Study of Iressa in Patients With Relapsed or Refractory Acute Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00130702|
Recruitment Status : Completed
First Posted : August 16, 2005
Last Update Posted : May 1, 2014
|Condition or disease||Intervention/treatment||Phase|
|Myelogenous Leukemia, Acute||Drug: gefitinib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
Experimental: Gefitinib (Iressa)
All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.
gefitinib (Iressa) at a dose of 750 mg, once per day
Other Name: Iressa
- To determine the response rate of Iressa in patients with acute myelogenous leukemia
- To determine the safety of Iressa in patients with acute myelogenous leukemia [ Time Frame: 2 years ]
- to determine the biologic activity of Iressa in patients with acute myelogenous leukemia [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130702
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Daniel J DeAngelo, MD, PhD||Dana-Farber Cancer Institute|