90057
Lakeland Regional Cancer CenterLakeland, Florida  33805
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
Glendale Memorial HospitalGlendale, California  91204
Bay Area Cancer Research GroupConcord, California  94520
University of Texas, MD Anderson Cancer CenterHouston, Texas  77030
Gunderson ClinicLaCrosse, Wisconsin  54601
Southern Cancer CenterMobile, Alabama  36608
Joliet Oncology-Hematology AssociatesJoliet, Illinois  60435
Michigan State University, Breslin Cancer CenterLansing, Michigan  48910
Billings Clinic Cancer ResearchBillings, Montana  59101
Northshore University Hospital, Monter Cancer CenterLake Success, New York  11042