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

Primary Purpose

Leukemia, Myelomonocytic, Acute

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Myelomonocytic, Acute focused on measuring Leukemia, Myelomonocytic, Acute, Erlotinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 who require chronic anticoagulation, are current smokers or who are taking rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort are not eligible.
  • 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.

Sites / Locations

  • Indiana University Melvin and Bren Simon Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erlotinib

Arm Description

Outcomes

Primary Outcome Measures

Overall Response Rate (Defined as Partial Remission or Better) to 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.

Secondary Outcome Measures

Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission
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
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.

Full Information

First Posted
July 30, 2010
Last Updated
October 11, 2023
Sponsor
Indiana University
Collaborators
OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01174043
Brief Title
Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia
Official Title
Pilot Study of Erlotinib for the Treatment of Patients With de Novo Acute Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University
Collaborators
OSI Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelomonocytic, Acute
Keywords
Leukemia, Myelomonocytic, Acute, Erlotinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erlotinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Response Rate (Defined as Partial Remission or Better) to 3 Months of Treatment With Erlotinib
Description
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.
Time Frame
3 months of treatment with erlotinib
Secondary Outcome Measure Information:
Title
Duration of Response (up to One Year Follow up) in Patients Who Achieve a Complete Remission
Description
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.
Time Frame
1 year after treatment discontinuation
Title
Treatment Related Adverse Events Grade 3 or Higher
Description
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.
Time Frame
up to 15 months
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 who require chronic anticoagulation, are current smokers or who are taking rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort are not eligible. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
S. Hamid Sayar, MD
Organizational Affiliation
Indiana University Melvin and Bren Simon Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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

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