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

Astellas

Status and phase: Completed; Phase 1

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: CP-461

Study type: Interventional

Funder types: Industry

Identifiers

NCT00036257

OSI-461-010

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.