Longitudinal Genome-Wide Analysis of Patients with Chronic Lymphocytic Leukemia

Samples from two-center prospective phase 2 clinical trail conducted at Ohio State University (Columbus, OH) and Mayo Clinic (Rochester, MN) were analyzed in 12 cases. All patients had progressive CLL as defined by National Cancer Institute (NCI) Working Group criteria. Patients provided written informed consent for correlative studies according to the Declaration of Helsinki on an institutional review board approved protocol for the collection and use of samples for research purposes from both participating institutions. Eligible patients received a regimen consisting of pentostatin (2 mg/m2), cyclophosphamide (600 mg/m2), and rituximab (375 mg/m2) provided intravenously on day 1 of a 21-day cycle for a maximum of 6 cycles. Responses were assessed by NCI Working Group criteria and included a bone marrow evaluation and two-color flow cytometry 2 months after completion of therapy. Peripheral blood samples from these patients collected longitudinally before (Pre-Baseline), at (Baseline) and after therapy (Relapse) were analyzed for genomic heterogeneity and clonal complexity by high throughput Exome sequencing.]]>
Inclusion of Women: Women were equally eligible to participate as men. CLL is more common in males; therefore, a slightly higher accrual of males was expected. All of the statements discussed under Human Subjects Section applied to the women enrolled on this trial. Inclusion of Minorities: The studies are open to persons of any race or ethnic group, and we expected participation by all ethnic groups. All of the statements discussed under Human Subjects Section applied to the minorities enrolled on this trial. Statistical Considerations for sex/gender and race/ethnicity differences: There was no information currently available regarding differential effects of this regimen in subsets defined by gender, race, or ethnicity, and there was no reason to expect such differences to exist. Exclusion criteria: There was no exclusion criteria set for the study. ]]>