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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00283114
First received: January 25, 2006
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Disorders
Chronic Myelomonocytic Leukemia
Drug: lintuzumab
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • The incidence of adverse events and lab abnormalities. [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic (PK) profile and immunogenicity (Human Anti-Human Antibody; HAHA). [ Time Frame: 13 months ] [ Designated as safety issue: Yes ]
  • Antitumor activity. [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: November 2005
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00283114

Locations
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
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
St. Vincent's Comprehensive Cancer Center
New York, New York, United States, 10011
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
Seattle Genetics, Inc.
Investigators
Study Director: Eric Sievers, M.D. Seattle Genetics, Inc.
  More Information

Publications:
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT00283114     History of Changes
Other Study ID Numbers: SG033-0001
Study First Received: January 25, 2006
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Lintuzumab
Antigens, CD33
Antibodies, Monoclonal
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Hematologic Diseases
Myeloproliferative Disorders
Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, Myelomonocytic, Acute
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Myeloproliferative Disorders
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Myelodysplastic-Myeloproliferative Diseases
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on October 29, 2014