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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 1
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphoproliferative Diseases

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Outcome Time Frame:

First 3 weeks

Safety Issue:

Yes

Principal Investigator

Stephen Kelsey, MD

Investigator Role:

Study Director

Investigator Affiliation:

Geron Corporation

Authority:

United States: Food and Drug Administration

Study ID:

GRN163L CP04-151

NCT ID:

NCT00124189

Start Date:

July 2005

Completion Date:

March 2013

Related Keywords:

  • Chronic Lymphoproliferative Diseases
  • Chronic lymphocytic leukemia
  • T-cell prolymphocytic leukemia
  • Chronic lymphoproliferative diseases
  • Telomerase
  • Telomerase Inhibition
  • Lymphoproliferative Disorders

Name

Location

Hackensack University Medical CenterHackensack, New Jersey  07601
Weill Medical College of Cornell UniversityNew York, New York  10021
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Rocky Mountain Cancer CenterDenver, Colorado  80218
University of Texas Health Science CenterSan Antonio, Texas  78284
Roswell Park Cancer CenterBuffalo, New York  14263
The Ohio State University James Cancer HospitalColumbus, Ohio  43210
UT SouthwesternDallas, Texas  75390