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| Sponsored by: |
Seattle Genetics, Inc. |
|---|---|
| Information provided by: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00528333 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 210 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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.
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.
|
|
2: Active Comparator
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.
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Terri Lowe | 866-333-7436 | clinicaltrials@seagen.com |
| United States, Alabama | |
| Southern Cancer Center | Recruiting |
| Mobile, Alabama, United States, 36606 | |
| Principal Investigator: Paul Schwarzenberger, MD | |
| United States, California | |
| Tower Cancer Research Foundation | Recruiting |
| Beverly Hills, California, United States, 90210 | |
| Principal Investigator: Peter J. Rosen, M.D. | |
| Glendale Memorial Hospital | Recruiting |
| Glendale, California, United States, 91204 | |
| Principal Investigator: Ghassan Al-Jazayrly, MD | |
| Kenmar Research Institute | Recruiting |
| Los Angeles, California, United States, 90057 | |
| Principal Investigator: Maurice Berkowitz, MD | |
| University of California Los Angeles | Not yet recruiting |
| Los Angeles, California, United States, 90024 | |
| Principal Investigator: Gary Schiller, MD | |
| Bay Area Cancer Research Group | Recruiting |
| Concord, California, United States, 94520 | |
| Principal Investigator: Robert Robles, MD | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: Hussain Saba, MD | |
| Lakeland Regional Cancer Center | Recruiting |
| Lakeland, Florida, United States, 33805 | |
| Principal Investigator: Madhavi Venigalla, MD | |
| The Center for Hematology-Oncology | Withdrawn |
| Boca Raton, Florida, United States, 33486 | |
| United States, Illinois | |
| Joliet Oncology-Hematology Associates | Recruiting |
| Joliet, Illinois, United States, 60435 | |
| Principal Investigator: Sanjiv Modi, MD | |
| United States, Michigan | |
| Michigan State University, Breslin Cancer Center | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Principal Investigator: Anas Al-Janadi, MD | |
| Newland Medical Associates | Recruiting |
| Southfield, Michigan, United States, 48075 | |
| Principal Investigator: Robert Bloom, MD | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Principal Investigator: Joseph Jurcic, MD | |
| United States, Ohio | |
| Cleveland Clinic Foundation | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: Mikkael Sekeres, MD | |
| United States, Texas | |
| University of Texas, MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Gautam Borthakur, MD | |
| United States, Wisconsin | |
| Gunderson Clinic | Recruiting |
| La Crosse, Wisconsin, United States, 54601 | |
| Principal Investigator: Ronald Go, MD | |
| Study Director: | Eric Sievers, MD | Seattle Genetics, Inc. |
More Information
| Responsible Party: | Seattle Genetics, Inc. ( Eric Sievers, MD, Sr. Medical Director ) |
| Study ID Numbers: | SG033-0003 |
| Study First Received: | September 10, 2007 |
| Last Updated: | August 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00528333 |
| Health Authority: | United States: Food and Drug Administration |
|
Lintuzumab Antigens, CD33 Antibodies, Monoclonal |
Leukemia, Myeloid, Acute Hematologic Diseases Leukemia |
|
Antibodies, Monoclonal Leukemia Antibodies Hematologic Diseases Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myeloid, Acute Acute myelocytic leukemia Cytarabine Immunoglobulins |
|
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents |
Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses |
