A Safety Study of Lintuzumab in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Completed · Phase 1

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia

In brief

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.

Key facts

Study ID

NCT00283114

Run by

Seagen Inc.

People needed

82

Starts

2005-11-01

Expected to finish

2010-01-01

Last updated by the study team

2014-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a diagnosis of MDS or AML.
• Patients must have an ECOG performance status ≤ 2 and a life expectancy > 3 months.

You may not qualify if…

• 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.

Where it is running

• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Cancer Care Specialists of Central Illinois — Decatur, Illinois, United States
• Indiana Oncology-Hematology Consultants — Indianapolis, Indiana, United States
• University of Massachusetts Medical Center — Worcester, Massachusetts, United States
• St. Vincent's Comprehensive Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• Cancer Center of the Carolinas — Greenville, South Carolina, United States
• Scott & White Memorial Hospital — Temple, Texas, United States

Full record on ClinicalTrials.gov

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