- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00631059
Assessment and Determination of Chemotherapy Resistance in Newly-Diagnosed or First Relapse Leukemia Patients
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
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Orange, California, United States, 92868
- University of California, Irvine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: No Projected Closing Date
|
No Projected Closing Date
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the leukemia cells in the blood specimens for chemotherapy resistance utilizing the Hem(A)+ technology
Time Frame: No Projected Closing Date
|
No Projected Closing Date
|
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
|
No Projected Closing Date
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leonard S. Sender, MD, UCI Department of Medicine -- Hematology/Oncology
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCI 07-46
- HS# 2007-6051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Leukemia
-
Stanford UniversityTerminatedLeukemia | Leukemia, Lymphocytic, Acute | Leukemia Acute Promyelocytic Leukemia (APL) | Leukemia Acute Lymphoid Leukemia (ALL) | Leukemia Chronic Myelogenous Leukemia (CML) | Leukemia Acute Myeloid Leukemia (AML) | Leukemia Chronic Lymphocytic Leukemia (CLL)United States
-
Massachusetts General HospitalCelgene CorporationTerminatedAcute Myelogenous Leukemia | Acute Myeloid Leukemia (AML) | Acute Myelocytic Leukemia | Acute Granulocytic Leukemia | Acute Non-Lymphocytic LeukemiaUnited States
-
Institute of Hematology & Blood Diseases HospitalBejing Institute for Stem Cell and Regenerative Medicine; Institute for Stem...RecruitingRefractory Leukemia | Relapsed Leukemia | Acute Myeloid Leukemia, ChildhoodChina
-
Betta Pharmaceuticals Co., Ltd.Not yet recruitingAcute Myeloid Leukemia LeukemiaChina
-
Children's Oncology GroupNational Cancer Institute (NCI)CompletedChildhood Acute Monoblastic Leukemia (M5a) | Childhood Acute Monocytic Leukemia (M5b) | Childhood Acute Myeloblastic Leukemia Without Maturation (M1) | Childhood Acute Myelomonocytic Leukemia (M4) | Childhood Acute Myeloid Leukemia/Other Myeloid MalignanciesUnited States
-
Center for International Blood and Marrow Transplant...National Marrow Donor Program; St. Baldrick's FoundationActive, not recruitingAcute Myelogenous LeukemiaUnited States
-
Massachusetts General HospitalCompleted
-
Hybrigenics CorporationUnknownAcute Myelogenous LeukemiaUnited States, France
-
Beijing Boren HospitalRecruitingAcute Myeloid Leukemia | Refractory Acute Myeloid Leukemia | Relapse LeukemiaChina
-
National Cancer Institute (NCI)TerminatedAdult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monocytic Leukemia (M5b) | Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloblastic Leukemia Without Maturation... and other conditionsUnited States
Clinical Trials on Hem(A)+ Technology
-
SynergEyes, Inc.CompletedHypersensitivity | Corneal DiseaseUnited States
-
Stetrix, Inc.CompletedComplications; Cesarean SectionUnited States
-
Desert Perinatal AssociatesCompletedCesarean Section Rate
-
Omron Healthcare Co., Ltd.Biwako Chuo Hospital Japan; Shared Care Research and Education Consulting,....Completed
-
University Hospital OstravaCompletedAcute AppendicitisCzechia
-
Johnson & Johnson Vision Care, Inc.Completed
-
Stetrix, Inc.TerminatedCesarean SectionUnited States
-
Stetrix, Inc.Baptist Memorial Health Care CorporationCompleted
-
University of ChicagoNorthwestern University; Merck Sharp & Dohme LLCCompletedGastric Cancer | Pancreatic Cancer | Lung CancerUnited States
-
He Eye HospitalNot yet recruitingEvaporative Dry EyeChina