Status:
TERMINATED
Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients
Lead Sponsor:
University of California, Irvine
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
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 relap...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00631059
Start Date
March 1 2008
End Date
June 1 2010
Last Update
October 13 2010
Active Locations (1)
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1
University of California, Irvine
Orange, California, United States, 92868