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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00124189
Recruitment Status : Completed
First Posted : July 27, 2005
Last Update Posted : December 24, 2015
Information provided by (Responsible Party):
Geron Corporation

July 25, 2005
July 27, 2005
December 24, 2015
July 2005
March 2013   (Final data collection date for primary outcome measure)
Safety, tolerability, dose-limiting toxicities (DLT), and maximum tolerated dose (MTD) or recommended phase II dose of GRN163L in patients with relapsed or refractory chronic lymphoproliferative disease [ Time Frame: First 3 weeks ]
  • Safety measured during each dose administration
  • Tolerability of each dose administration
  • Dose-Limiting Toxities evaluated at each dose administration
  • Maximum Tolerated Dose
Complete list of historical versions of study NCT00124189 on Archive Site
PK and PD [ Time Frame: Measured in the first 6 weeks ]
  • Pharmacokinetic profile of GRN163L measured for 2 cycles
  • Pharmacodynamic markers of GRN163L activity measured each cycle
  • Preliminary antineoplastic activity
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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
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.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Lymphoproliferative Diseases
Drug: GRN163L
Weekly intravenous infusion
open label
Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours
Intervention: Drug: GRN163L
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2013
March 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
GRN163L CP04-151
Not Provided
Not Provided
Geron Corporation
Geron Corporation
Not Provided
Study Director: Stephen Kelsey, MD Geron Corporation
Geron Corporation
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP