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
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 15, 2005
CompletedFirst Posted
Study publicly available on registry
August 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedMay 1, 2014
April 1, 2014
2.3 years
August 15, 2005
April 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the response rate of Iressa in patients with acute myelogenous leukemia
Secondary Outcomes (2)
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
Study Arms (1)
Gefitinib (Iressa)
EXPERIMENTALAll patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.
Interventions
gefitinib (Iressa) at a dose of 750 mg, once per day
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Boston Children's Hospitalcollaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel J DeAngelo, MD, PhD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 15, 2005
First Posted
August 16, 2005
Study Start
August 1, 2005
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
May 1, 2014
Record last verified: 2014-04