A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
This study has been completed.
Sponsor:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00283114
First received: January 25, 2006
Last updated: October 7, 2011
Last verified: October 2011
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Purpose
Phase 1a is an open-label, multi-dose, single-arm, dose-escalation study to define the toxicity profile, pharmacokinetics, and antitumor activity of SGN-33 in patients with myelodysplastic syndrome (MDS), acute myelogenous leukemia(AML), and CD33+ myeloproliferative diseases. Phase 1b includes patients with AML or MDS treated at the highest tolerated dose from phase 1a.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myeloid Leukemia Myelodysplastic Syndrome Myeloproliferative Disorders Chronic Myelomonocytic Leukemia |
Drug: lintuzumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Blood Disorders
Leukemia
Myelodysplastic Syndromes
U.S. FDA Resources
Further study details as provided by Seattle Genetics, Inc.:
Primary Outcome Measures:
- The incidence of adverse events and lab abnormalities. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
- Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA). [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
- Antitumor activity. [ Time Frame: 13 months ] [ Designated as safety issue: No ]
| Enrollment: | 82 |
| Study Start Date: | November 2005 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: lintuzumab
1.5 - 8 mg/kg IV (in the vein) on Days 1, 8, 15, 22 and 29 of Cycle 1; 1.5 - 8 mg/kg IV (in the vein) every other week for all subsequent cycles
Other Name: SGN-33
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must have a diagnosis of MDS or AML.
- Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.
Exclusion Criteria:
- Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
- Patients with a prior allogeneic transplant.
- Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
- Patients receiving chemotherapy within the last four weeks.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00283114
Locations
| United States, Colorado | |
| Rocky Mountain Cancer Center | |
| Denver, Colorado, United States, 80218 | |
| United States, Illinois | |
| Cancer Care Specialists of Central Illinois | |
| Decatur, Illinois, United States, 62526 | |
| United States, Indiana | |
| Indiana Oncology-Hematology Consultants | |
| Indianapolis, Indiana, United States, 46107 | |
| United States, Massachusetts | |
| University of Massachusetts Medical Center | |
| Worcester, Massachusetts, United States, 01605 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| St. Vincent's Comprehensive Cancer Center | |
| New York, New York, United States, 10011 | |
| United States, South Carolina | |
| Cancer Center of the Carolinas | |
| Greenville, South Carolina, United States, 29605 | |
| United States, Texas | |
| Scott & White Memorial Hospital | |
| Temple, Texas, United States, 76508 | |
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
| Study Director: | Eric Sievers, M.D. | Seattle Genetics, Inc. |
More Information
No publications provided
| Responsible Party: | Seattle Genetics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00283114 History of Changes |
| Other Study ID Numbers: | SG033-0001 |
| Study First Received: | January 25, 2006 |
| 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 |
Myelodysplastic Syndromes Hematologic Diseases Myeloproliferative Disorders Leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelomonocytic, Chronic Myelodysplastic Syndromes Preleukemia Leukemia, Myelomonocytic, Acute |
Myeloproliferative Disorders Neoplasms by Histologic Type Neoplasms Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on May 16, 2013