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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00036257

Enrollment

Registered

2002-05-09

Start date

2002-03-31

Completion date

2003-04-30

Last updated

2011-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia, Leukemia, CLL

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.

Interventions

DRUGCP-461

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026