At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of B-cell chronic lymphocytic leukemia
- ✓Absolute lymphocytosis greater than 5,000/μL
- ✓Mature lymphocytes with less than 55% prolymphocytes
- ✓Bone marrow involvement documented by aspirate (>30% lymphoid cells) or biopsy compatible with CLL involvement; normocellular or hypercellular
- ✕Any prior therapy for CLL, including corticosteroids for autoimmune complications since initial CLL diagnosis
- ✕Medical condition requiring chronic oral corticosteroids
- ✕HIV infection
- ✕Pregnancy or nursing status; women and men of reproductive potential must use effective birth control
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Study of Fludarabine + Rituximab Induction Followed by Alemtuzumab (Campath-1H, NSC #715969, IND #10864) Administered Subcutaneously as Consolidation in Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating alemtuzumab, rituximab, and 1 other intervention for B-cell Chronic Lymphocytic Leukemia and 4 related conditions. Completed, enrolled 102 participants across 2 sites.
Detailed Summary
This phase II trial is studying how well giving fludarabine together with rituximab followed by alemtuzumab works in treating patients with chronic lymphocytic leukemia. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others can find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving fludarabine together with rituximab followed by alemtuzumab may kill more cancer cells.
Study Details
Timeline
Interventions
Given SC
Given IV
Given IV