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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00631059
• Other study ID #: UCI 07-46
• Secondary ID: HS# 2007-6051
• Status: Terminated
• Phase: N/A
• First received: February 27, 2008
• Last updated: October 11, 2010
• Start date: March 2008
• Est. completion date: June 2010

Study information

• Verified date: October 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Irvine	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology		No Projected Closing Date	No
Secondary	To develop a body of evidence from acute leukemia patients that demonstrates the applicability of the Hem(A)+ assay		No Projected Closing Date	No