Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia
Phase 1
Completed
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT00036257
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
- Relapsed or refractory chronic lymphocytic leukemia.
- Patients must have either intermediate or high risk chronic lymphocytic leukemia according to the Rai Staging System.
- Must have failed at least 1 prior chemotherapy regimen (at least 1 of which included fludarabine) for CLL.
- No prior therapy within 4 weeks prior to entering the study. Patients must have fully recovered from the acute effects of prior therapy.
- Platelet count = 75,000/mm3 , hemoglobin = 8 gm/dL.
- Expected remaining life span > or = three months.
- ECOG performance status 0 - 2.
- 18 years or of legal age.
- Male patients or non-pregnant and non-lactating female patients, who are either using adequate birth control, are surgically sterile or post-menopausal.
- Negative serum pregnancy test, if fertile female.
- Willingness and ability to sign an informed consent document.
Exclusion Criteria
- Evidence of CNS involvement.
- Other active malignancy or history of treatment of any malignancy (excluding non-melanoma skin cancer) within the previous three years.
- Previous therapy with Campath.
- Patients with low-risk chronic lymphocytic leukemia according to the Rai Staging System.
- Concurrent immunotherapy.
- Concurrent use of steroids.
- Use of an investigational medication or device within 1 month of initiating study therapy.
- Patients who have had allogeneic bone marrow transplantation.
- Total serum bilirubin above the upper limit of normal; serum creatinine above the upper limit of normal.
- AST or ALT > 2.5 times the upper limit of normal.
- Any condition or any medication which may interfere with the conduct of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Albany Regional Cancer Center
🇺🇸Albany, New York, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Cancer Centers of Florida
🇺🇸Orlando, Florida, United States
Mary Crowley Medical Research Center (US Oncology)
🇺🇸Dallas, Texas, United States