Safety and Dose Study of GRN163L to Treat Patients With Chronic Lymphoproliferative Disease(CLD)
NCT ID: NCT00124189
Last Updated: 2015-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2005-07-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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open label
Sequential dose cohort, open label, escalation trial evaluating one infusion duration of 2 hours
GRN163L
Weekly intravenous infusion
Interventions
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GRN163L
Weekly intravenous infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Geron Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Kelsey, MD
Role: STUDY_DIRECTOR
Geron Corporation
Locations
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Rocky Mountain Cancer Center
Denver, Colorado, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Center
Buffalo, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States
UT Southwestern
Dallas, Texas, United States
University of Texas Health Science Center
San Antonio, Texas, United States
Countries
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Related Links
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Sponsor company web page.
Other Identifiers
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GRN163L CP04-151
Identifier Type: -
Identifier Source: org_study_id