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

Sponsor

University of California, Irvine (Other)

Overall Status

Terminated

CT.gov ID

NCT00631059

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Leukemia	Other: Hem(A)+ Technology	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

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

Study Start Date :

Mar 1, 2008

Actual Study Completion Date :

Jun 1, 2010

Outcome Measures

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 [No Projected Closing Date]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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