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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
Not Enrolling
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:


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:


Principal Investigator

Eric Sievers, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.


United States: Food and Drug Administration

Study ID:




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



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