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Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036257
Recruitment Status : Completed
First Posted : May 9, 2002
Last Update Posted : October 17, 2011
Cell Pathways
OSI Pharmaceuticals
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
The purposes of this study are to determine a maximum tolerated dose and to evaluate the safety and efficacy of CP-461 in patients with Chronic Lymphocytic Leukemia.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: CP-461 Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 15 participants
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2002
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Relapsed or refractory chronic lymphocytic leukemia.
  2. Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
  3. Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
  4. No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
  5. Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
  6. Expected remaining life span > or = three months.
  7. ECOG performance status 0 - 2.
  8. 18 years or of legal age.
  9. Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.
  10. Negative serum pregnancy test, if fertile female.
  11. Willingness and ability to sign an informed consent document.

Exclusion Criteria:

  1. Evidence of CNS involvement.
  2. Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
  3. Previous therapy with Campath.
  4. Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
  5. Concurrent immunotherapy.
  6. Concurrent use of steroids.
  7. Use of an investigational medication or device within 1 month of initiating study therapy.
  8. Patients who have had allogeneic bone marrow transplantation.
  9. Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.
  10. AST or ALT > 2.5 times the upper limit of normal.
  11. Any condition or any medication which may interfere with the conduct of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036257

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United States, Florida
Cancer Centers of Florida
Orlando, Florida, United States, 32806
United States, New York
Albany Regional Cancer Center
Albany, New York, United States, 12208
United States, Texas
Mary Crowley Medical Research Center (US Oncology)
Dallas, Texas, United States, 75246
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Astellas Pharma Inc
Cell Pathways
OSI Pharmaceuticals

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Responsible Party: Astellas Pharma Inc Identifier: NCT00036257    
Other Study ID Numbers: OSI-461-010
First Posted: May 9, 2002    Key Record Dates
Last Update Posted: October 17, 2011
Last Verified: October 2011
Keywords provided by Astellas Pharma Inc:
Chronic Lymphocytic Leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell