Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia
NCT01269385 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2020-06-23
Summary
RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can kill chronic lymphocytic leukemia (CLL) cells and are effective therapies for this disease. Biological therapies, such as Imprime PGG (poly-(1-6)-beta-glucotriosyl-(1-3)-beta-glucopyranose), may stimulate the immune system in different ways and help monoclonal antibodies kill CLL cells. Giving PGG beta-glucan together with alemtuzumab and rituximab could make therapy with monoclonal antibodies, such as alemtuzumab and rituximab, more effective.
PURPOSE: This phase I/II trial is studying the side effects and best dose of PGG beta-glucan when given together with alemtuzumab and rituximab and to see how well it works in treating patients with earlier stage high-risk chronic lymphocytic leukemia.
Conditions
- B-cell Chronic Lymphocytic Leukemia
- Refractory Chronic Lymphocytic Leukemia
- Stage 0 Chronic Lymphocytic Leukemia
- Stage I Chronic Lymphocytic Leukemia
- Stage II Chronic Lymphocytic Leukemia
Interventions
- BIOLOGICAL
-
alemtuzumab
Given subcutaneously
- BIOLOGICAL
-
Given IV
- DRUG
-
PGG beta-glucan
Given IV
- OTHER
-
flow cytometry
Correlative studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
- GENETIC
-
DNA analysis
Correlative studies
- GENETIC
-
fluorescence in situ hybridization
Correlative studies
- GENETIC
-
polymerase chain reaction
Correlative studies
- GENETIC
-
polymorphism analysis
Correlative studies
- GENETIC
-
mutation analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH - lead OTHER
Principal Investigators
-
Steven Ansell, M.D. · Mayo Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2014-06-30
- Completion
- 2015-06-30
Countries
- United States
Study Locations
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