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

December 22, 2015 updated by: Geron Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Rocky Mountain Cancer Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Center
      • New Hyde Park, New York, United States, 11040
        • Long Island Jewish Medical Center
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University James Cancer Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: open label
Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours
Drug: GRN163L
Weekly intravenous infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
First 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PK and PD
Time Frame: Measured in the first 6 weeks
Measured in the first 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geron Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

July 25, 2005

First Submitted That Met QC Criteria

July 25, 2005

First Posted (Estimate)

July 27, 2005

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRN163L CP04-151

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphoproliferative Diseases

Clinical Trials on GRN163L

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe