Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia
NCT ID: NCT00036257
Last Updated: 2011-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2002-03-31
2003-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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CP-461
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Cell Pathways
INDUSTRY
OSI Pharmaceuticals
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Locations
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Cancer Centers of Florida
Orlando, Florida, United States
Albany Regional Cancer Center
Albany, New York, United States
Mary Crowley Medical Research Center (US Oncology)
Dallas, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Cancer Care Northwest
Spokane, Washington, United States
Countries
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Other Identifiers
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OSI-461-010
Identifier Type: -
Identifier Source: org_study_id