A Phase II Study of Arsenic Trioxide in Patients With Relapsed and/or Refractory Acute Myeloid Leukemia (AML) and Mutated Nucleophosmin 1 (NPM1) Gene
I. Determine the complete remission rate of relapsed and refractory acute myeloid leukemia
(AML) patients with Mutated Nucleophosmin 1 (NPM1) gene.
I. Determine the duration of remission in these patients. II. Determine the in vivo
biological effect of arsenic trioxide in AML with mutated NPM1.
Patients receive arsenic trioxide intravenously (IV) over 1-2 hours daily for up to 45 days.
Patients achieving complete remission, receive arsenic trioxide IV over 1-2 hours daily 5
days a week for 4 weeks. Treatment repeats every 8 weeks for up to 4 courses in the absence
of disease progression or unacceptable toxicity.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of complete remission following arsenic trioxide induction
After 4 weeks of therapy
Bruno de Medeiros
United States: Food and Drug Administration
|Stanford University Cancer Institute||Stanford, California 94305|