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

Chronic Lymphocytic Leukemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00036257
• Other study ID #: OSI-461-010
• Status: Completed
• Phase: Phase 1
• First received: May 8, 2002
• Last updated: October 14, 2011
• Start date: March 2002
• Est. completion date: April 2003

Study information

• Verified date: October 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• CP-461

Locations

Country	Name	City	State
United States	Albany Regional Cancer Center	Albany	New York
United States	Mary Crowley Medical Research Center (US Oncology)	Dallas	Texas
United States	Cancer Centers of Florida	Orlando	Florida
United States	Cancer Care Northwest	Spokane	Washington
United States	Tyler Cancer Center	Tyler	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Cell Pathways, OSI Pharmaceuticals

Country where clinical trial is conducted

United States,