Phase II Trial With a Recombinant Humanized Anti-CD33 Monoclonal Antibody (HuM195) in Patients With High Risk Primary Myelodysplastic Syndromes
OBJECTIVES: I. Assess the therapeutic activity of monoclonal antibody HuG1-M195 on
peripheral blood and bone marrow blast cell count, blood leukocyte, reticulocyte, and
platelet counts, and hemoglobin levels in patients with myelodysplastic syndrome with
refractory anemia with excess blasts (RAEB) (greater than 10% bone marrow myeloblasts) or
RAEB in transformation. II. Assess the efficacy of this drug in terms of duration of
response in these patients. III. Evaluate the toxicity of this drug in these patients.
OUTLINE: Patients receive monoclonal antibody HuG1-M195 IV over 4 hours on days 1-4.
Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or
unacceptable toxicity. Patients with progressive disease after 2 courses are removed from
study. Patients with stable disease receive no further treatment after 4 courses. Patients
with complete or partial response receive treatment for 4 additional courses. Patients are
followed at 11 and 39 days after end of course 4, monthly for 4 months, then every 3 months
thereafter for 1 year from study entry.
PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
Primary Purpose: Treatment
Heinz Zwierzina, MD
Medical University Innsbruck
United States: Federal Government