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| ID | Type | Description | Link |
|---|---|---|---|
| U10CA032102 | U.S. NIH Grant/Contract | View source | |
| S0601 | Other Identifier | SWOG |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving rituximab together with combination chemotherapy and bortezomib may kill more cancer cells. Giving bortezomib as maintenance therapy may keep the cancer from progressing.
PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and bortezomib followed by bortezomib alone works in treating patients with newly diagnosed mantle cell lymphoma.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
After completion of study treatment, patients are followed periodically for 4 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP + Velcade | Experimental | 6 21-day cycles of standard R-CHOP with 1.3 mg/m^2 Bortezomib given on days 1 and 4 of each cycle. This is followed by 8 3-month cycles of maintenance with 1.3 mg/m^2 Bortezomib on days 1, 4, 8 and 11 of each cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rituximab | Biological | 375 mg/m^2 on day 1 for cycles 1-6. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) | Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause. | 0-2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. |
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DISEASE CHARACTERISTICS:
Histologically confirmed mantle cell lymphoma (MCL) meeting the following criteria:
Stage III-IV or bulky stage II disease
Confirmation of positivity for the following phenotypes by immunohistochemistry or flow cytometry:
Newly diagnosed, previously untreated disease
Bidimensionally measurable disease by conventional techniques
Adequate tumor tissue from original diagnostic specimen available
No clinical evidence of central nervous system (CNS) involvement by lymphoma
Co-registration on protocols SWOG-8947 and SWOG-8819 is strongly encouraged
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Steven H. Bernstein, MD | James P. Wilmot Cancer Center | Study Chair |
| Richard I. Fisher, MD | James P. Wilmot Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alaska Regional Hospital Cancer Center | Anchorage | Alaska | 99508 | United States | ||
| Providence Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction | Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days) |
| FG001 | Bortezomib Maintenance (VM) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Initial Registration |
|
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| bortezomib | Drug | 1.3 mg/m^2 on days 1, 4 of cycles 1-6 and on days 1, 4, 8, 11 of cycles 7-14. |
|
|
| cyclophosphamide | Drug | 750 mg/m^2 on day 1 of cycles 1-6. |
|
| doxorubicin hydrochloride | Drug | 50 mg/m^2 on day 1 of cycles 1-6. |
|
| prednisone | Drug | 100 mg on days 1-5 of cycles 1-6. |
|
| vincristine sulfate | Drug | 1.4 mg/m^2 on day 1 of cycles 1-6. |
|
| At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment |
| 2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) | Measured from date of registration to date of death due to any cause or last contact | 0-2 years |
| Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment. |
| Anchorage |
| Alaska |
| 99508 |
| United States |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson | Arizona | 85724-5024 | United States |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Providence Saint Joseph Medical Center - Burbank | Burbank | California | 91505 | United States |
| North Bay Cancer Center | Fairfield | California | 94533 | United States |
| Poudre Valley Hospital | Fort Collins | Colorado | 80524 | United States |
| Broward General Medical Center Cancer Center | Fort Lauderdale | Florida | 33316 | United States |
| M.D. Anderson Cancer Center at Orlando | Orlando | Florida | 32806 | United States |
| Mountain States Tumor Institute at St. Luke's Regional Medical Center | Boise | Idaho | 83712 | United States |
| Decatur Memorial Hospital Cancer Care Institute | Decatur | Illinois | 62526 | United States |
| St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | 46107 | United States |
| Reid Hospital & Health Care Services | Richmond | Indiana | 47374 | United States |
| Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | 66720 | United States |
| Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | 67801 | United States |
| Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | 67042 | United States |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City | Kansas | 66160-7357 | United States |
| Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | 67068 | United States |
| Southwest Medical Center | Liberal | Kansas | 67901 | United States |
| Cancer Center of Kansas, PA - Newton | Newton | Kansas | 67114 | United States |
| Olathe Cancer Center | Olathe | Kansas | 66061 | United States |
| Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | 67357 | United States |
| Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | 67124 | United States |
| Cancer Center of Kansas, PA - Salina | Salina | Kansas | 67042 | United States |
| Tammy Walker Cancer Center at Salina Regional Health Center | Salina | Kansas | 67401 | United States |
| Cotton-O'Neil Cancer Center | Topeka | Kansas | 66606 | United States |
| St. Francis Comprehensive Cancer Center | Topeka | Kansas | 66606 | United States |
| Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | 67152 | United States |
| Associates in Womens Health, PA - North Review | Wichita | Kansas | 67203 | United States |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | 67208 | United States |
| Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | 67214 | United States |
| CCOP - Wichita | Wichita | Kansas | 67214 | United States |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | 67214 | United States |
| Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | 67156 | United States |
| Boston University Cancer Research Center | Boston | Massachusetts | 02118 | United States |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109-0942 | United States |
| Battle Creek Health System Cancer Care Center | Battle Creek | Michigan | 49017 | United States |
| Mecosta County Medical Center | Big Rapids | Michigan | 49307 | United States |
| Butterworth Hospital at Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| CCOP - Grand Rapids | Grand Rapids | Michigan | 49503 | United States |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids | Michigan | 49503 | United States |
| Metro Health Hospital | Grand Rapids | Michigan | 49506 | United States |
| Holland Community Hospital | Holland | Michigan | 49423 | United States |
| Breslin Cancer Center at Ingham Regional Medical Center | Lansing | Michigan | 48910 | United States |
| Hackley Hospital | Muskegon | Michigan | 49442 | United States |
| Munson Medical Center | Traverse City | Michigan | 49684 | United States |
| University of Mississippi Cancer Clinic | Jackson | Mississippi | 39216 | United States |
| CCOP - Kansas City | Kansas City | Missouri | 64131 | United States |
| CCOP - Cancer Research for the Ozarks | Springfield | Missouri | 65802 | United States |
| St. John's Regional Health Center | Springfield | Missouri | 65804 | United States |
| Hulston Cancer Center at Cox Medical Center South | Springfield | Missouri | 65807 | United States |
| CCOP - Montana Cancer Consortium | Billings | Montana | 59101 | United States |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | 59101 | United States |
| Northern Rockies Radiation Oncology Center | Billings | Montana | 59101 | United States |
| St. Vincent Healthcare Cancer Care Services | Billings | Montana | 59101 | United States |
| Billings Clinic - Downtown | Billings | Montana | 59107-7000 | United States |
| Bozeman Deaconess Cancer Center | Bozeman | Montana | 59715 | United States |
| St. James Healthcare Cancer Care | Butte | Montana | 59701 | United States |
| Big Sky Oncology | Great Falls | Montana | 59405-5309 | United States |
| Great Falls Clinic - Main Facility | Great Falls | Montana | 59405 | United States |
| Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | 59405 | United States |
| Great Falls | Montana | 59405 | United States |
| St. Peter's Hospital | Helena | Montana | 59601 | United States |
| Glacier Oncology, PLLC | Kalispell | Montana | 59901 | United States |
| Kalispell Medical Oncology at KRMC | Kalispell | Montana | 59901 | United States |
| Kalispell Regional Medical Center | Kalispell | Montana | 59901 | United States |
| Community Medical Center | Missoula | Montana | 59801 | United States |
| Guardian Oncology and Center for Wellness | Missoula | Montana | 59804 | United States |
| Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | 59807-7877 | United States |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | 59807 | United States |
| Good Samaritan Cancer Center at Good Samaritan Hospital | Kearney | Nebraska | 68848-1990 | United States |
| Adirondack Cancer Care - Glens Falls | Glens Falls | New York | 12801 | United States |
| Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown | New York | 10940-4199 | United States |
| Interlakes Oncology/Hematology PC | Rochester | New York | 14623 | United States |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | 27534 | United States |
| Pardee Memorial Hospital | Hendersonville | North Carolina | 28791 | United States |
| Rutherford Hospital | Rutherfordton | North Carolina | 28139 | United States |
| Mary Rutan Hospital | Bellefontaine | Ohio | 43311 | United States |
| Adena Regional Medical Center | Chillicothe | Ohio | 45601 | United States |
| Charles M. Barrett Cancer Center at University Hospital | Cincinnati | Ohio | 45267 | United States |
| Riverside Methodist Hospital Cancer Care | Columbus | Ohio | 43214-3998 | United States |
| CCOP - Columbus | Columbus | Ohio | 43215 | United States |
| Grant Medical Center Cancer Care | Columbus | Ohio | 43215 | United States |
| Mount Carmel Health - West Hospital | Columbus | Ohio | 43222 | United States |
| Doctors Hospital at Ohio Health | Columbus | Ohio | 43228 | United States |
| Grandview Hospital | Dayton | Ohio | 45405 | United States |
| Good Samaritan Hospital | Dayton | Ohio | 45406 | United States |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | 45409 | United States |
| Samaritan North Cancer Care Center | Dayton | Ohio | 45415 | United States |
| Veterans Affairs Medical Center - Dayton | Dayton | Ohio | 45428 | United States |
| CCOP - Dayton | Dayton | Ohio | 45429 | United States |
| Grady Memorial Hospital | Delaware | Ohio | 43015 | United States |
| Blanchard Valley Medical Associates | Findlay | Ohio | 45840 | United States |
| Middletown Regional Hospital | Franklin | Ohio | 45005-1066 | United States |
| Charles F. Kettering Memorial Hospital | Kettering | Ohio | 45429 | United States |
| Fairfield Medical Center | Lancaster | Ohio | 43130 | United States |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta | Ohio | 45750 | United States |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark | Ohio | 43055 | United States |
| Mercy Medical Center | Springfield | Ohio | 45504 | United States |
| Community Hospital of Springfield and Clark County | Springfield | Ohio | 45505 | United States |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | 45373-1300 | United States |
| Mount Carmel St. Ann's Cancer Center | Westerville | Ohio | 43081 | United States |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | 45385 | United States |
| Genesis - Good Samaritan Hospital | Zanesville | Ohio | 43701 | United States |
| Legacy Mount Hood Medical Center | Gresham | Oregon | 97030 | United States |
| Providence Milwaukie Hospital | Milwaukie | Oregon | 97222 | United States |
| Legacy Good Samaritan Hospital & Comprehensive Cancer Center | Portland | Oregon | 97210 | United States |
| Providence Cancer Center at Providence Portland Medical Center | Portland | Oregon | 97213-2967 | United States |
| Adventist Medical Center | Portland | Oregon | 97216 | United States |
| CCOP - Columbia River Oncology Program | Portland | Oregon | 97225 | United States |
| Providence St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Legacy Emanuel Hospital and Health Center and Children's Hospital | Portland | Oregon | 97227 | United States |
| Legacy Meridian Park Hospital | Tualatin | Oregon | 97062 | United States |
| AnMed Cancer Center | Anderson | South Carolina | 29621 | United States |
| Hollings Cancer Center at Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| CCOP - Upstate Carolina | Spartanburg | South Carolina | 29303 | United States |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | 29303 | United States |
| Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center | Kingsport | Tennessee | 37662 | United States |
| CCOP - Scott and White Hospital | Temple | Texas | 76508 | United States |
| American Fork Hospital | American Fork | Utah | 84003 | United States |
| Sandra L. Maxwell Cancer Center | Cedar City | Utah | 84720 | United States |
| Logan Regional Hospital | Logan | Utah | 84321 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | 84157 | United States |
| Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| LDS Hospital | Salt Lake City | Utah | 84103 | United States |
| Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | 84106 | United States |
| Dixie Regional Medical Center - East Campus | St. George | Utah | 84770 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Southwest Virginia Regional Cancer Center at Wellmonth Health | Norton | Virginia | 24273 | United States |
| St. Joseph Cancer Center | Bellingham | Washington | 98225 | United States |
| Olympic Hematology and Oncology | Bremerton | Washington | 98310 | United States |
| Columbia Basin Hematology | Kennewick | Washington | 99336 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98104 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Minor and James Medical, PLLC | Seattle | Washington | 98104 | United States |
| Group Health Central Hospital | Seattle | Washington | 98112 | United States |
| Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle | Washington | 98122-4307 | United States |
| Polyclinic First Hill | Seattle | Washington | 98122 | United States |
| University Cancer Center at University of Washington Medical Center | Seattle | Washington | 98195-6043 | United States |
| Cancer Care Northwest - Spokane South | Spokane | Washington | 99202 | United States |
| Southwest Washington Medical Center Cancer Center | Vancouver | Washington | 98668 | United States |
| Wenatchee Valley Medical Center | Wenatchee | Washington | 98801-2028 | United States |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | 82801 | United States |
Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
| Eligible |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Maintenance |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rituximab-CHOP-Bortezomib (R-CHOP-V) | R-CHOP-V will be administered for 6 cycles (one cycle is defined as a single 21-day course of treatment). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Response Rate in Patients Treated With Rituximab-CHOPbortezomib Induction Therapy (R-CHOP-V) Followed by Bortezomib Maintenance Therapy(VM). | Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes. | All eligible patients who started treatment were included in the analysis. | Posted | Number | participants | At the time of restaging (between Cycles 6 and 7), every 6 months during Cycles 7-14, and at the end of protocol treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 2-year Progression-free Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) | Measured from date of registration to date of first observation of relapsed or progressive disease, or death due to any cause. | All eligible patients who started treatment were included in the analysis | Posted | Number | 95% Confidence Interval | percentage of participants | 0-2 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 2-year Overall Survival in Patients Treated With Rituximab-CHOP-bortezomib Induction Therapy (RCHOP-V) Followed by Bortezomib Maintenance Therapy (VM) | Measured from date of registration to date of death due to any cause or last contact | All eligible patients who started treatment were included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of participants | 0-2 years |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug | Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal. | Eligible patients who had received any treatment were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which deemed to be related to protocol treatment are included. | Posted | Number | Participants | Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment. |
|
|
Assessed prior to each cycle (for Cycles 2-6), at restaging (between Cycle 6 and 7), every 3 months ( for Cycle 7-14), and at the end of protocol treatment.
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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 | Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction | Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle= 21 days) | 1 | 65 | 64 | 65 | ||
| EG001 | Bortezomib Maintenance (VM) | Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months) | 0 | 47 | 43 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden death | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Auditory/Ear-Other (Specify) | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vision-blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Watery eye (epiphora, tearing) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (clinical exam) - Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symp) - Oral cav | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema: limb | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fever in absence of neutropenia, ANC lt1.0x10e9/L | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain-Other (Specify) | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic reaction/hypersensitivity | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Lung | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Sinus | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Inf w/normal ANC or Gr 1-2 neutrophils - Up airway | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| AST, SGOT | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Creatinine | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Leukocytes (total WBC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolic/Laboratory-Other (Specify) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight gain | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Muscle weakness, not d/t neuropathy - body/general | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pain - Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Mood alteration - depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Allergic rhinitis | 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 |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hair loss/Alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Sweating (diaphoresis) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Urticaria (hives, welts, wheals) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Flushing | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lymphoma Committee Statistician | SWOG Statistical Center | 206-667-4623 |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D000069286 | Bortezomib |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| 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 |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| 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 |
Not provided
Not provided
| Progression/relapse |
|
| Ineligible |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|---|
|
| Unconfirmed Partial Response |
|
| No Response |
|
| Assessment Inadequate |
|
|
|
| Counts |
|---|
| Participants |
|
|