Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and maximum tolerated dose of GRN163L in treating patients with refractory or relapsed chronic lymphoproliferative disease.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geron Corporation
• Treatments: Niacinamide

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