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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Drug Course 1: plerixafor (20mg/mL). Dose escalation starting with 80 mcg/kg then 160, 240, 320, 420, and 540 mcg/kg, or to de-escalate to 40mcg/kg. Dosing 3 times/week for 3 weeks beginning at start of second week. Rituximab is also administered 3 times per week for 4 weeks using a fixed dose of 100 mg on Day 1 and a dose of 375 mg/m2 for all subsequent doses. Drug Course 2: plerixafor (20 mg/m) same dose as course 1. Dosing 3 times/week for 4 weeks. Rituximab is also administered 3 times per week for 4 weeks using a dose of 375 mg/m2 for all doses.
UCSD Moores Cancer Center
La Jolla, California, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
UTMD Anderson Cancer Center
Houston, Texas, United States
The maximum tolerated dose of plerixafor when combined with rituximab as treatment for previously treated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Time frame: 29 Days
The principal toxicities and dose limiting toxicities of plerixafor when combined with rituximab
Time frame: 73 days
Time to maximal plasma concentration (Tmax) when plerixafor is combined with rituximab
Time frame: Course 1 (4 weeks)
Area under the concentration-time curve from time zero to the last observed concentration (AUC 0-last) when plerixafor is combined with rituximab
Time frame: Course 1 (4 weeks)]
Area under the concentration-time curve over the dosing interval (τ) (AUC 0-τ) when plerixafor is combined with rituximab
Time frame: Course 1 (4 weeks)
Area under the concentration-time curve from time zero to infinity (AUC 0-∞ ) when plerixafor is combined with rituximab
Time frame: Course 1 (4 weeks)
Half-life (T½) when plerixafor is combined with rituximab
Time frame: Course 1 (4 weeks)
Volume of distribution (Vz/F for subcutaneous (SC) administration; Vz for intravenous (IV) administration);
in the case of multiexponential disposition, volume of distribution at steady-state (Vss) will be calculated when plerixafor is combined with rituximab
Time frame: Course 1 (4 weeks)
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