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

Leukemia, Lymphocytic, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055146
• Other study ID #: L4389-34
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2003
• Last updated: April 16, 2009
• Start date: March 2003
• Est. completion date: May 2006

Study information

• Verified date: April 2009
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ONTAK

Locations

Country	Name	City	State
Argentina	Montecaseros	Mendoza
Australia	Peter MacCallum Cancer Institute	East Melbourne	Victoria
Australia	Oncology Day Unit, Frankston Hospital	Frankston
Brazil	Hospital de Cancer de Barretos - Fundacao Pio XII	Barretos	SP
Brazil	Hospital de Clinicas da Universidade Federal do Parana	Curitiba	PR
Brazil	Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias	Goiania	GO
Brazil	Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho	Rio de Janeiro	RJ
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo	SP
Canada	Sir Mortimer B. Davis - Jewish General Hospital	Montreal	Quebec
United States	Rush-Presbyterian St. Luke's Cancer Center	Chicago	Illinois
United States	Pacific Coast Hematology/Oncology Medical Group, Inc.	Fountain Valley	California
United States	University of Texas, M.D. Anderson Cancer Center	Houston	Texas
United States	UCSD School of Medicine	La Jolla	California
United States	Weill Medical College of Cornell University/New York Presbyterian Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Clinical Response
Secondary	Time-to-Progression
Secondary	Duration of response