drugset / Trial / NCT00694590

Study of AMD3100 (Plerixafor) and Rituximab in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT00694590

Phase 1 Completed 24 enrolled Genzyme, a Sanofi Company
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this research study is to determine if plerixafor can make CLL/SLL (Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma) cells more sensitive to being killed by rituximab, an anti-cancer drug that is commonly used in treating CLL and SLL. In this study, plerixafor will be added to standard treatment with rituximab. Subjects will be monitored to see how well they tolerate the use of these drugs together and how well they work to treat the leukemia. The primary objective is to determine the maximum tolerated dose (MTD) of plerixafor when combined with rituximab as treatment for previously treated patients with CLL or SLL.

Timeline

Start
2008-06
Primary completion
2010-11
Completion
2011-09

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Plerixafor Small molecule 40 ug/kg
Subject Plerixafor Small molecule 80 ug/kg
Subject Plerixafor Small molecule 160 ug/kg
Subject Plerixafor Small molecule 240 ug/kg
Subject Plerixafor Small molecule 320 ug/kg
Subject Plerixafor Small molecule 420 ug/kg
Subject Plerixafor Small molecule 540 ug/kg