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Home > "A" Clinical Trials Conditions > A Pilot Study of OSI-461 in Patients with Chronic Lymphocytic Leukemia (CLL)  A Pilot Study of OSI-461 in Patients with Chronic Lymphocytic Leukemia (CLL)
A Pilot Study of OSI-461 in Patients with Chronic Lymphocytic Leukemia (CLL)
For Condition: Chronic Lymphocytic Leukemia
Status: No longer recruiting
Sponsor(s): OSI Pharmaceuticals ,
Synopsis: The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.
Details: The primary objective of this study is to determine the activity of OSI-461 given twice daily orally in previously untreated CLL patients. The secondary objective is to evaluate the safety profile of OSI-461 in this patient population.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Diagnosis of CLL established by bone marrow aspiration and biopsy or flow cytometry of peripheral blood. - No previous therapy for CLL. - Expected remaining life span greater than or equal to six months. - 18 years or older. - Willingness and ability to sign an informed consent. Exclusion Criteria: - Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years. - History of other malignancy which could affect the diagnosis or assessment of OSI-461. - Previous therapy for CLL. - Use of an investigational medication or device within one month of initiating study therapy. - Concurrent immunotherapy. - Use of steroids at the time of enrollment (patients who require steroids after enrollment may remain on study). - Any condition or any medication which may interfere with the conduct of the study. - Serious uncontrolled intercurrent medical or psychiatric illness, including serious infection. - Evidence of CNS involvement. - Pregnant or nursing women.
Total Enrollment: 23
Location and Contact Information:
Hematology Oncology Associates of South Texas
San Antonio, Texas, 78229
United States
Rocky Mountain Cancer Centers
Aurora, Colorado, 80012
United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401
United States
Oncology & Hematology Associates of Southwest Virginia
Roanoke, Virginia, 24101
United States
Tyler Cancer Center
Tyler, Texas, 75702
United States
Arizona Hematology & Oncology Associates
Phoenix, Arizona, 85012
United States
Florida Oncology Associates
Jacksonville, Florida, 32207
United States
Piedmont Hem Onc Assoc, P.A.
Winston Salem, North Carolina, 27103
United States
Southwest Regional Cancer Center
Austin, Texas, 78705
United States
Dayton Oncology/Hematology Consultants
Dayton, Ohio, 45439
United States
Ocala Oncology Center
Ocala, Florida, 34474
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615
United States
Cancer Care Northwest
Spokane, Washington, 99202
United States
Iowa Oncology Associates
Cedar Rapids, Iowa, 52403
United States
Oncology/Hematology Associates of Kansas City
Kansas City, Missouri, 64111
United States
Additional Information:
Study ID Numbers: OSI-461-005;
Study Start Date: May 2001
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073489
Other Chronic Lymphocytic Leukemia Studies:
1. A Pilot Study of OSI-461 in Patients with Chronic Lymphocytic Leukemia (CLL)
2. Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Chronic Lymphocytic Leukemia or Other B-cell Cancers
3. Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer
4. Fludarabine and Cyclophosphamide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Leukemia or Lymphoma
5. Autologous T Cell Immunotherapy for Chronic Lymphocytic Leukemia (CLL) Patients
Related Studies:
Other Chronic Lymphocytic Leukemia Clinical Trials
Other Texas Clinical Trials
Other Tyler Clinical Trials
A Pilot Study of OSI-461 in Patients with Chronic Lymphocytic Leukemia (CLL)
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