A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Sponsor study identifier
interventional
82
1 country
9
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
January 25, 2006
Actual (reported)January 27, 2006
Actual (reported)January 2010
Actual (reported)January 2010
Actual (reported)The incidence of adverse events and lab abnormalities.
13 months
Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA).
13 months
Antitumor activity.
13 months
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rocky Mountain Cancer Center
Denver, Colorado, 80218, United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526, United States
Indiana Oncology-Hematology Consultants
Indianapolis, Indiana, 46107, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, 01605, United States
St. Vincent's Comprehensive Cancer Center
New York, New York, 10011, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021, United States
Weill Medical College of Cornell University
Raza A, Jurcic JG, Roboz GJ, Maris M, Stephenson JJ, Wood BL, Feldman EJ, Galili N, Grove LE, Drachman JG, Sievers EL. Complete remissions observed in acute myeloid leukemia following prolonged exposure to lintuzumab: a phase 1 trial. Leuk Lymphoma. 2009 Aug;50(8):1336-44. doi: 10.1080/10428190903050013.
Eric Sievers, M.D.
Seagen Inc.
82 participants (actual enrollment reported by the registry).
First Submitted
January 25, 2006
First Posted
January 27, 2006
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
New York, New York, 10021, United States
Cancer Center of the Carolinas
Greenville, South Carolina, 29605, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Primary Completion
January 2010
Actual (reported)Study Completion
January 2010
Actual (reported)Last Updated
December 18, 2014
Record last verified: 2014-12
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Source: ClinicalTrials.gov.
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