This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a phase I study designed to establish the measurable biological activity of CpG 7909 in vivo. Chronic lymphocytic leukemia (CLL) was chosen because it is an indolent lymphoproliferative disorder and the presence of circulating cells will allow serial sampling of the malignant cells during the study. This is a single dose study with biological endpoints, and therefore, the patients must have received prior therapy for CLL. Once their participation in this trial is complete (4 weeks), they may proceed to other therapies. The primary endpoint is upregulation of CD20 on the surface of CLL cells, with multiple other secondary endpoints. An important aim is to compare the biological effects of CpG 7909 given by two different routes of administration - subcutaneous and intravenous. Dose escalation within each cohort of administration will continue until a dose limiting toxicity is reached, or clear biological activity is established.
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