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


Phase 2
18 Years
N/A
Not Enrolling
Both
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
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.

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

OSI-461-005

NCT ID:

NCT00073489

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

Name

Location

Southwest Regional Cancer CenterAustin, Texas  78705
Ocala Oncology CenterOcala, Florida  34474
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Rocky Mountain Cancer CentersThornton, Colorado  80260
Florida Oncology AssociatesOrange Park, Florida  32073
Tyler Cancer CenterTyler, Texas  75702
Cancer Care NorthwestSpokane, Washington  99202
Willamette Valley Cancer CenterEugene, Oregon  97401-8122
Dayton Oncology/Hematology ConsultantsDayton, Ohio  45439
Hematology Oncology Associates of South TexasSan Antonio, Texas  78229
Arizona Hematology & Oncology AssociatesPhoenix, Arizona  85012
Iowa Oncology AssociatesCedar Rapids, Iowa  52403
Oncology/Hematology Associates of Kansas CityKansas City, Missouri  64111
Piedmont Hem Onc Assoc, P.A.Winston-Salem, North Carolina  27103
Oncology & Hematology Associates of Southwest VirginiaRoanoke, Virginia  24101