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A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia, Myelodysplastic Syndrome, Myeloproliferative Disorders, Chronic Myelomonocytic Leukemia

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Trial Information

A Phase 1, Multi-Dose Study of SGN-33 (Anti-huCD33 mAb; HuM195; Lintuzumab) in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The incidence of adverse events and lab abnormalities.

Outcome Time Frame:

13 months

Safety Issue:

Yes

Principal Investigator

Eric Sievers, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SG033-0001

NCT ID:

NCT00283114

Start Date:

November 2005

Completion Date:

January 2010

Related Keywords:

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • Myeloproliferative Disorders
  • Chronic Myelomonocytic Leukemia
  • Lintuzumab
  • Antigens, CD33
  • Antibodies, Monoclonal
  • Leukemia, Myeloid, Acute
  • Myelodysplastic Syndromes
  • Hematologic Diseases
  • Myeloproliferative Disorders
  • Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelomonocytic, Chronic
  • Myelodysplastic Syndromes
  • Preleukemia
  • Leukemia, Myelomonocytic, Acute
  • Myeloproliferative Disorders

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021
Weill Medical College of Cornell University New York, New York  10021
Rocky Mountain Cancer Center Denver, Colorado  80218
St. Vincent's Comprehensive Cancer Center New York, New York  10011
Scott & White Memorial Hospital Temple,, Texas  76508
Cancer Center of the Carolinas Greenville, South Carolina  29615
Cancer Care Specialists of Central Illinois Decatur, Illinois  62256
Indiana Oncology-Hematology Consultants Indianapolis, Indiana  46107
University of Massachusetts Medical Center Worcester, Massachusetts  01605