CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
alemtuzumab +9 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01269385
NCT01269385Phase 2Completed

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

Mayo Clinic·interventional·Posted Jan 4, 2011·Updated Jun 23, 2020

In Brief

A Phase 2 clinical trial evaluating alemtuzumab, rituximab, and 8 other interventions for B-cell Chronic Lymphocytic Leukemia and 4 related conditions. Completed, enrolled 22 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 4, 2011
Enrollment StartJan 1, 2011
Primary CompletionJun 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 15.5 years ago

Interventions

alemtuzumabbiological

Given subcutaneously

rituximabbiological

Given IV

PGG beta-glucandrug

Given IV

flow cytometryother

Correlative studies

laboratory biomarker analysisother

Correlative studies

DNA analysisgenetic

Correlative studies

fluorescence in situ hybridizationgenetic

Correlative studies

polymerase chain reactiongenetic

Correlative studies

polymorphism analysisgenetic

Correlative studies

mutation analysisgenetic

Correlative studies