Status:
COMPLETED
Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
Lead Sponsor:
Geron Corporation
Conditions:
Chronic Lymphoproliferative Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00124189
Start Date
July 1 2005
End Date
March 1 2013
Last Update
December 24 2015
Active Locations (8)
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1
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
3
Roswell Park Cancer Center
Buffalo, New York, United States, 14263
4
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040