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A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphocytic, Chronic

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Trial Information

A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Clinical Response

Principal Investigator

Elyane Lombardy, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ligand Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

L4389-34

NCT ID:

NCT00055146

Start Date:

March 2003

Completion Date:

May 2006

Related Keywords:

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

Name

Location

Weill Medical College of Cornell University/New York Presbyterian HospitalNew York, New York  10021
Pacific Coast Hematology/Oncology Medical Group, Inc.Fountain Valley, California  92708
University of Texas, M.D. Anderson Cancer CenterHouston, Texas  77030
UCSD School of MedicineLa Jolla, California  92093-0663
Rush-Presbyterian St. Luke's Cancer CenterChicago, Illinois  60612