Title

Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and Maximum Tolerated Dose of GRN163L in Patients With Chronic Lymphoproliferative Disease
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    grn163l ...
  • Study Participants

    48
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.
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.
Study Started
Jul 31
2005
Primary Completion
Mar 31
2013
Study Completion
Mar 31
2013
Last Update
Dec 24
2015
Estimate

Drug GRN163L

Weekly intravenous infusion

open label Other

Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours

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
No Results Posted