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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-0807 | Other Identifier | Institutional Review Board | |
| A534260 | Other Identifier | UW Madison | |
| SMPH\MEDICINE\HEM-ONC | Other Identifier | UW Madison |
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Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.
Primary objective is to estimate the overall response rate (ORR) and the complete response rate (CRR) to the VcR CVAD regimen (response rate at completion of induction). Patients will receive Rituximab, Bortezomib, cyclophosphamide, Doxorubicin, Vincristine, Dexamethasone in three week intervals for 6 cycles; then rituximab consolidation (weekly x 4) , then one dose of rituximab every 12 weeks until 5 years or disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VCR-CVAD with rituximab maintenance | Experimental | Induction chemotherapy with Bortezomib, cyclophosphamide, rituximab, vincristine, doxorubicin, and dexamethasone. Subjects will receive 6 cycles of induction chemotherapy, of 21 days each. After completing induction, subjects will receive rituximab consolidation (4 weeks), and then rituximab maintenance therapy for up to 5 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Administered by IV at 1.3 mg/m2 days 1 and 4 of each 21 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). | Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy. 1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses. | At completion of induction therapy (21 weeks) |
| Complete Response Rate (CR) at the End of Induction Chemotherapy | Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable. | at 21 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 3 Year Progression Free Survival | This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study. | 36 months |
| 3 Year Overall Survival (OS) |
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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 Cancer Center | Madison | Wisconsin | 53792 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | VCR-CVAD With Rituximab Maintenance |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VCR-CVAD With Rituximab Maintenance |
| 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 | Overall Response Rate (ORR) at the Completion of Induction Chemotherapy, Which is the Percent of Complete Responses (CR) Plus Percent of Partial Responses (PR). | Patients were considered evaluable for response if they completed at least 2 cycles of therapy and had undergone an initial response evaluation, or had disease progression after 1 cycle of therapy. 1999 International Working Group criteria defines a CR as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. Partial Response indicates patients responded to treatment with a reduction in the amount of tumor (50 percent or more). Overall response rate is the percent of complete responses plus the percent of partial responses. | Posted | Nov 2010 | Number | 95% Confidence Interval | Percent of participants | At completion of induction therapy (21 weeks) |
|
Adverse Event collection with 42 months median 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 | VCR-CVAD With Rituximab Maintenance |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Non-systematic Assessment | Grade 3 pain, unrelated to investigational therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia Gr 3 or 4 | Investigations | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brad S Kahl | University of Wisconsin- Madison | 608-263-1836 | bsk@medicine.wisc.edu |
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| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
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| Rituximab | Drug | Administered by IV 375 mg/m2 IV day 1 of each cycle during induction chemotherapy, then weekly for four weeks during consolidation therapy; and then once every 12 weeks for up to 5 years (or until disease progression). |
|
|
| Cyclophosphamide | Drug | Administered by IV at 300 mg/m2, 6 doses spaced 12 hours apart on days 1-3 of each cycle, to start after completion of rituximab infusion |
|
|
| Doxorubicin | Drug | Given as a continuous infusion, 50 mg/m2 over 48 hours days 1-2 of each cycle, to start after completion of rituximab infusion. |
|
| Vincristine | Drug | 1 mg administered by IV on day 3 of each cycle. |
|
| Dexamethasone | Drug | 40 mg orally on days 1-4 of each cycle. |
|
This is the percent of participants who were still alive at 3 years after study entry.
| 36 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Complete Response Rate (CR) at the End of Induction Chemotherapy | Complete Response Rate (CRR) as defined by 1999 International Working Group criteria, is defined as patients with complete disappearance of disease, or regression of all lymph nodes to 1.5 cm in greatest diameter or less. All subjects who had completed 2 cycles of therapy and had at least one disease evaluation, or had completed 1 cycle of therapy with progressive disease, were considered evaluable. | Posted | Nov 2010 | Number | 95% Confidence Interval | percent of participants | at 21 weeks |
|
|
|
| Secondary | 3 Year Progression Free Survival | This is the percent of subjects who had not had any recurrence or relapse of disease as of 3 years after enrollment in the study. | Posted | Nov 2010 | Number | 95% Confidence Interval | percent of participants | 36 months |
|
|
|
| Secondary | 3 Year Overall Survival (OS) | This is the percent of participants who were still alive at 3 years after study entry. | Posted | Nov 2010 | Number | 95% Confidence Interval | Percent of participants | 36 months |
|
|
|
| 18 |
| 30 |
| 30 |
| 30 |
|
| febrile neutropenia | Investigations | CTCAE (3.0) | Non-systematic Assessment | Febrile neutropenia |
|
| Infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Dehydration Gr 3 | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Creatinine Gr 2 | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Mucositis - Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Thrombus | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment | 1 event of picc line clot, one Pulmonary embolus |
|
| myelosuppression | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| progressive disease | General disorders | CTCAE (3.0) | Non-systematic Assessment | admission and death due to progressive lymphoma |
|
| Neutropenia gr 3 or 4 | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hemoglobin gr 3 | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Febrile Neutropenia gr 3 | Injury, poisoning and procedural complications | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection with neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Infection without neutropenia | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hyperglycemia gr 3 | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| hyponatremia gr 3 | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Hypophosphatemia gr 3 | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
| Dehydration gr 3 | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pulmonary Embolism Gr 4 | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Esophagitis Gr 3 | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Mood alteration Gr 3 | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Pain gr 3 | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Sensory neuropathy gr 3 and 4 | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Fatigue gr 3 | General disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| hypogammaglobulinemia | Immune system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Infections secondary to hypogammaglobulinemia in maintenance therapy | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
|
| delayed neutropenia during rituximab maintenance | Investigations | CTCAE (3.0) | Non-systematic Assessment |
|
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013259 | Steroids, Fluorinated |