Study of Talabostat and Rituximab in Advanced Chronic Lymphocytic Leukemia (CLL)
NCT ID: NCT00086203
Last Updated: 2015-03-25
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
PHASE2
INTERVENTIONAL
2007-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Talabostat mesylate (PT-100) tablets
Rituximab
Eligibility Criteria
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Inclusion Criteria
* Histopathologically confirmed diagnosis of B-CLL expressing surface CD20 of any detectable intensity
* Rai Stage III or IV. Rai Stages I and II with massive or progressive lymphadenopathy or hepatosplenomegaly.
* Primary resistance to a fludarabine regimen (no PR or CR) or progressive disease within 1 year of a prior response
* ECOG performance status 0, 1, or 2
* Written informed consent
Exclusion Criteria
* Known primary or secondary malignancy of the central nervous system
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* Serum creatinine \>2.0mg/dL (\>176 micromol/L)
* AST or ALT ≥3 x the upper limit of normal (ULN)
* Total bilirubin ≥1.5 x ULN (unless secondary to Gilbert's)
* Positive serology for hepatitis B (HBsAg) or hepatitis C (anti-HCV antibody)
* Known positivity for HIV
* Prior organ allograft
* Concurrent comorbid medical conditions that, in the opinion of the investigator, preclude the safe delivery of the experimental treatment
* Pregnant or nursing women
18 Years
ALL
No
Sponsors
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Point Therapeutics
INDUSTRY
Locations
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University of Arkansas for Medical Science
Little Rock, Arkansas, United States
Ocala Oncology Center
Ocala, Florida, United States
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States
Indiana Oncology/Hematology Consultants
Indianapolis, Indiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Hematology/Oncology Centers of the Northern Rockies
Billings, Montana, United States
Nevada Cancer Institute
Las Vegas, Nevada, United States
Queens Medical Associates, PC
Fresh Meadows, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
NYU Medical Center
New York, New York, United States
James P. Wilmot Cancer Center/University of Rochester
Rochester, New York, United States
Raleigh Hematology/Oncology Clinic
Cary, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cancer Care Associates/Oklahoma City
Oklahoma City, Oklahoma, United States
Cancer Care Associates--Tulsa
Tulsa, Oklahoma, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, United States
Texas Cancer Center/Abilene
Abilene, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
Virginia Oncology Associates-Lake Wright Cancer Center
Norfolk, Virginia, United States
Countries
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Other Identifiers
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FD-R-003021-01
Identifier Type: -
Identifier Source: secondary_id
PTH-203
Identifier Type: -
Identifier Source: org_study_id
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