Lymphoma, T-Cell, CutaneousPhase 4NCT00051012
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
A Phase 4 study testing ONTAK in people with Lymphoma, T-Cell, Cutaneous and Mycosis Fungoides, run by Eisai Inc. at 34 sites in 9 countries.
Trial summary
The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- ONTAK
- How many people
- 86 participants
- Where
- 34 sitesin 9 countries
- Study dates
- Sep 1995to Dec 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
- Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
- CTCL disease Stage Ia - III.
- History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
- Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
- No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
- No systemic infections.
- ECOG performance status of 0 or 1.
Who cannot join
- The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.
Trial locations and contacts
34 sites in 9 countries.
34 sites in 9 countries
Germany7 sites
Universitatsklinikum Charite
Berlin
University of Erlangen
Erlangen, 91052
Universitatsklinikum Essen
Essen, 45122
J.W. Goethe University Frankfurt
Frankfurt, 60590
Universitatskrankenhaus Eppendorf
Hamburg, 20246
Universitatsklinikum Mannheim
Mannheim, 68135
Universitatsklinikum Munster
Münster, D-48149
Poland6 sites
Medical Academy in Gdansk, Dept. of Hematology
Gdansk, 80-952
Regional Oncological Center, Dept. of Chemotherapy
Lodz, 93-509
Klinika Hematoonkologii Akademii Medycznej w Lublinie
Lublin, 20-950
Oddzial Chorob Wewnetrznych i Hematologii
Poznan, 61-833
The Medical University of Warsaw, Central Clinical Hospital
Warsaw, 02-097
Centrum Onkologii-Instytut im. Marii Sklodoskiej-Curie
Warsaw, 02-781
Russia6 sites
Blokhin Russian Cancer Research Center, RAMS
Moscow
Burdenko Main Military Clinical Hospital
Moscow
Central Research Institute of Skin and Venereal Diseases
Moscow
Haematology Research Center RAMS
Moscow
St. Petersburg Pavlov State Medical University
Saint Petersburg
Samara Regional Clinical Hospital
Samara, 443095
Australia5 sites
Peter MacCallum Cancer Institute
Melbourne, Victoria, 3002
Level 4 Department of Haematology Royal North Shore Hospital
Saint Leonard's, New South Wales, 2065
Mater Misericordiae Adult Hospital
South Brisbane, Queensland, 4101
Westmead Hospital, Department of Haematology
Westmead, New South Wales, 2145
Oncology Haematology Radiation Oncology Unit, Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Canada3 sites
Cross Cancer Centre
Edmonton, Alberta
Hamilton Regional Cancer Center
Hamilton, Ontario
Jewish General Hospital
Montreal, Quebec
United Kingdom3 sites
St. John's Institute of Dermatology
London
City Hospital
Nottingham
Southampton General Hospital
Southampton
Austria2 sites
LKH Universitatsklinikum Graz
Graz, A-8036
Allgemeines Krankenhaus der Stadt Wien
Vienna, A-1090
United States1 site
University of Texas, M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25
The purpose of this study is to provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.
- Being tested
- ONTAK
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome
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 Rate of Response (ORR), defined as CR + CCR + PR
Secondary outcomes (3)
Time-to-Treatment Failure
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 posted3 Jan 2003 (estimated)
- Study startSep 1995
- Primary completionOct 2006
- Study completionDec 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
- 86 participants
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
- NCT00051012
- Sponsor's protocol ID
- 93-04-14
- Status last verified
- Feb 2008
- First submitted
- 31 Dec 2002
- Last updated
- 5 Mar 2008
- Results posted
- No
Publications
Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. doi: 10.1016/j.clml.2013.02.020. Epub 2013 Jun 14.
PubMed 23770157
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
- A Multicenter Open-Label Study to Evaluate the Safety and Efficacy of DAB389IL-2 in Cutaneous T-Cell Lymphoma (CTCL) Patients Following Protocol 93-04-10, Protocol 93-04-11, or Protocol 92-04-01 or Who Meet the Requirements for Protocol 93-04-11 Except Have Biopsy-Documented CTCL That Does Not Express CD25
- ClinicalTrials.gov ID
- NCT00051012
- Acronym / sponsor ID
- 93-04-14
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 1995
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 3 Jan 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 provide an opportunity for patients who exhibit progressive disease while receiving placebo on the companion 93-04-11 study to receive ONTAK. It is also designed to determine the effectiveness of ONTAK in Cutaneous T-cell Lymphoma (CTCL) patients whose tumors do not express CD25.
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 (7 listed)
- Patient must have been previously enrolled in Protocol 93-04-11 and randomized to the placebo arm; or the patient met all eligibility criteria for protocol 93-04-11 other than the expression of CD25 on CTCL tumor cells.
- CTCL disease Stage Ia - III.
- History of less than or equal to 3 previous therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic chemotherapy regimen is permitted. Topical or systemic steroids are not considered a therapy.
- Patient must have evaluable or measurable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
- No significant pulmonary or cardiac disease. No active CNS, kidney, or liver disease.
Key exclusion criteria (1 listed)
- The 93-04-14 study is no longer open to subjects previously enrolled in 93-04-10 or 92-04-01.
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 Rate of Response (ORR), defined as CR + CCR + PR
3 secondary outcomes
Time-to-Treatment Failure
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 5 Mar 2008.
- Derived from this study: PubMed 23770157Duvic M, Geskin L, Prince HM. Duration of response in cutaneous T-cell lymphoma patients treated with denileukin diftitox: results from 3 phase III studies. Clin Lymphoma Myeloma Leuk. 2013 Aug;13(4):377-84. doi: 10.1016/j.clml.2013.02.020. Epub 2013 Jun 14.
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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
34 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ONTAK in people with Lymphoma, T-Cell, Cutaneous and Mycosis Fungoides, run by Eisai Inc. at 34 sites in 9 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 7 inclusion and 1 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 34 sites in Germany, Poland, Russia, Australia, Canada and 4 more countries. 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?
Objective Rate of Response (ORR), defined as CR + CCR + PR. 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 NCT00051012, 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.