Leukemia, Lymphocytic, ChronicPhase 2NCT00055146
Study of ONTAK in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)
A Phase 2 study testing ONTAK in people with Leukemia, Lymphocytic, Chronic, run by Eisai Inc. at 14 sites in 5 countries.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphocytic, Chronic
- What is being tested?
- ONTAK
- How many people
- 41 participants
- Where
- 14 sitesin 5 countries
- Study dates
- Mar 2003to May 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
- Received any therapy for CLL within 35 days prior to study entry.
Trial locations and contacts
14 sites in 5 countries.
14 sites in 5 countries
United States5 sites
Rush-Presbyterian St. Luke's Cancer Center
Chicago, Illinois, 60612
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, 92708
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030
UCSD School of Medicine
La Jolla, California, 92093-0663
Weill Medical College of Cornell University/New York Presbyterian Hospital
New York, New York, 10021
Brazil5 sites
Hospital de Cancer de Barretos - Fundacao Pio XII
Barretos, São Paulo, 14784-400
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, Paraná, 80060-900
Hospital Araujo Jorge - Associacao de Combate ao Cancer em Goias
Goiânia, Goiás, 74605-070
Universidade Federal do Rio de Janeiro - Hospital Universitario Clementino Fraga Filho
Rio de Janeiro, Rio de Janeiro, 21941-590
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, 05403-000
Australia2 sites
Peter MacCallum Cancer Institute
East Melbourne, Victoria, 3002
Oncology Day Unit, Frankston Hospital
Frankston, 3199
Canada1 site
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T 1E2
About this study
Official title: A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)
- Conditions
- Leukemia, Lymphocytic, Chronic
- Being tested
- ONTAK
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONTAKDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Clinical Response
Secondary outcomes (2)
Time-to-Progression
Duration of response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2003 (estimated)
- Study startMar 2003
- Primary completionMar 2006
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Lymphocytic, ChronicStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Elyane Lombardy, M.D., Study director, Ligand Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055146
- Sponsor's protocol ID
- L4389-34
- Status last verified
- Apr 2009
- First submitted
- 19 Feb 2003
- Last updated
- 17 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II Study of ONTAK (Denileukin Diftitox) in Patients With Previously-Treated Chronic Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT00055146
- Acronym / sponsor ID
- L4389-34
- Conditions
- Leukemia, Lymphocytic, Chronic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 21 Feb 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of ONTAK in previously treated patients with chronic lymphocytic leukemia (CLL)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Prior treatment with ONTAK (DAB389IL-2) or DAB486IL-2.
- Received any therapy for CLL within 35 days prior to study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONTAK | Drug | – |
Primary outcome
Objective Clinical Response
2 secondary outcomes
Time-to-Progression
Duration of response
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elyane Lombardy, M.D. study director
Ligand Pharmaceuticals
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ONTAK in people with Leukemia, Lymphocytic, Chronic, run by Eisai Inc. at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Brazil, Australia, Argentina, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Clinical Response. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2009.