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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00130702

Enrollment

Registered

2005-08-16

Start date

2005-08-31

Completion date

2007-11-30

Last updated

2014-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelogenous Leukemia, Acute

Keywords

AML, acute myelogenous leukemia, gefitinib, Iressa

Brief 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.

Interventions

DRUGgefitinib

gefitinib (Iressa) at a dose of 750 mg, once per day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients must have pathologically documented acute myelogenous leukemia and either not be a candidate for myelosuppressive chemotherapy due to age or comorbid disease; or have relapsed acute myelogenous leukemia or be refractory to standard therapy and not likely to require cytoreductive therapy within 30 days. * ECOG performance status 0, 1 or 2 * Age \> 18 years * Adequate kidney and hepatic function * Greater than 4 weeks from any chemotherapy, radiotherapy, immunotherapy, or systemic steroid therapy with the exception of hydroxyurea. * Greater than 2 months following bone marrow or peripheral blood stem cell transplantation or donor lymphocyte infusion.

Exclusion criteria

* Uncontrolled active infection * Urgent need for cytoreductive chemotherapy, surgery, or radiotherapy * Current chemotherapy or chemotherapy within the last 4 weeks. * Pregnancy or nursing mothers * Infection with HIV

Design outcomes

Primary

Measure	Time frame
To determine the response rate of Iressa in patients with acute myelogenous leukemia	—

Secondary

Measure	Time frame
To determine the safety of Iressa in patients with acute myelogenous leukemia	2 years
to determine the biologic activity of Iressa in patients with acute myelogenous leukemia	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026