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The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONTAK | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8. | Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression. | From beginning of response to time of relapse |
| Time-to-Treatment Failure |
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Inclusion Criteria:
Pathological diagnosis of low-grade (indolent), B-cell, non-Hodgkin's lymphoma.
Positive expression for CD25 of tumor cells in a lymph node biopsy as defined by greater than 20% of malignant cells staining for CD25 by standardized immunohistochemical assay.
Modified Ann Arbor Stage I, II, III or IV.
Patients must have received at least two but no more than five prior therapies. One prior therapy must have been cytotoxic chemotherapy and one prior therapy must have been monoclonal antibody therapy. Combination chemotherapy, including regimens used prior to bone marrow transplantation, will count as a single therapy for purposes of eligibility.
Patients must have bidimensionally measurable disease.
Patients must be 18 years of age or older.
An ECOG performance status of 0, 1, or 2.
Acceptable organ function defined as follows:
New York Heart Association classification of I or II and no history of poorly controlled hypertension.
Must be free of serious concurrent illness.
Female patients must meet the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elyane Lombardy, M.D. | Ligand Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Baptist Hospital | Lexington | Kentucky | 40503 | United States | ||
| Hematology and Oncology Services |
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This study was recruited at 6 centers in U.S. during the period of 18-May-2000 to 12-May-2001
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| ID | Title | Description |
|---|---|---|
| FG000 | Ontak 4-Course Group | Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days |
| FG001 | Ontak 8-Course Group | Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ontak 4-Course Group | Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days |
| BG001 | Ontak 8-Course Group | Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Clinical Response: Complete Response (CR) or Partial Response (PR) at Week 24, or, in the Event of Lengthened Cycle Intervals, at the End of Cycle 8. | Complete response: achievement of a complete regression for >4 weeks of all palpable and x-ray demonstrable disease and bone marrow disease. Partial response: response to therapy with a 75% reduction in the greatest diameters of the measurable lesions for >4 weeks and had indeterminate bone marrow biopsy | Intent-to-treat | Posted | Number | Participants | 24 Weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ontak 4-Course Group | Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Metabolism and nutrition disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inc | Eisai Call Center | 888-422-4743 |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C078456 | denileukin diftitox |
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| From start of first treatment |
| Metairie |
| Louisiana |
| 70006 |
| United States |
| Withdrawal by Subject |
|
| Death |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
|
|
| Secondary | Duration of Response | The duration of response was defined as the time interval from start of the first response (CR or PR) to the time of documented disease progression. | Intent-to-treat. Please note: Data represent 1 subject in each treatment group who responded. | Posted | Number | Days | From beginning of response to time of relapse |
|
|
|
| Secondary | Time-to-Treatment Failure | Not Posted | From start of first treatment |
| 1 |
| 5 |
| 5 |
| 5 |
| EG001 | Ontak 8-Course Group | Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days | 1 | 4 | 4 | 4 |
| Chest Pain | General disorders |
|
| Progression of Mantle Cell Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders |
|
| Insomnia | Psychiatric disorders |
|
| Headache | Nervous system disorders |
|
| Tachycardia | Cardiac disorders |
|
| Cough | Respiratory, thoracic and mediastinal disorders |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders |
|
| Abdominal Distention | Gastrointestinal disorders |
|
| Abdominal Pain | Gastrointestinal disorders |
|
| Diarrhea | Gastrointestinal disorders |
|
| Lip Blister | Gastrointestinal disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Vomiting | Gastrointestinal disorders |
|
| Rash | Skin and subcutaneous tissue disorders |
|
| Back Pain | Musculoskeletal and connective tissue disorders |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
|
| Asthenia | General disorders |
|
| Chest Discomfort | General disorders |
|
| Fatigue | General disorders |
|
| Oedema Peripheral | General disorders |
|
| Pain | General disorders |
|
| Pyrexia | General disorders |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |