A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL)

Completed · Phase 2

Conditions studied: Chronic Lymphocytic Leukemia

In brief

The objectives of this study are to evaluate the safety and efficacy of OSI-461 in CLL patients.

Key facts

Study ID

NCT00073489

Run by

Astellas Pharma Inc

People needed

23

Starts

2001-05-01

Expected to finish

2003-12-01

Last updated by the study team

2011-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Hematology & Oncology Associates — Phoenix, Arizona, United States
• Rocky Mountain Cancer Centers — Aurora, Colorado, United States
• Florida Oncology Associates — Jacksonville, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Iowa Oncology Associates — Cedar Rapids, Iowa, United States
• Oncology/Hematology Associates of Kansas City — Kansas City, Missouri, United States
• Piedmont Hem Onc Assoc, P.A. — Winston-Salem, North Carolina, United States
• Dayton Oncology/Hematology Consultants — Dayton, Ohio, United States
• Willamette Valley Cancer Center — Eugene, Oregon, United States
• Cancer Centers of the Carolinas — Greenville, South Carolina, United States
• Southwest Regional Cancer Center — Austin, Texas, United States
• Hematology Oncology Associates of South Texas — San Antonio, Texas, United States
• Tyler Cancer Center — Tyler, Texas, United States
• Oncology & Hematology Associates of Southwest Virginia — Roanoke, Virginia, United States
• Cancer Care Northwest — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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