Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00055146




Registration number
NCT00055146
Ethics application status
Date submitted
19/02/2003
Date registered
21/02/2003
Date last updated
17/04/2009

Titles & IDs
Public title
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
Scientific title
A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
L4389-34
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia, Lymphocytic, Chronic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ONTAK

Treatment: Drugs: ONTAK
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Clinical Response
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Time-to-Progression
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Duration of response
Timepoint [2] 0 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2006
Sample size
Target
41
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [2] 0 0
Oncology Day Unit, Frankston Hospital - Frankston
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Argentina
State/province [5] 0 0
Mendoza
Country [6] 0 0
Brazil
State/province [6] 0 0
GO
Country [7] 0 0
Brazil
State/province [7] 0 0
PR
Country [8] 0 0
Brazil
State/province [8] 0 0
RJ
Country [9] 0 0
Brazil
State/province [9] 0 0
SP
Country [10] 0 0
Canada
State/province [10] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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)
Trial website
https://clinicaltrials.gov/ct2/show/NCT00055146
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Elyane Lombardy, M.D.
Address 0 0
Ligand Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00055146