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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00283114
Recruitment Status : Completed
First Posted : January 27, 2006
Last Update Posted : December 18, 2014
Information provided by (Responsible Party):
Seagen Inc.

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 (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 or disease Intervention/treatment Phase
Acute Myeloid Leukemia Myelodysplastic Syndrome Myeloproliferative Disorders Chronic Myelomonocytic Leukemia Drug: lintuzumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2005
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The incidence of adverse events and lab abnormalities. [ Time Frame: 13 months ]
  2. Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA). [ Time Frame: 13 months ]
  3. Antitumor activity. [ Time Frame: 13 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who have received prior therapy with gemtuzumab ozogamicin (Mylotarg®) or other anti-CD33 monoclonal antibody treatment.
  2. Patients with a prior allogeneic transplant.
  3. Patients with known leptomeningeal or CNS involvement of leukemia. Patients with onset of CNS symptoms within the past 12 months will also be excluded.
  4. Patients receiving chemotherapy within the last four weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00283114

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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
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
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
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
Seagen Inc.
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Study Director: Eric Sievers, M.D. Seagen Inc.
Publications of Results:
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Responsible Party: Seagen Inc. Identifier: NCT00283114    
Other Study ID Numbers: SG033-0001
First Posted: January 27, 2006    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Keywords provided by Seagen Inc.:
Antigens, CD33
Antibodies, Monoclonal
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Hematologic Diseases
Myeloproliferative Disorders
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Chronic
Leukemia, Myelomonocytic, Juvenile
Myelodysplastic Syndromes
Myeloproliferative Disorders
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Myelodysplastic-Myeloproliferative Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents