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| ID | Type | Description | Link |
|---|---|---|---|
| 97437 | Other Identifier | Stanford University Alternate IRB Approval Number | |
| LYMNHL0046 | Other Identifier | OnCore |
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Low Accrual
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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The purpose of the study is to assess the response rate of patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma to Iodine-131 (I-131) tositumomab (Bexxar) therapy plus local palliative radiation therapy (XRT).
Response will be assessed on the basis of the presence or absence of measurable lesion ≥ 1.4 x 1.4 cm (operationally defined as ≥ 2.0 cm2) by radiographic evaluation OR ≥ 1.0 cm in greatest diameter detected by palpation on physical exam
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tositumomab + XRT + KI | Experimental | Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bexxar (tositumomab) | Drug | Tositumomab is a CD20-directed radiotherapeutic (131-iodine) monoclonal antibody indicated for the treatment of patients with CD20-positive, relapsed or refractory, low-grade, follicular, or transformed non-Hodgkin's lymphoma who have progressed during or after rituximab therapy, including patients with rituximab-refractory non-Hodgkin's lymphoma. Tositumomab (standard regimen) will be administered at whole body exposure of 75 cGy. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) Rate | Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR
CR Unconfirmed (CRu) criteria
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is assessed as the sum of the overall rates of
| 12 weeks |
| Time-to-Progression (TTP) |
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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 | Tositumomab + XRT + KI | Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Completed Assessment for CR |
| |||||||||||||
| Completed Assessment for TTP |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tositumomab + XRT + KI | Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI) |
| 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 | Complete Response (CR) Rate | Participants assessed for by the following Complete Response (CR) criteria CR or Functional CR
CR Unconfirmed (CRu) criteria
| Posted | Number | percentage of participants | 12 weeks |
|
12 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 | Tositumomab + XRT + KI | Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | 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 |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C119496 | tositumomab I-131 |
| D011878 | Radiotherapy |
| D011193 | Potassium Iodide |
| C010389 | Lugol's solution |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D007454 | Iodides |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
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|
|
| External beam radiotherapy (XRT) | Procedure | Patient-specific XRT will begin within 24 hours of administration of the therapeutic dose of tositumomab. Subjects will receive local XRT to bulky sites of disease measuring at least 5 cm in at least one dimension. The size and number of fields to be treated will determined by the investigators, but will encompass the patient's most symptomatic/threatening site(s) of disease and not cumulatively include more than 25% of the active bone marrow. Subjects will be treated with the 2 x 2 Gy regimen (2 daily fractions of 2 Gy). Sites of disease previously-irradiated with 30 to 40 Gy will not be treated on this study. |
|
|
| Potassium Iodide (KI) | Drug | Potassium iodide (KI) will be administered as:
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|
|
| 2 years |
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Histology | Participants were staged according to the Ann Arbor Staging Classification System, as below. Stage / Characteristics
| Count of Participants | Participants |
|
Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI) |
|
|
| Secondary | Overall Response Rate (ORR) | ORR is assessed as the sum of the overall rates of
| Posted | Number | percentage of participants | 12 weeks |
|
|
|
| Secondary | Time-to-Progression (TTP) | One subject has not progressed (assessment not possible), and one subject has been lost to follow-up. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| 8 |
| 8 |
| 8 |
| 8 |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Thrombocytoperia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Body Aches | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Leukocytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Fatigue | General disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Burning sensation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Chills | General disorders | CTCAE (4.0) | Non-systematic Assessment | Sweating, shock, shaking |
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| Headaches | Nervous system 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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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Equilibrium abnormal | Ear and labyrinth disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Body aches | General disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Infection, Finger | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Itchiness, hands and feet | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Mouth Sores | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
|
| Neuropathy | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment | In fingers/toes |
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| Skin Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Sore Throat | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Stomach Pain | Gastrointestinal disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Swollem Lymph Nodes | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment | L grion, R collarbone, L neck and back |
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| Tremor | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Chest Pain | Cardiac disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Lung Infection | Infections and infestations | CTCAE (4.0) | Non-systematic Assessment |
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| Indigestion | Metabolism and nutrition disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Back spasms | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain in Hip/Leg | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain at biopsy site (lower back) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| R Armpit Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
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| Pain, side | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Non-systematic Assessment | Ribs hurt |
|
| Headache, Chronic | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Headaches | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Non-systematic Assessment |
|
| Itchiness, nose and mouth | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Non-systematic Assessment |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D017680 |
| Potassium Compounds |
| Progressive disease (PD) |
|
|
| 60 months |
|