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

Completed · Phase 1

Conditions studied: Chronic Lymphoproliferative Diseases

In brief

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.

Key facts

Study ID

NCT00124189

Run by

Geron Corporation

People needed

48

Starts

2005-07-01

Expected to finish

2013-03-01

Last updated by the study team

2015-12-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Rocky Mountain Cancer Center — Denver, Colorado, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Center — Buffalo, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• Weill Medical College of Cornell University — New York, New York, United States
• The Ohio State University James Cancer Hospital — Columbus, Ohio, United States
• UT Southwestern — Dallas, Texas, United States
• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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