NCT00130702

Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.

Detailed description

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.

Conditions

• Myelogenous Leukemia, Acute

Interventions

Type	Name	Description
DRUG	gefitinib	gefitinib (Iressa) at a dose of 750 mg, once per day

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2005-08-16
• Last updated: 2014-05-01

Locations

1 site across 1 country: United States