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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Geron Corporation

ClinicalTrials.gov Identifier:

NCT00124189

First received: July 25, 2005

Last updated: January 9, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 25, 2005

Last Updated Date

January 9, 2013

Start Date ^ICMJE

July 2005

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Maximum Tolerated Dose
Safety measured during each dose administration
Tolerability of each dose administration
Dose-Limiting Toxities evaluated at each dose administration

Change History

Complete list of historical versions of study NCT00124189 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

PK and PD [ Time Frame: Measured in the first 6 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pharmacokinetic profile of GRN163L measured for 2 cycles
Pharmacodynamic markers of GRN163L activity measured each cycle
Preliminary antineoplastic activity

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Chronic Lymphoproliferative Diseases

Intervention ^ICMJE

Drug: GRN163L

Weekly intravenous infusion

Study Arm (s)

open label

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

Intervention: Drug: GRN163L

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00124189

Other Study ID Numbers ^ICMJE

GRN163L CP04-151

Has Data Monitoring Committee

Responsible Party

Geron Corporation

Study Sponsor ^ICMJE

Geron Corporation

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Stephen Kelsey, MD

Geron Corporation

Information Provided By

Geron Corporation

Verification Date

January 2013

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

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