Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients
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| ClinicalTrials.gov Identifier: NCT00050999 |
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Recruitment Status :
Completed
First Posted : January 3, 2003
Last Update Posted : March 5, 2008
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Sponsor:
Eisai Inc.
Information provided by:
Eisai Inc.
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Brief Summary:
The purpose of this study is to compare the effectiveness of two dose levels of ONTAK (denileukin diftitox) in treating patients who have recurrent or persistent cutaneous T-cell lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, T-Cell, Cutaneous Mycosis Fungoides Sezary Syndrome | Drug: ONTAK | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Enrollment : | 195 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter Phase III Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy of Two Dose Levels of DAB389IL-2 (9 and 18 Mcg/kg/Day) in Cutaneous T-Cell Lymphoma (CTCL) Patients With Stage Ia-III Disease Who, Following Less Than or Equal to 3 Previous Therapies, Have Recurrent or Persistent Disease That Has Been Biopsy-Documented to Express CD25 |
| Study Start Date : | June 1995 |
| Actual Primary Completion Date : | September 2006 |
| Actual Study Completion Date : | December 2006 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Lymphoma
Primary Outcome Measures :
- Objective Rate of Response (ORR), defined as CR + CCR + PR
Secondary Outcome Measures :
- Time-to-Treatment Failure
- Time-to-Progression
- Duration of Response
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab;
- Patient must have had 1 to 3 prior CTCL 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 regimen is permitted. Topical or systemic steroids are not considered a therapy;
- Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry.
- Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months.
- Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
- No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease.
- No systemic infections;
- Willingness to be randomized to a placebo treatment only arm;
- ECOG performance status 0 or 1;
Exclusion Criteria:
• Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050999
Locations
Show 35 study locations
Sponsors and Collaborators
Eisai Inc.
Investigators
| Study Director: | Elyane Lombardy, M.D. | Ligand Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00050999 |
| Obsolete Identifiers: | NCT00002683 |
| Other Study ID Numbers: |
93-04-11 |
| First Posted: | January 3, 2003 Key Record Dates |
| Last Update Posted: | March 5, 2008 |
| Last Verified: | February 2008 |
Additional relevant MeSH terms:
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Mycoses Lymphoma Lymphoma, T-Cell Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |