Expired Study
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Orange, California 92868


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


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


Study is Available At:


Original ID:

UCI 07-46


NCT ID:

NCT00631059


Secondary ID:

HS# 2007-6051


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Irvine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Haluted due to slow accrual


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:March 2008
Completion Date:June 2010
Completion Type:Actual
Verification Date:October 2010
Last Changed Date:October 11, 2010
First Received Date:February 27, 2008

Study Outcomes

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

Study Interventions

Intervention Type:Other
Name:Hem(A)+ Technology
Description:The purpose of the study is to test patients blood. A blood draw will be taken and examined with Hem(A)+ technology.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Irvine

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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