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NCT00363779 · ClinicalTrials.gov registry record · Phase 2
Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00363779: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00363779 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00363779, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Background: * Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma. * LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding). * Cyclosporine (CSA) is an immunosuppressive drug that improves low blood cell counts in about 50 percent of patients with LGL leukemia. Objectives: * To identify what factors determine why cyclosporine works in some patients and not in others. * To identify what causes low blood counts in LGL leukemia. Eligibility: Patients 18 years of age and older with LGL leukemia. Design: * Patients have a medical history, physical examination blood tests, bone marrow biopsy and x-ray studies, including chest x-rays and computed tomography (CT) scans of the chest, abdomen and pelvis. Patients with an easily accessible enlarged lymph node have a node biopsy (removal of a small piece of tissue for microscopic examination). * Patients take cyclosporine twice a day by mouth. Blood samples are taken at least weekly to adjust the cyclosporine dosing to maintain therapeutic serum levels. * Patients undergo apheresis (collection of white blood cells) at a number of different time points in the study (maximum 6 times) to look at the differences in the leukemia cells before and during treatment with cyclosporine. For apheresis, blood is withdrawn through a needle in an arm vein and directed through a catheter (plastic tube) into a machine that separates it into its components. The white cells are extracted and the rest of the blood is returned through the same needle or through a second needle in the other arm.
Interventions
- DRUG Cyclosporine
- OTHER Laboratory biomarker analysis
- GENETIC Microarray analysis
- GENETIC Gene expression analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2006-06 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00363779
The ClinicalTrials.gov registry entry for NCT00363779 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclosporine is the first listed.
NCT00363779 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00363779 about?
NCT00363779 is a clinical study titled "Effect of Cyclosporine Therapy on Gene Expression in Patients With Large Granular Lymphocyte Leukemia". Background: * Large granular lymphocyte (LGL) leukemia is a low-grade non-Hodgkin's lymphoma. * LGL is associated with low numbers of white blood cells (leading to recurring infections), red blood cells (causing anemia) and platelets (causing abnormal bleeding). * Cyclosporine (CSA) is an immunosup...
What is the current status of trial NCT00363779?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2006-06. Estimated completion is 2010-11.
What interventions are being tested in trial NCT00363779?
The interventions under investigation include: Cyclosporine (DRUG), Laboratory biomarker analysis (OTHER), Microarray analysis (GENETIC), Gene expression analysis (GENETIC).
Who is sponsoring clinical trial NCT00363779?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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