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| ID | Type | Description | Link |
|---|---|---|---|
| LYMNHL0019 | Other Identifier | OnCore | |
| 30978 | Other Identifier | Stanford SPO |
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| Name | Class |
|---|---|
| Corixa Corporation | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).
There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population.
This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bexxar + Total Body Irradiation (TBI) | Experimental | Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bexxar | Drug | Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells. Bexxar will be administered to provide the following patient-specific radiotherapy:
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate | Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response. | 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression. | 1.5 months; 3 months; 6 months; or Not Progressed |
| Overall Survival (OS) Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan J Knox | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bexxar | Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bexxar | Phase 2 study in patients with relapsed/refractory DLCL who were not candidates for transplantation. Bexxar was dosed as per the FDA approved regimen for other indications. |
| 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 | Clinical Response Rate | Clinical response rate for all participants, reported as the sum of the numbers of patients achieving complete response (CR, complete disappearance of all lesions); functional CR (fCR, minimal residual disease but clear of disease by positron emission tomography (PET)-scan); or partial response (PR, ≥ decrease in size of lesions and negative for active disease by PET-scan). Progressive disease (PD, advancing cancer) or stable disease (not CR, fCR, or PD) not included as Clinical Response. | Posted | Number | participants | 6 years |
|
3 months
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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 | Bexxar + Tylenol + Benadryl + SSKI | Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. Bexxar is patient specific: 75 cGy whole body patients with platelet count of 150,000/mm³ and 65 cGy for patients with platelet count less than 150,000/mm³, IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susan J Knox, MD, Associate Professor of Radiation Oncology | Stanford University Medical Center | 650-725-2720 | sknox@stanford.edu |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C119496 | tositumomab I-131 |
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| D011193 | Potassium Iodide |
| C010389 | Lugol's solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
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| Acetaminophen | Drug | As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain |
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| Diphenhydramine | Drug | As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions |
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| Potassium Iodide (KI) | Drug | Administered to prevent thyroid blockage 130 mg orally 3 times a day, |
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Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years.
| 6 years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | No |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
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| Secondary | Time to Progression (TTP) | Time of disease progression reported as the number of subjects experiencing disease progression at the time point of progression. | 1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome. | Posted | Number | participants | 1.5 months; 3 months; 6 months; or Not Progressed |
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|
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| Secondary | Overall Survival (OS) Rate | Overall survival reported as the percentage of participants (less lost-to-follow-up) surviving at 6 years. | 1 of the 9 study participants was lost-to-follow-up, and did not contribute data to this outcome. | Posted | Number | percentage of participants | 6 years |
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| 9 |
| 9 |
| 9 |
| 9 |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Stricture | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Vomitting | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Thromnocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Stenosis (including anastomotic GI- Blilary tree) | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Anemia-tachycardia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| hypotension | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Leukocytoperia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Back pains | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Blurred visiom | Eye disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Burning Throat after SSKI | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Diarrehea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Dry Skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fatigue secondary to dexamethasone | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Foot Numbness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| High Neutrophil count | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (4.0) | Non-systematic Assessment | (High BP ~155/103) |
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| Joint Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Left side is sore | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Leg Swelling during the day | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Leukocytoperia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Loose Stools | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Loss of balance | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Low Potassium | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Memory Loss | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Mild headaches | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Neck Irritated | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Neutroperia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Numbness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | in legs and arms |
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| Pain | General disorders | CTCAE (4.0) | Non-systematic Assessment | within body |
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| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Renal insufficiency | Investigations | CTCAE (4.0) | Non-systematic Assessment | Increase Creatinine |
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| Swelling | General disorders | CTCAE (4.0) | Non-systematic Assessment | within the body (arms, legs, groin,etc) |
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| Throbbing Intermittent | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | within the groin area |
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| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Upset Stomach | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Skin Cancers | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment | sideburns, arms, all removed |
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| Small cold | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment | (runny nose, tired) |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007454 | Iodides |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D017680 | Potassium Compounds |
| Title | Measurements |
|---|
|
| Not Progressed |
|