A Study of Lintuzumab (SGN-33) in Combination With Low Dose Cytarabine in Patients 60+ Years With AML
This study has been completed.
Sponsor:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00528333
First received: September 10, 2007
Last updated: October 7, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia |
Drug: Lintuzumab (SGN-33) Drug: Low dose cytarabine Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Seattle Genetics, Inc.:
Primary Outcome Measures:
- Overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Complete blood counts (CBC), Transfusion Requirements, Infections or Fevers of Unknown Origin Requiring Hospitalization or IV Antibiotics [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 211 |
| Study Start Date: | September 2007 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Lintuzumab plus low dose cytarabine
|
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.
Other Name: SGN-33
Drug: 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.
Other Name: Ara-C, Cytosar
|
|
Active Comparator: 2
Placebo plus low dose cytarabine
|
Drug: 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.
Other Name: Ara-C, Cytosar
Drug: 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
|
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00528333
Locations
| United States, Alabama | |
| Southern Cancer Center | |
| Mobile, Alabama, United States, 36608 | |
| United States, California | |
| Tower Cancer Research Foundation | |
| Beverly Hills, California, United States, 90210 | |
| Glendale Memorial Hospital | |
| Glendale, California, United States, 91204 | |
| Kenmar Research Institute | |
| Los Angeles, California, United States, 90057 | |
| University of California Los Angeles | |
| Los Angeles, California, United States, 90095-1678 | |
| Bay Area Cancer Research Group | |
| Pleasant Hill, California, United States, 94523 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Lakeland Regional Cancer Center | |
| Lakeland, Florida, United States, 33805 | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Joliet Oncology-Hematology Associates | |
| Joliet, Illinois, United States, 60435 | |
| United States, Michigan | |
| Michigan State University, Breslin Cancer Center | |
| Lansing, Michigan, United States, 48910 | |
| United States, Montana | |
| Billings Clinic Cancer Research | |
| Billings, Montana, United States, 59101 | |
| United States, New York | |
| Northshore University Hospital, Monter Cancer Center | |
| Lake Success, New York, United States, 11042 | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Western Pennsylvania Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, South Carolina | |
| Cancer Centers of the Carolinas | |
| Greenville, South Carolina, United States, 29601 | |
| United States, Texas | |
| University of Texas, MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Gunderson Clinic | |
| La Crosse, Wisconsin, United States, 54601 | |
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
| Study Director: | Eric Sievers, MD | Seattle Genetics, Inc. |
More Information
No publications provided by Seattle Genetics, Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00528333 History of Changes |
| Other Study ID Numbers: | SG033-0003 |
| Study First Received: | September 10, 2007 |
| Last Updated: | October 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Genetics, Inc.:
|
Lintuzumab Antigens, CD33 Antibodies, Monoclonal |
Leukemia, Myeloid, Acute Hematologic Diseases Leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Cytarabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013