Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
Chronic Lymphoproliferative Diseases
About this trial
This is an interventional treatment trial for Chronic Lymphoproliferative Diseases focused on measuring Chronic lymphocytic leukemia, T-cell prolymphocytic leukemia, Chronic lymphoproliferative diseases, Telomerase, Telomerase Inhibition
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Male or female Chronic lymphoproliferative disease with related biology or similar clinical pattern to B-Cell Leukemia (CLL)including: small lymphocytic lymphoma (SLL), T cell prolymophocytic leukemia (T-PLL), B cell prolymphocytic leukemia (B-PLL), mantle cell lymphoma or other non-Hodgkins lymphoma in leukemic phase (peripheral blood circulating malignant cells present), Waldenstrom's macroglobulinemia Must have relapsed from or be refractory to prior therapeutic regimens Patients with CLL or SLL must have received at least one prior purine analogue-based chemotherapy regimen (eg, fludarabine, pentostatin or cladribine) If previously treated with an anthracycline, anthracenedione, or trastuzumab, must have left ventricular ejection fraction > 50% ECOG performance status 0-2 Life expectancy 3 months or greater Exclusion Criteria: Pregnant or lactating women Active 2nd malignancy or history of another malignancy within 2 years, except:treated, non-melanoma skin cancer,treated breast or cervical carcinoma in situ,or resected T1a or b prostate cancer Chemotherapeutic agents within 4 weeks prior to study High dose CTX with stem cell support within 6 months prior to study Signal transduction inhibitors,or monoclonal antibodies within 4 weeks prior to study Immunotherapy or biological response modifiers within 4 weeks prior to study Systemic hormonal therapy within 4 weeks prior to study Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study Radiotherapy within 4 weeks prior to study Active autoimmune disorder Central nervous system or leptomeningeal involvement Clinically significant cardiovascular disease Known HIV infection Serious/active infection Surgical procedure within 2 weeks
Sites / Locations
- Rocky Mountain Cancer Center
- Hackensack University Medical Center
- Roswell Park Cancer Center
- Long Island Jewish Medical Center
- Weill Medical College of Cornell University
- The Ohio State University James Cancer Hospital
- UT Southwestern
- University of Texas Health Science Center
Arms of the Study
Arm 1
Other
open label
Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours