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Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients

This study has been terminated.
(Haluted due to slow accrual)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631059
First Posted: March 7, 2008
Last Update Posted: October 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of California, Irvine
  Purpose

The objective of this protocol is to collect leukemia cell specimens from adults (18 years of age) diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse. These specimens, in conjunction with a de-identified data set, will be utilized prospectively to determine potential chemotherapy resistance in this patient population.

The specific aims of this study are as follows:

To collect peripheral blood specimens from patients diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology

To develop a body of evidence from acute leukemia patients that demonstrates the applicability of the Hem(A)+ assay to determine the following:

Predict responders and non-responders to common chemotherapeutic agents Track treatment results and comparison to prediction results from the assay Identify optimal chemotherapy doses for each patient Identify the most efficacious pharmaceutical agent combinations


Condition Intervention
Leukemia Other: Hem(A)+ Technology

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • To collect peripheral blood specimens from patients diagnosed with acute leukemia at time of initial diagnosis and, if applicable, at time of first relapse [ Time Frame: No Projected Closing Date ]

Secondary Outcome Measures:
  • To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology [ Time Frame: No Projected Closing Date ]
  • To develop a body of evidence from acute leukemia patients that demonstrates the applicability of the Hem(A)+ assay [ Time Frame: No Projected Closing Date ]

Estimated Enrollment: 40
Study Start Date: March 2008
Study Completion Date: June 2010
Intervention Details:
    Other: Hem(A)+ Technology
    The purpose of the study is to test patients blood. A blood draw will be taken and examined with Hem(A)+ technology.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Newly Diagnosed Subjects

  • The subject is male or female, aged 18 years of age or older
  • The subject has a diagnosis of acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML); the subject must have a pathology-confirmed diagnosis
  • The subject must have a pathology-confirmed diagnosis
  • Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as having >25% blasts in the bone marrow and/or peripheral blood
  • The subject has not received any chemotherapy or treatment for their acute leukemia prior to the initial study visit
  • The subject is able and willing to provide written informed consent
  • The subject is able to understand the study and cooperate with all study instructions

Relapsed Subjects

  • The subject is male or female, aged 18 years of age or older
  • The subject has a diagnosis of relapsed acute lymphocytic leukemia (ALL) or relapsed acute myelogenous leukemia (AML)
  • The subject must have a pathology-confirmed diagnosis
  • Acute lymphocytic leukemia (ALL) or acute myelogenous leukemia (AML) is defined as having ≥ 25% blasts in the bone marrow and/or peripheral blood
  • The subject has received one or more of the pre-identified chemotherapeutic agents for treatment of their initial acute leukemia diagnosis
  • The subject has not received any systemic chemotherapy or treatment for their relapsed acute leukemia
  • Receipt of intrathecal chemotherapy will be permissible
  • The subject is able and willing to provide written informed consent
  • The subject is able to understand the study and cooperate with all study instructions

Exclusion Criteria:

  • The subject has an uncontrolled serious medical or psychiatric illness that, in the opinion of the investigator, would compromise the subject's safety or collection of data
  • The subject received treatment with an investigational drug within two weeks of the initial or subsequent study visits
  • Subjects under the age of 18
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00631059


Locations
United States, California
University of California, Irvine
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Leonard S. Sender, MD UCI Department of Medicine -- Hematology/Oncology
  More Information

Responsible Party: Leonard Sender, M.D., Chao Family Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00631059     History of Changes
Other Study ID Numbers: UCI 07-46
HS# 2007-6051
First Submitted: February 27, 2008
First Posted: March 7, 2008
Last Update Posted: October 13, 2010
Last Verified: October 2010

Keywords provided by University of California, Irvine:
Hitachi
Leukemia
Relapse
Chemotherapy Resistance

Additional relevant MeSH terms:
Leukemia
Recurrence
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes