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rituximab and modified (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified Hyper-CVAD | Drug | rituximab and modified hyperfractionated cyclophosphamide, vincristine doxorubicin, dexamethasone (hyperCVAD) administered every 28 days for 4-6 cycles followed by rituximab maintenance therapy consisting of four weekly doses every six months for two years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response Rate to Induction Therapy | Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999). | Median follow up of 37 months |
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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 |
|---|---|---|---|---|---|---|
| UWCCC | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16766582 | Result | Kahl BS, Longo WL, Eickhoff JC, Zehnder J, Jones C, Blank J, McFarland T, Bottner W, Rezazedeh H, Werndli J, Bailey HH; Wisconsin Oncology Network. Maintenance rituximab following induction chemoimmunotherapy may prolong progression-free survival in mantle cell lymphoma: a pilot study from the Wisconsin Oncology Network. Ann Oncol. 2006 Sep;17(9):1418-23. doi: 10.1093/annonc/mdl127. Epub 2006 Jun 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab | Single Arm Maintenance rituximab following induction chemoimmunotherapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | SAEs during induction therapy |
| 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 Rate to Induction Therapy | Outcome is the % of subjects who achieved a Complete Response (CR) or Complete Response Unconfirmed (CRu) after induction therapy, following the Cheson et al criteria for standardized response criteria (1999). | All Subjects enrolled were included in the analysis. Response rate is represented as % of total subjects enrolled. | Posted | Number | 90% Confidence Interval | percentage of participants | Median follow up of 37 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 | Group 1 | SAEs during induction therapy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection with febrile neutropenia, Gr 3 | Infections and infestations |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 19 events of gr 3, 41 events of Gr 4 = 59 events out of 104 cycles of therapy adminsitered. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brad S Kahl, MD | University of Wisconsin | 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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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 8 |
| 22 |
| 22 |
| 22 |
| Neutropenic Fever Gr 3 | Blood and lymphatic system disorders |
|
| Atrial fibrillation gr 3, dyspnea | Cardiac disorders |
|
| perionitis, gr 5 | Infections and infestations | bowel infarction resulting in septicemia |
|
| psuedomonas sepsis, gr 5 | Infections and infestations |
|
| Hyponatremia, gr 3 | Metabolism and nutrition disorders |
|
| Chronic Heart Failure, gr 5 | Cardiac disorders | Pt also experienced sinus tachycardia, hypotension. |
|
|
| febrile neutropenia | Blood and lymphatic system disorders | Events are total occurrences out of 104 cycles of therapy adminsitered across subjects |
|
| infection with neutropenia | Infections and infestations | total is # of grade 3 and 4 events in 104 cycles of therapy administered across 22 subjects. |
|
| Thrombocytopenia | Blood and lymphatic system disorders | 22 cases of grade 3, 2 cases of gr 4 thrombocytopenia out of 104 cycles of therapy administered. |
|
| Anemia | Blood and lymphatic system disorders | 11 cases of grade 3, 1 case of gr 4 anemia out of 104 cycles of therapy administered. |
|
| Hyperglycemia | Metabolism and nutrition disorders | 9 cases of gr 3 hyperglycemia out of 104 cycles of therapy administered. |
|
| dehydration | General disorders | 3 cases of gr 3 dehydration out of 104 cycles of therapy administered. |
|
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| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |