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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Indiana University

Current Primary Outcome: 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.


Original Primary Outcome: Evaluate overall response (defined as partial remission or better) to 3 months of treatment with erlotinib [ Time Frame: 3 months of treatment with erlotinib ]

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Evaluate the duration of response (up to one year follow up) in patients who achieve a complete remission [ Time Frame: 1 year after treatment discontinuation ]

Information By: Indiana University

Dates:
Date Received: July 30, 2010
Date Started: July 2010
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015