The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill). The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
375 mg/m2 Day 1 every 28 days for 6 cycles
5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
St Vincent Regional Cancer Center
Green Bay, Wisconsin, United States
Bellin Memorial Hospital
Green Bay, Wisconsin, United States
Mercy Health System Heme/Onc
Janesville, Wisconsin, United States
Gundersen Clinic
La Crosse, Wisconsin, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States
Waukesha Memorial Hospital
Waukesha, Wisconsin, United States
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States
Progression Free Survival
The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Progression-free Survival
Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Objective Response Rate (Complete + Partial Responses)
Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Overall Survival
Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause.
Time frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
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