Clinical Trials Directory

Trials / Completed

CompletedNCT01269385

Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia

Early Treatment of High Risk Chronic Lymphocytic Leukemia With Alemtuzumab, Rituximab, and PGG Beta-Glucan: A Phase I/II Trial

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Mayo Clinic · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALalemtuzumabGiven subcutaneously
BIOLOGICALrituximabGiven IV
DRUGPGG beta-glucanGiven IV
OTHERflow cytometryCorrelative studies
OTHERlaboratory biomarker analysisCorrelative studies
GENETICDNA analysisCorrelative studies
GENETICfluorescence in situ hybridizationCorrelative studies
GENETICpolymerase chain reactionCorrelative studies
GENETICpolymorphism analysisCorrelative studies
GENETICmutation analysisCorrelative studies

Timeline

Start date
2011-01-01
Primary completion
2014-06-01
Completion
2015-06-01
First posted
2011-01-04
Last updated
2020-06-23
Results posted
2020-06-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01269385. Inclusion in this directory is not an endorsement.