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Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia

NCT01174043•Indiana University

View on ClinicalTrials.gov

Summary

This research study is looking for patients with newly diagnosed acute myeloid leukemia (AML), AML that has returned (relapsed), or it has not responded adequately to previous treatments. Treating certain patients with chemotherapy may not be to their benefit or may cause more harm than benefit. The purpose of this study is to find out what effects (good and bad) erlotinib has on patients and their AML.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of AML with no history of previous clonal/malignant hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
•Newly diagnosed patients will be age 70 or older
•Relapses patients will be age 60 or older any time following first relapse, if patient is not considered candidate/not interested in salvage chemotherapy.
•Refractory disease patients will be age 18-59 who have failed at least 2 lines of conventional chemotherapy (1 induction and 1 salvage)
•Patient must have discontinued all previous therapies for AML at least 14 days and recovered from the non-hematologic side effects of the therapy.
•Laboratory tests must be within protocol-specified ranges
•Patient must be able to swallow and tolerate oral medication.

Exclusion Criteria

•Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging.
•History of antecedent pre-leukemic hematologic disorders such as myelodysplastic syndromes or myeloproliferative disorders.
•Diagnosis of acute promyelocytic leukemia (APL)
•Patients with active corneal erosions or history of abnormal corneal sensitivity test.
•Patients with serious illness such as: significant ongoing or active infection, New York Heart Association (NYHA) Grade II or greater congestive heart failure, unstable angina (anginal symptoms at rest), new onset angina (began within the last 3 months), myocardial infarction within the past 6 months, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy, cerebrovascular accident within past 3 months, or psychiatric illness that would limit compliance with the study requirements.

Locations (1)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Key Dates

Start Date

July 1, 2010

Primary Completion Date

March 1, 2012

Completion Date

March 1, 2012

Last Updated

October 13, 2023

Enrollment

ACTUAL participants

Conditions

Leukemia, Myelomonocytic, Acute

Interventions

Erlotinib

DRUG

A Study of Volasertib Plus Induction Chemotherapy for Acute Myeloid Leukemia

NCT02527174

Leukemia, Myeloid, AcuteLeukemia, Monocytic, Acute+3 more

View study

COMPLETEDPHASE1/PHASE2

Study of XIAP Antisense Given With Chemotherapy for Refractory/Relapsed AML

NCT00363974

Leukemia, Myelomonocytic, Acute

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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