- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00283114
A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
December 17, 2014 updated by: Seagen Inc.
A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
82
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Colorado
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Center
-
-
Illinois
-
Decatur, Illinois, United States, 62526
- Cancer Care Specialists of Central Illinois
-
-
Indiana
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Indianapolis, Indiana, United States, 46107
- Indiana Oncology-Hematology Consultants
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Massachusetts
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Worcester, Massachusetts, United States, 01605
- University of Massachusetts Medical Center
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New York
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New York, New York, United States, 10021
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10021
- Weill Medical College of Cornell University
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New York, New York, United States, 10011
- St. Vincent's Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, United States, 29605
- Cancer Center Of The Carolinas
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Texas
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Temple, Texas, United States, 76508
- Scott & White Memorial Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of adverse events and lab abnormalities.
Time Frame: 13 months
|
13 months
|
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
Time Frame: 13 months
|
13 months
|
Antitumor activity.
Time Frame: 13 months
|
13 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Eric Sievers, M.D., Seagen Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
January 25, 2006
First Submitted That Met QC Criteria
January 25, 2006
First Posted (Estimate)
January 27, 2006
Study Record Updates
Last Update Posted (Estimate)
December 18, 2014
Last Update Submitted That Met QC Criteria
December 17, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Myelodysplastic-Myeloproliferative Diseases
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myeloid, Acute
- Preleukemia
- Leukemia, Myelomonocytic, Chronic
- Leukemia, Myelomonocytic, Juvenile
- Myeloproliferative Disorders
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Lintuzumab
Other Study ID Numbers
- SG033-0001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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