Status:
COMPLETED
A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Lead Sponsor:
Seagen Inc.
Conditions:
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 (M...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of MDS or AML.
- Patients must have an ECOG performance status ≤ 2 and a life expectancy \> 3 months.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00283114
Start Date
November 1 2005
End Date
January 1 2010
Last Update
December 18 2014
Active Locations (9)
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1
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
2
Cancer Care Specialists of Central Illinois
Decatur, Illinois, United States, 62526
3
Indiana Oncology-Hematology Consultants
Indianapolis, Indiana, United States, 46107
4
University of Massachusetts Medical Center
Worcester, Massachusetts, United States, 01605