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

Phase 2

Completed

• Conditions: Leukemia, Lymphocytic, Chronic

• Registration Number: NCT00055146
• Lead Sponsor: Eisai Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2003-02-19
• Study First Submitted QC: 2003-02-20
• Study First Posted: 2003-02-21
• Study Start: 2003-03
• Primary Completion: 2006-03
• Study Completion: 2006-05
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-16
• Last Update Posted: 2009-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Objective Clinical Response

Secondary Outcome Measures

Name	Time	Method
Time-to-Progression
Duration of response

Trial Locations

Locations (14)

Montecaseros; 🇦🇷 Mendoza, Argentina

Sir Mortimer B. Davis - Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Peter MacCallum Cancer Institute; 🇦🇺 East Melbourne, Victoria, Australia

Pacific Coast Hematology/Oncology Medical Group, Inc.; 🇺🇸 Fountain Valley, California, United States

Weill Medical College of Cornell University/New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

UCSD School of Medicine; 🇺🇸 La Jolla, California, United States

Rush-Presbyterian St. Luke's Cancer Center; 🇺🇸 Chicago, Illinois, United States

University of Texas, M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Oncology Day Unit, Frankston Hospital; 🇦🇺 Frankston, Australia

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil

Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias; 🇧🇷 Goiania, GO, Brazil

Hospital de Clinicas da Universidade Federal do Parana; 🇧🇷 Curitiba, PR, Brazil

Hospital de Cancer de Barretos - Fundacao Pio XII; 🇧🇷 Barretos, SP, Brazil

Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho; 🇧🇷 Rio de Janeiro, RJ, Brazil