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

Geron

Status and phase

Completed

Phase 1

Conditions

Chronic Lymphoproliferative Diseases

Treatments

Drug: GRN163L

Study type

Interventional

Funder types

Industry

Identifiers

NCT00124189

GRN163L CP04-151

Details and patient eligibility

About

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.

Full description

Imetelstat Sodium (GRN163L) is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects. High telomerase levels and short telomere lengths correlate with other markers of poor prognosis in patients with chronic lymphoproliferative disease.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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