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Sponsors and Collaborators: |
Point Therapeutics FDA Office of Orphan Products Development |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00086203 |
The objective of this study is to assess the efficacy and safety of talabostat and rituximab in patients with advanced CLL who failed to respond, or have progressed following a prior response, to a fludarabine regimen.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia |
Drug: Talabostat mesylate (PT-100) tablets Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
United States, Arkansas | |
University of Arkansas for Medical Science | |
Little Rock, Arkansas, United States, 72205 | |
United States, Florida | |
Gulfcoast Oncology Associates | |
St. Petersburg, Florida, United States, 33705 | |
Ocala Oncology Center | |
Ocala, Florida, United States, 34474 | |
United States, Indiana | |
Indiana Oncology/Hematology Consultants | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Montana | |
Hematology/Oncology Centers of the Northern Rockies | |
Billings, Montana, United States, 59101 | |
United States, Nevada | |
Nevada Cancer Institute | |
Las Vegas, Nevada, United States, 89135 | |
United States, New York | |
James P. Wilmot Cancer Center/University of Rochester | |
Rochester, New York, United States, 14642 | |
Long Island Jewish Medical Center | |
New Hyde Park, New York, United States, 11040 | |
Queens Medical Associates, PC | |
Fresh Meadows, New York, United States, 11365 | |
NYU Medical Center | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Wake Forest University Health Sciences | |
Winston-Salem, North Carolina, United States, 27157 | |
Raleigh Hematology/Oncology Clinic | |
Cary, North Carolina, United States, 27511 | |
United States, Oklahoma | |
Cancer Care Associates/Oklahoma City | |
Oklahoma City, Oklahoma, United States, 73112 | |
Cancer Care Associates--Tulsa | |
Tulsa, Oklahoma, United States, 74136 | |
United States, South Carolina | |
Cancer Centers of the Carolinas | |
Seneca, South Carolina, United States, 29672 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Texas Cancer Center/Abilene | |
Abilene, Texas, United States, 79606-5208 | |
United States, Virginia | |
Virginia Oncology Associates-Lake Wright Cancer Center | |
Norfolk, Virginia, United States, 23502 |
Study ID Numbers: | PTH-203, FD-R-003021-01 |
Study First Received: | June 28, 2004 |
Last Updated: | August 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00086203 |
Health Authority: | United States: Food and Drug Administration |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Rituximab Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |