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Tracking Information | |||||
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First Received Date ICMJE | February 27, 2008 | ||||
Last Updated Date | October 11, 2010 | ||||
Start Date ICMJE | March 2008 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00631059 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients | ||||
Official Title ICMJE | Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients | ||||
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 |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Leukemia | ||||
Intervention ICMJE | 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. |
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Study Arms | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Estimated Enrollment ICMJE | 40 | ||||
Completion Date | June 2010 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria: Newly Diagnosed Subjects
Relapsed Subjects
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00631059 | ||||
Other Study ID Numbers ICMJE | UCI 07-46, HS# 2007-6051 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Leonard Sender, M.D., Chao Family Comprehensive Cancer Center | ||||
Study Sponsor ICMJE | University of California, Irvine | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | University of California, Irvine | ||||
Verification Date | October 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |