Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT01174043|
Recruitment Status : Completed
First Posted : August 3, 2010
Results First Posted : March 27, 2015
Last Update Posted : March 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Myelomonocytic, Acute||Drug: Erlotinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
- Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib [ Time Frame: 3 months of treatment with erlotinib ]The percent of patients were shown as having a partial remission or better based on definitions of response in AML. Partial remission includes a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. The percent and 95% exact confidence intervals will be calculated.
- Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission [ Time Frame: 1 year after treatment discontinuation ]The duration of response is from the time of response until failure or until the end of follow-up for the patients who received complete remission. Complete remission includes presence of less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells.
- Treatment Related Adverse Events Grade 3 or Higher [ Time Frame: up to 15 months ]Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Grading scale will be from 1 (mild) to 5 (causing death). This will determine the number of unique patients who had a treatment related (possible, probable or definite) adverse event that was graded 3 or greater.
- Mechanistic Attributes of Erlotinib Hydrochloride in AML, Including Intracellular Quantitative Protein and Gene Expression Modifications and the in Vivo Effect of This Agent on the Differentiation of AML Blasts [ Time Frame: Baseline; days 3, 4, 8, and 29 of course 1; and day 29 of courses 3, 6, 9, and 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01174043
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||S. Hamid Sayar, MD||Indiana University Melvin and Bren Simon Cancer Center|