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Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia
This study has been completed.
Study NCT00036257   Information provided by OSI Pharmaceuticals
First Received: May 8, 2002   Last Updated: April 3, 2009   History of Changes

May 8, 2002
April 3, 2009
March 2002
 
 
 
Complete list of historical versions of study NCT00036257 on ClinicalTrials.gov Archive Site
 
 
 
Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia
 

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.

 
Phase I
Interventional
Treatment, Non-Randomized, Open Label, Safety/Efficacy Study
Chronic Lymphocytic Leukemia
Drug: CP-461
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
15
April 2003
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00036257
 
OSI-461-010
OSI Pharmaceuticals
Cell Pathways
 
OSI Pharmaceuticals
June 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP