At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of CLL/SLL confirmed by WHO classification
- ✓Low-risk (Rai stage 0), intermediate-risk (Rai stages I–II with evidence of active disease), or high-risk (Rai stages III–IV) by Modified Three-Stage Rai Staging System
- ✓Age ≥18 years
- ✓No prior cytotoxic or monoclonal antibody therapy
- ✕Pregnant or breastfeeding
- ✕Active autoimmune hemolytic anemia (AIHA) grade III or higher (requiring transfusion or steroids) or immune thrombocytopenia (ITP) grade III or higher (platelets <50,000/μL)
- ✕Medical condition requiring chronic corticosteroid use
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): DNA Microarray Gene Expression Analysis
In Brief
A Phase 2 clinical trial evaluating Rituximab, Fludarabine phosphate, and 1 other intervention for Chronic Lymphocytic Leukemia. Completed, enrolled 105 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Rituxan
Fludara
Patients are eligible to donate cells for the purpose of analyzing leukemic cells. Cells can be donated by apheresis (e.g. 60-90 minute intravenous technique), lymph node biopsy (e.g. 3 biopsy/excision of lymph nodes)bone marrow biopsy (e.g. 2-4 separate bone marrow biopsies), and bone marrow aspiration (e.g. 3 to 5cc of marrow per aspirate).