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

October 11, 2010 updated by: University of California, Irvine

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

Study Overview

Status

Terminated

Conditions

Leukemia

Intervention / Treatment

Other: Hem(A)+ Technology

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Orange, California, United States, 92868
    - University of California, Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	No Projected Closing Date

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology Time Frame: No Projected Closing Date	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	No Projected Closing Date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Investigators

Principal Investigator: Leonard S. Sender, MD, UCI Department of Medicine -- Hematology/Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria