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

NCT ID: NCT00631059

Last Updated: 2010-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Chao Family Comprehensive Cancer Center

Principal Investigators

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Leonard S. Sender, MD

Role: PRINCIPAL_INVESTIGATOR

UCI Department of Medicine -- Hematology/Oncology

Locations

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University of California, Irvine

Orange, California, United States

Site Status

Countries

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United States

Other Identifiers

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HS# 2007-6051

Identifier Type: -

Identifier Source: secondary_id

UCI 07-46

Identifier Type: -

Identifier Source: org_study_id