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

• Sponsor: Eisai Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00055146
• Collaborator: (none)
• Enrollment: 41
• Locations: 14
• Duration (Months): 38
• Patients Per Site: 2.9
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic, Chronic	Drug: ONTAK	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
• Study Start Date: Mar 1, 2003
• Actual Primary Completion Date: Mar 1, 2006
• Actual Study Completion Date: May 1, 2006

Outcome Measures

Primary Outcome Measures

1. Objective Clinical Response []

Secondary Outcome Measures

1. Time-to-Progression []

2. Duration of response []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pacific Coast Hematology/Oncology Medical Group, Inc.	Fountain Valley	California	United States	92708
2	UCSD School of Medicine	La Jolla	California	United States	92093-0663
3	Rush-Presbyterian St. Luke's Cancer Center	Chicago	Illinois	United States	60612
4	Weill Medical College of Cornell University/New York Presbyterian Hospital	New York	New York	United States	10021
5	University of Texas, M.D. Anderson Cancer Center	Houston	Texas	United States	77030
6	Montecaseros	Mendoza		Argentina	5500
7	Peter MacCallum Cancer Institute	East Melbourne	Victoria	Australia	3002
8	Oncology Day Unit, Frankston Hospital	Frankston		Australia	3199
9	Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias	Goiania	GO	Brazil	74605-070
10	Hospital de Clinicas da Universidade Federal do Parana	Curitiba	PR	Brazil	80060-900
11	Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho	Rio de Janeiro	RJ	Brazil	21941-590
12	Hospital de Cancer de Barretos - Fundacao Pio XII	Barretos	SP	Brazil	14784-400
13	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo	SP	Brazil	05403-000
14	Sir Mortimer B. Davis - Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2

Sponsors and Collaborators

• Eisai Inc.

Investigators

• Study Director: Elyane Lombardy, M.D., Ligand Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00055146
• Other Study ID Numbers: L4389-34
• First Posted: Feb 21, 2003
• Last Update Posted: Apr 17, 2009
• Last Verified: Apr 1, 2009

• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Apr 17, 2009