Refractory Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Early Treatment of High Risk Chronic Lymphocytic Leukemia With Alemtuzumab, Rituximab, and PGG Beta-Glucan: A Phase I/II Trial
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.
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose of PGG beta glucan in combination with alemtuzumab
and rituximab. (Phase I) II. Assess the rate of complete response of patients with high-risk,
early-intermediate stage CLL who are treated with alemtuzumab, rituximab, and PGG beta glucan
before meeting standard National Cancer Institute-International Workshop on Chronic
Lymphocytic Leukemia (NCI-IWCLL) criteria (Hallek, Cheson et al. 2008) for treatment. (Phase
II)
SECONDARY OBJECTIVES:
I. To monitor and assess toxicity of this regimen. II. Clinical evaluation of toxicity. III.
Serial monitoring of cytomegalovirus (CMV) viral load by polymerase chain reaction (PCR).
IV. To assess the rate of overall response in CLL patients using this treatment regimen.
V. To determine time to progression, time to next treatment, and duration of response in CLL
patients using this treatment regimen.
TERTIARY OBJECTIVES:
I. To assess the correlation between the individual prognostic markers (17p-, 11q-, unmutated
VH gene, use of VH3-21, ZAP70+, CD38+) and clinical outcome.
II. To assess response to this combination regimen using an expanded definition of response,
including bone marrow studies with immunohistochemical studies for residual CLL cells and
sensitive flow cytometry for minimal residual disease in patients in complete clinical
remission.
OUTLINE: This is phase I, dose-escalation study of PGG beta-glucan followed by a phase II
study.
Patients receive PGG beta-glucan intravenously (IV) over 2-4 hours on days 1, 5, 10, 17, 24,
and 31; alemtuzumab subcutaneously (SC) on days 3, 4, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26,
29, 31, and 33; and rituximab IV on days 10, 17, 24, and 31. Treatment continues in the
absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up monthly for 3 months, every 3
months for 1 year, and then every 6 months for 5 years.
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