Chronic Lymphoproliferative DiseasesPhase 1NCT00124189
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
A Phase 1 study testing GRN163L in people with Chronic Lymphoproliferative Diseases, run by Geron Corporation at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphoproliferative Diseases
- What is being tested?
- GRN163L
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2005to Mar 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Roswell Park Cancer Center
Buffalo, New York, 14263
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210
UT Southwestern
Dallas, Texas, 75390
Rocky Mountain Cancer Center
Denver, Colorado, 80218
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Weill Medical College of Cornell University
New York, New York, 10021
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
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
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.
Read the 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.
- Conditions
- Chronic Lymphoproliferative Diseases
- Being tested
- GRN163L
- Keywords
- Chronic lymphocytic leukemia, T-cell prolymphocytic leukemia, Chronic lymphoproliferative diseases, Telomerase, Telomerase Inhibition
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRN163LDrug
Weekly intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| open label | Other | Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours Receives: Drug: GRN163L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: First 3 weeks
Secondary outcomes (1)
PK and PD
Measured: Measured in the first 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
- Study startJul 2005
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphoproliferative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Kelsey, MD, Study director, Geron Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124189
- Sponsor's protocol ID
- GRN163L CP04-151
- Status last verified
- Dec 2015
- First submitted
- 25 Jul 2005
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00124189
- Acronym / sponsor ID
- GRN163L CP04-151
- Conditions
- Chronic Lymphoproliferative Diseases
- Keywords
- Chronic lymphocytic leukemia, T-cell prolymphocytic leukemia, Chronic lymphoproliferative diseases, Telomerase, Telomerase Inhibition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Geron CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 27 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Other | Drug: GRN163LSequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRN163LWeekly intravenous infusion | Drug | open label |
Primary outcome
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
1 secondary outcome
PK and PD
Time frame: Measured in the first 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Sponsor company web page.Link provided by the sponsor.
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HPC Offered for PRESERVE Expansion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kelsey, MD study director
Geron Corporation
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GRN163L in people with Chronic Lymphoproliferative Diseases, run by Geron Corporation at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.