Lymphoma, T-Cell, CutaneousPhase 4NCT00211198
Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL)
A Phase 4 study testing ONTAK (denileukin difitox, DAB389IL-2) in people with Lymphoma, T-Cell, Cutaneous, run by Eisai Inc. at 9 sites in United States.
Trial summary
The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous
- What is being tested?
- ONTAK (denileukin difitox, DAB389IL-2)
- How many people
- 60 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2001to Jan 2006
- Phase
- Phase 4
- 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
- Persistent or recurrent cutaneous T-cell lymphoma (CTCL) Stage IB-IVA as defined by TNM staging.
- Pathologic proven diagnosis (cytologically confirmed) of CTCL documented in patient history.
- Preserved organ function: Creatinine and/or Liver Function levels <1.5 times institutional upper limits of normal (ULN).
- Adequate liver function as indicated by bilirubin < or equal to 1.5 times ULN, ALT < or equal to 2 times ULN, AST < or equal to 2 times ULN.
- Albumin >3.0 g/dL
- Adequate renal function as indicated by SCr < or equal to 2.5 mg/dl.
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- ECOG performance status between 0-2.
- Women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
- Patients over the age of 18 who are willing and able to provide Informed Consent.
Who cannot join
- Pathology consistent with peripheral T-cell lymphoma.
- Stage IVB (visceral involvement with CTCL, other than lymph node involvement).
- History of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
- Patients who are pregnant or breast feeding.
- Allergy to or have history of allergy to diphtheria toxin or IL-2.
- Previous ONTAK® usage.
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- Unstable cardiovascular disease.
- Patients who have received systemic or topical antineoplastic therapy or investigational medications within past 14 days. Exception: Clear evidence of disease progression requiring immediate intervention and in the absence of ongoing toxicity from prior therapy.
- Ongoing deep vein thrombosis or a diagnosis of deep vein thrombosis less than 3 months prior to protocol enrollment.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New England Medical Center
Boston, Massachusetts
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Ohio State University
Columbus, Ohio, 43210
City of Hope National Medical Center
Duarte, California, 91010
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
The University of Iowa
Iowa City, Iowa, 52242
Vanderbilt University
Nashville, Tennessee, 37232
Yale University School of Medicine
New Haven, Connecticut, 06520
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status
The purpose of this research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.
The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Being tested
- ONTAK (denileukin difitox, DAB389IL-2)
- Keywords
- Cutaneous, T-cell lymphoma, ONTAK, CD25
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Lymphoma, T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONTAK (denileukin difitox, DAB389IL-2)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
Secondary outcomes (6)
Physician's Global Assessment (PGA)
Time to Event Variables - Time to response, remission, treatment failure
Response based on the CD25 status
Response based on patient demographics: stage of disease, age, sex, performance status, total dose
Number of cycles completed
6. Assess safety and tolerability of ONTAK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMay 2001
- Primary completionJan 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-Cell, CutaneousStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center, National Cancer Institute (NCI), Ligand Pharmaceuticals
- Investigators
- Francine Foss, M.D., Study chair, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211198
- Sponsor's protocol ID
- #33
- Status last verified
- Feb 2008
- First submitted
- 13 Sep 2005
- Last updated
- 5 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Francine Foss, Madeleine Duvic, Larisa Geskin, Joseph Anderson, Pierluigi Porcu, Raymond J. Hohl, Maureen Cooper, Jasmine M. Zain, John Zic, Patrica Hibberd, and Mark Acosta Efficacy and Safety of Denileukin Diftitox (Ontak®) in the Treatment of Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2712.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of ONTAK® (Denileukin Diftitox, DAB389IL-2) to Estimate Response in Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status
- ClinicalTrials.gov ID
- NCT00211198
- Acronym / sponsor ID
- #33
- Conditions
- Lymphoma, T-Cell, Cutaneous
- Keywords
- Cutaneous, T-cell lymphoma, ONTAK, CD25
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tufts Medical Center, National Cancer Institute (NCI), Ligand Pharmaceuticals
- Study start
- May 2001
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 21 Sep 2005 (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 research study is to evaluate how effective ONTAK is in the treatment of cutaneous T-cell Lymphoma (CTCL) and determine whether the presence of a type of protein called CD25 on the cancer cells makes a difference in how the body responds to the treatment.
The hypothesis is that there is no difference in response rate for patients whose tumor cells are CD25 positive or negative.
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 (9 listed)
- Persistent or recurrent cutaneous T-cell lymphoma (CTCL) Stage IB-IVA as defined by TNM staging.
- Pathologic proven diagnosis (cytologically confirmed) of CTCL documented in patient history.
- Preserved organ function: Creatinine and/or Liver Function levels <1.5 times institutional upper limits of normal (ULN).
- Adequate liver function as indicated by bilirubin < or equal to 1.5 times ULN, ALT < or equal to 2 times ULN, AST < or equal to 2 times ULN.
- Albumin >3.0 g/dL
Key exclusion criteria (9 listed)
- Pathology consistent with peripheral T-cell lymphoma.
- Stage IVB (visceral involvement with CTCL, other than lymph node involvement).
- History of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C infection.
- Patients who are pregnant or breast feeding.
- Allergy to or have history of allergy to diphtheria toxin or IL-2.
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 (denileukin difitox, DAB389IL-2) | Drug | – |
Primary outcome
To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.
6 secondary outcomes
Physician's Global Assessment (PGA)
Time to Event Variables - Time to response, remission, treatment failure
Response based on the CD25 status
Response based on patient demographics: stage of disease, age, sex, performance status, total dose
Number of cycles completed
6. Assess safety and tolerability of ONTAK
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 5 Mar 2008.
- BackgroundFrancine Foss, Madeleine Duvic, Larisa Geskin, Joseph Anderson, Pierluigi Porcu, Raymond J. Hohl, Maureen Cooper, Jasmine M. Zain, John Zic, Patrica Hibberd, and Mark Acosta Efficacy and Safety of Denileukin Diftitox (Ontak®) in the Treatment of Cutaneous T-Cell Lymphoma (CTCL) According to CD25 Status. Blood (ASH Annual Meeting Abstracts), Nov 2006; 108: 2712.
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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.
Francine Foss, M.D. study chair
Yale University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ONTAK (denileukin difitox, DAB389IL-2) in people with Lymphoma, T-Cell, Cutaneous, run by Eisai Inc. at 9 sites in United States.
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 9 inclusion and 9 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 5 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
To estimate response rates (CR + CCR + PR) according to CD25 status (CD25 positive and negative) after 4 cycles of ONTAK.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00211198, which also lists 1 linked publication.
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 5 Mar 2008.