At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Antibody Therapy With Alemtuzumab, Rituximab and GM-CSF for Initial Treatment of High Risk Chronic Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating Alemtuzumab, Rituximab, and 1 other intervention for Leukemia. Completed, enrolled 33 participants across 2 sites.
Detailed Summary
RATIONALE: 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 find cancer cells and help kill them or carry cancer-killing substances to them. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving monoclonal antibody therapy together with GM-CSF may be an effective treatment for early-stage chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying the side effects of giving rituximab and alemtuzumab together with GM-CSF and to see how well it works in treating patients with early-stage chronic lymphocytic leukemia.
Study Details
Timeline
Interventions
Week 1 (dose escalation): Day 3: 3mg subcutaneously; Day 4: 10mg subcutaneously; Day 5 30mg subcutaneously Weeks 2-5: 30mg subcutaneously three times a week.
Weeks 2-5: 375 mg/m\^2 by IV once weekly
Week 1-6: 250 mcg subcutaneously three time as week