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

Primary Purpose

Chronic Lymphoproliferative Diseases

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GRN163L
Sponsored by
Geron Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphoproliferative Diseases focused on measuring Chronic lymphocytic leukemia, T-cell prolymphocytic leukemia, Chronic lymphoproliferative diseases, Telomerase, Telomerase Inhibition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rocky Mountain Cancer Center
  • Hackensack University Medical Center
  • Roswell Park Cancer Center
  • Long Island Jewish Medical Center
  • Weill Medical College of Cornell University
  • The Ohio State University James Cancer Hospital
  • UT Southwestern
  • University of Texas Health Science Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

open label

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

PK and PD

Full Information

First Posted
July 25, 2005
Last Updated
December 22, 2015
Sponsor
Geron Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00124189
Brief Title
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geron Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphoproliferative Diseases
Keywords
Chronic lymphocytic leukemia, T-cell prolymphocytic leukemia, Chronic lymphoproliferative diseases, Telomerase, Telomerase Inhibition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
open label
Arm Type
Other
Arm Description
Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours
Intervention Type
Drug
Intervention Name(s)
GRN163L
Intervention Description
Weekly intravenous infusion
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
PK and PD
Time Frame
Measured in the first 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Kelsey, MD
Organizational Affiliation
Geron Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Roswell Park Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Long Island Jewish Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Weill Medical College of Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Ohio State University James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Texas Health Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.geron.com
Description
Sponsor company web page.

Learn more about this trial

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

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