- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01581528
Studying Samples From Patients With T-Cell Acute Lymphoblastic Leukemia
Metabolic Pathways in T-Cell Acute Lymphoblastic Leukemia (T-ALL)
RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors identify learn more about biomarkers related to cancer. It may also help doctors to find better ways to treat cancer.
PURPOSE: This research studies samples from patients with T-cell acute lymphoblastic leukemia (T-ALL).
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- Determine the metabolic status and regulation of primary T-cell acute lymphoblastic leukemia (T-ALL) relative to control resting peripheral T cells.
- Establish the effects of metabolic inhibition on metabolic stress pathways and apoptosis.
- Determine how metabolic inhibition interacts with chemotherapy or targeted therapy drugs to kill T-ALL cells.
OUTLINE: T-ALL samples cultured alone or with gamma secretase inhibitors (GSI) or PI3K inhibitors are analyzed for metabolic characteristics including glucose transporter 1 (Glut1) expression, mitochondrial mass, phospho-flow for 5' adenosine monophosphate-activated protein kinase (AMPK), acetyl-CoA carboxylase (ACC), and mammalian target of rapamycin (mTOR) by flow cytometry. T-ALL samples and normal CD4+ T cells (control) are also exposed to ± 2-deoxyglucose or ± the glutaminolysis inhibitor media and analyzed for metabolic stress responses over time in particular, AMPK activation, autophagy (immunofluorescence for LC3-II processing), and BCL2-associated X protein (Bak) and Bax activation to indicate apoptosis. These cells (T-ALL and control) are then cultured with cyclophosphamide, dexamethasone, or the B-cell CLL/lymphoma 2 (Bcl-2) inhibitor, ABT-737, to determine cell death over time.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- Sample from patients diagnosed with T-ALL
- Samples from independent healthy donors obtained through the Gulf Coast Regional Blood Center (controls)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Metabolic status of primary T-ALL
|
Effects of metabolic inhibition on metabolic stress pathways and apoptosis
|
Metabolic inhibition interaction with chemotherapy or targeted drugs
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeffrey C. Rathmell, PhD, Duke Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary 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
- AALL12B5 (OTHER: Children's Oncology Group)
- COG-AALL12B5 (OTHER: clinicaltrials.gov)
- NCI-2012-00728 (REGISTRY: CTRP (Clinical Trial Reporting Program))
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.
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