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

Study Overview
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Brief Summary
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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

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

Conditions
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Leukemia

Intervention / Treatment
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* Other: Hem(A)+ Technology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | No Projected Closing Date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hitachi, Leukemia, Relapse, Chemotherapy Resistance