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

Launched by ASTELLAS PHARMA INC · May 8, 2002

Keywords

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Gender

ALL

Eligibility criteria

• 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.