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NCT00001586 · ClinicalTrials.gov registry record · Phase 2
Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 105
- Enrollment target
NCT00001586: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00001586 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 105 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001586, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 105 participants
- Enrollment target
Study Summary
Background: * Combined therapy with rituximab and fludarabine is the treatment of choice for advanced stage chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). * A new technology called deoxyribonucleic acid (DNA) microarray can be used to gain knowledge about the genetic basis of CLL/SLL. * Genetic studies of CLL/SLL may improve our understanding of what happens in the disease, help determine which patients are most likely to respond to treatment with fludarabine and rituximab, and identify new treatments. Objectives: -To gain further knowledge about CLL/SLL and the role of rituximab and fludarabine in treating the disease. Eligibility: -Patients 18 years of age and older with low, intermediate or high-risk CLL/SLL. Design: * Patients with low-risk CLL/SLL do not receive treatment, but are followed every 3 to 6 months and donate cells (through apheresis) or lymph nodes, or both, for research purposes. * Patients with intermediate or high-risk CLL/SLL receive standard treatment with rituximab and fludarabine for six 28-day treatment cycles. Rituximab is given on day 1 and fludarabine is given on days 1-5. (For the first cycle only, fludarabine treatment starts on day 2. This delay permits blood sampling on day 1 for the effect of rituximab on white blood cells.) * Laboratory tests and imaging studies are done periodically to monitor drug side effects and the response to treatment. Tests include bone marrow biopsy and aspiration, blood tests and x-rays, including positron emission tomography (PET) and computed tomography (CT) scans.
Interventions
- DRUG Fludarabine phosphate
- BIOLOGICAL Rituximab
- OTHER Leukemic or stroma cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 1997-09 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001586
The ClinicalTrials.gov registry entry for NCT00001586 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 105 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 3 interventions - of which Fludarabine phosphate is the first listed.
NCT00001586 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001586 about?
NCT00001586 is a clinical study titled "Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis". Background: * Combined therapy with rituximab and fludarabine is the treatment of choice for advanced stage chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). * A new technology called deoxyribonucleic acid (DNA) microarray can be used to gain knowledge about the genetic basis of CL...
What is the current status of trial NCT00001586?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 1997-09. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00001586?
The interventions under investigation include: Fludarabine phosphate (DRUG), Rituximab (BIOLOGICAL), Leukemic or stroma cells (OTHER).
Who is sponsoring clinical trial NCT00001586?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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