Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00055146
First received: February 19, 2003
Last updated: April 16, 2009
Last verified: April 2009

February 19, 2003
April 16, 2009
March 2003
March 2006   (final data collection date for primary outcome measure)
Objective Clinical Response
Not Provided
Complete list of historical versions of study NCT00055146 on ClinicalTrials.gov Archive Site
  • Time-to-Progression
  • Duration of response
Not Provided
Not Provided
Not Provided
 
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia

The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leukemia, Lymphocytic, Chronic
Drug: ONTAK
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
May 2006
March 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with B-cell Chronic Lymphocytic Leukemia, Rai Stage 0-II with indication for treatment by NCI Working Group Criteria or Rai Stage III or IV.
  • Patients must have received at least one prior purine analogue-based chemotherapy regimen.
  • ECOG Performance Status of 0, 1, or 2.
  • Female patients cannot be pregnant and must use birth control during the course of the study and for three weeks after the study ends.

Exclusion Criteria:

  • Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
  • Received any therapy for CLL within 35 days prior to study entry.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil,   Argentina,   Australia,   United States,   Canada
 
NCT00055146
L4389-34
Not Provided
Not Provided
Eisai Inc.
Not Provided
Study Director: Elyane Lombardy, M.D. Ligand Pharmaceuticals
Eisai Inc.
April 2009

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