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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-00579 | Registry Identifier | NCI Trial ID | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison |
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See 'Limitations and Caveats' section
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression
The objective of this study is to estimate the median progression-free survival for patients receiving this regimen, along with the rate of complete response at 6 months, toxicities associated with this regimen, and laboratory correlates. Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibritumomab Tiuxetan (Zevalin) with Rituximab maintenance | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibritumomab Tiuxetan (Zevalin) + Rituximab | Drug | Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| Median Progression Free Survival (PFS) | Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma). | up to 5 years, 9.5 months, from first day on treatment to last follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 24-month Progression Free Survival (PFS) | Estimate the 24 month progression free survival (PFS), where PFS is defined as the number of days from the first Ibritumomab tiuxetan administration (day 0) to the day the patient experiences an event of disease progression (or death). PFS is summarized as the percentage of patients that survived progression free after 24 months. Progression is defined as any of the following: - Appearances of any new lesions/sites during or after therapy.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brad S Kahl, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Wisconsin | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zevalin With Rituximab Maintenance | Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants with biopsy-proven diagnosis of non-Hodgkin's lymphoma with follicular grade 1, 2, and 3.
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| ID | Title | Description |
|---|---|---|
| BG000 | Zevalin With Rituximab Maintenance | Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Median Progression Free Survival (PFS) | Estimate median progression free survival (PFS), where PFS is defined as the number of days from administration of Ibritumomab tiuxetan In111 (defined as day 1) until the participant develops progressive disease or death from NHL (Non-Hodgkin's Lymphoma). | The study was stopped prematurely, subjects were not followed for a full 7 years. We have data for 16 subjects, 6 experienced a progression event, 10 survived progression-free through last follow-up. Date of last follow-up is used to calculate progression-free survival for those who did not experience progression. | Posted | Median | 80% Confidence Interval | months | up to 5 years, 9.5 months, from first day on treatment to last follow up |
|
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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 | Zevalin With Rituximab Maintenance | Zevalin (Ibritumomab Tiuxetan )+ Rituximab: Subjects will receive the Zevalin(Ibritumomab Tiuxetan) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | CTCAE (2.0) | Systematic Assessment | Infection with grade 3 or 4 neutropenia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Auditory/Ear - Other - Vertigo | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
From IRB: Subjects have completed therapy, ended therapy to progressive disease, or withdrawn. Low enrollment with most not completing planned therapy, it is not powered for meaningful statistical results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lymphoma/Myeloma Disease Oriented Team | University of Wisconsin Carbone Cancer Center | 608-265-3794 | barnstable@wisc.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 |
|---|---|
| C422802 | ibritumomab tiuxetan |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| Up to 24 months |
| Response Rates | To estimate the Complete Response and unconfirmed Complete Response rate (assessing Ibritumomab tiuxetan). Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms, and all dominant lymph nodes and nodal masses have regressed to normal size, and complete resolution of lymphoma in the bone marrow biopsy. Unconfirmed Complete Response (CRu) defined as the above, but with either a > 1.5cm residual node that has decreased by >75%, and/or individual nodes that were previously confluent that have decreased by >75% in SPD, and/or indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). | Up to 5 years and 9.5 months |
| Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0 | To record the toxicities associated with this regimen. | Up to 5 years and 9.5 months |
| Overall Survival (OS) | To estimate overall survival, 95% confidence intervals will be used. | At 12 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 24-month Progression Free Survival (PFS) | Estimate the 24 month progression free survival (PFS), where PFS is defined as the number of days from the first Ibritumomab tiuxetan administration (day 0) to the day the patient experiences an event of disease progression (or death). PFS is summarized as the percentage of patients that survived progression free after 24 months. Progression is defined as any of the following: - Appearances of any new lesions/sites during or after therapy.
| Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Secondary | Response Rates | To estimate the Complete Response and unconfirmed Complete Response rate (assessing Ibritumomab tiuxetan). Complete response is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms, and all dominant lymph nodes and nodal masses have regressed to normal size, and complete resolution of lymphoma in the bone marrow biopsy. Unconfirmed Complete Response (CRu) defined as the above, but with either a > 1.5cm residual node that has decreased by >75%, and/or individual nodes that were previously confluent that have decreased by >75% in SPD, and/or indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). | Posted | Median | 95% Confidence Interval | percentage of participants | Up to 5 years and 9.5 months |
|
|
|
| Secondary | Number of Participants Experiencing Toxicities, Measured by CTCAE v3.0 | To record the toxicities associated with this regimen. | Posted | Count of Participants | Participants | Up to 5 years and 9.5 months |
|
|
|
| Secondary | Overall Survival (OS) | To estimate overall survival, 95% confidence intervals will be used. | Posted | Median | 95% Confidence Interval | percentage of participants | At 12 months |
|
|
|
| 1 |
| 16 |
| 5 |
| 16 |
| 15 |
| 16 |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (2.0) | Systematic Assessment |
|
| Neutrophils/granulocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tranfusion: Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blood/Bone Marrow - Other - Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils/granulo-cytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 109/L | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight gain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatology/Skin - Other - Cold Sore | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatology/Skin - Other - Knee Puncture | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Subject indicated involvement in a deer attack |
|
| Dermatology/Skin - Other - Rash (erythema & scaling) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermatology/Skin - Other - Skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | No other information was provided in the study chart other than "Skin" |
|
| Pruritus/Itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hot Flashes/flushes | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomitting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemmorage/Bleeding - Other - Hemmorage | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Dermatology/Skin - Skin (cellulitus) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Other - Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Pulmonary/Upper Respiratory - Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - Pulmonary/Upper Respiratory - Upper aerodigestive NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | "THRUSH" was documented for all events |
|
| Infection - Pulmonary/Upper Respiratory - Upper Airway NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | "INFECTION - URI [Upper Respiratory Infection]" was documented in all cases |
|
| Infection with normal ANC or Grade 1 or 2 neutropenia - Bronchitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Edema:limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALT, SGOT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | ALT (aspartate aminotranferase increased) documented |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Metabolic/Laboratory - Other - (PT(INR)) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | INR (international normalized ratio) noted on chart |
|
| Metabolic/Laboratory - Other (Sodium - low) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration - anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neurology - Other - Neuralgia | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neurology - Other - Neuro-Sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular/Vision - Other - Vision Problems | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ocular/Vision - Other - Worsening Peripheral Vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Gastrointestinal - Abdomen | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Musculoskeletal - Extremity/Limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Musculoskeletal - Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Gastrointestinal - Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Subject 2 - hip Subject 4 - wrist |
|
| Pain - Neurology - Head/Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Other - Other | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Only "PAIN" documented |
|
| Pain - Other - Splenamalgy | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Pulmonary/Upper Respiratory - Pleura | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Sexual/Reproductive Function - Pelvis | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Musculoskeletal - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Gastrointestinal - Tooth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Hepatobiliary/Pancreas - gallbladder | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Ocular - Eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Other - Groin | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Other - Epigastric | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - Pulmonary/Upper Respiratory - Throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary/Upper Respiratory - Other - Asthma | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal/genitourinary - Other (Dysuria) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Gynecomastia | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
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| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |