A Phase II Study of Iressa (Gefitinib), in Patients With Relapsed or Refractory Acute Myelogenous Leukemia and in Older Patients With Newly Diagnosed Acute Myelogenous Leukemia
Patients will receive Iressa daily until either disease progression or intolerable toxicity
develops. On Day 1 of treatment, a physical exam and bloodwork will be performed. Once
weekly for the first 8 weeks, a physical exam and complete blood count with differential
will be performed.
For the first year, a physical exam, bloodwork will be performed monthly. Bone marrow
biopsies will be performed after the first month of therapy and then every 3 months for the
first year. After the first year a physical exam, bloodwork will be performed every 3 months
and bone marrow biopsies every 6 months.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the response rate of Iressa in patients with acute myelogenous leukemia
Daniel J DeAngelo, MD, PhD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|