Clinical trial · Interventional
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
NCT00130702CI-TRIAL-00014388completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine how effective, and to what extent, Iressa is in the treatment of acute myelogenous leukemia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myelogenous Leukemia, Acute | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gefitinib (Iressa)
- description
- All patients will receive Gefitinib (Iressa) at a dose of 750 mg orally (three 250 mg tabs) each day.
- interventionNames
- Drug: gefitinib
Primary outcomes (1)
- measure
- To determine the response rate of Iressa in patients with acute myelogenous leukemia
Secondary outcomes (2)
- measure
- To determine the safety of Iressa in patients with acute myelogenous leukemia
- timeFrame
- 2 years
- measure
- to determine the biologic activity of Iressa in patients with acute myelogenous leukemia
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.