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A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia

Phase 2
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia

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Trial Information

A Pilot Trial of OSI-461 in Patients With Chronic Lymphocytic Leukemia

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.

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

- Previous therapy for CLL.

- Use of an investigational medication or device within one month of initiating study

- 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

- Evidence of CNS involvement.

- Pregnant or nursing women.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

May 2001

Completion Date:

December 2003

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • chronic leukemia
  • leukemia
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



Southwest Regional Cancer Center Austin, Texas  78705
Ocala Oncology Center Ocala, Florida  34474
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Rocky Mountain Cancer Centers Thornton, Colorado  80260
Florida Oncology Associates Orange Park, Florida  32073
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
Dayton Oncology/Hematology Consultants Dayton, Ohio  45439
Hematology Oncology Associates of South Texas San Antonio, Texas  78229
Arizona Hematology & Oncology Associates Phoenix, Arizona  85012
Iowa Oncology Associates Cedar Rapids, Iowa  52403
Oncology/Hematology Associates of Kansas City Kansas City, Missouri  64111
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Oncology & Hematology Associates of Southwest Virginia Roanoke, Virginia  24101