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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1183-0186 | Registry Identifier | WHO |
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This is a randomized, open-label, multi-center, phase 2 study of RCHOP with or without VELCADE in adult patients with previously untreated non-(Germinal B-Cell-like) GCB Diffuse Large B-cell Lymphoma (DLBCL). The study will determine whether the addition of VELCADE to RCHOP improves progression-free survival (PFS) in patients with non-GCB DLBCL.
The drug tested in this study is called bortezomib (VELCADE®). VELCADE® was tested in people who have Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma. This study looked at the efficacy of RCHOP [rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone] with or without VELCADE®.
The study enrolled 206 patients. Participants were enrolled in one of the two open label treatment groups:
Participants received treatment for up to six, 21-day cycles.
This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 48 months. Participants made multiple visits to the clinic, and were followed for progression free survival and overall survival until patient withdrawal, death, or 2 years after the last participant was enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RCHOP | Active Comparator | RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
|
| Vc-RCHOP | Experimental | Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bortezomib | Drug | Bortezomib IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL) | PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. | Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm |
| Progression-Free Survival Rate | PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years. | 2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact. | Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm |
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Each patient must meet all of the following inclusion criteria to be enrolled in the study:
Inclusion Criteria:
Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Millennium Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tower Cancer Research Foundation | Beverly Hills | California | 90211 | United States | ||
| Fountain Valley Regional Hospital |
Participants with a diagnosis of Non-Germinal Center B-Cell-like Diffuse Large B-Cell Lymphoma were enrolled equally in 1 of 2 treatment groups: RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] or Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] for 6, 21 day cycles.
Participants took part in the study at 69 investigative sites in the United States from 13 October 2009 to 15 August 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | RCHOP | RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Rituximab |
| Drug |
Rituximab IV |
|
| Cyclophosphamide | Drug | Cyclophosphamide IV |
|
| Doxorubicin | Drug | Doxorubicin IV solution |
|
| Vincristine | Drug | Vincristine IV |
|
| Prednisone | Drug | Prednisone tablet |
|
| Overall Response Rate (ORR) |
ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. |
| End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment] |
| Complete Response Rate | Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease. | End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment] |
| Duration of Response | Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir. | Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm |
| Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate | FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point. | End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment] |
| Time to Progression (TTP) | TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. | Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category | Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks) |
| Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher | Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE. | Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment) |
| Fountain Valley |
| California |
| 92708 |
| United States |
| St. Jude Heritage Healthcare | Fullerton | California | 92835 | United States |
| Moores Cancer Center- UCSD | La Jolla | California | 92093 | United States |
| Antelope Valley Cancer Center | Lancaster | California | 93534 | United States |
| Loma Linda University Cancer Center | Loma Linda | California | 92354 | United States |
| University of Southern California | Los Angeles | California | 90033 | United States |
| Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
| TORI- Central Pharmacy | Los Angeles | California | United States |
| TORI- Central Regulatory | Los Angeles | California | United States |
| Oncology Care Medical Associates | Montebello | California | 90640 | United States |
| Bay Area Cancer Research Group | Pleasant Hill | California | 94523 | United States |
| Wilshire Oncology Medical Group | Rancho Cucamonga | California | 91730 | United States |
| Sharp Healthcare | San Diego | California | 32123 | United States |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | United States |
| Rocky Mountain Cancer Center | Denver | Colorado | 80218 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33619 | United States |
| Florida Cancer Specialists & Research Institute | Gainsville | Florida | 32605 | United States |
| Alves/ Domenech Oncology-Hematology Clinic | Hollywood | Florida | 33019 | United States |
| Florida Cancer Institute ATI | New Port Richey | Florida | 34655 | United States |
| MD Anderson Cancer Center of Orlando | Orlando | Florida | 32806 | United States |
| Coastal Oncology, PL | Ormond Beach | Florida | 32174 | United States |
| Winship Cancer Institute at Emory University | Atlanta | Georgia | 30322 | United States |
| Georgia Cancer Specialists | Atlanta | Georgia | 30341 | United States |
| Dublin Hematology and Oncology | Dublin | Georgia | 31021 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Central Indiana Cancer Centers | Fishers | Indiana | 46227 | United States |
| Cancer Care Center Inc. P.C. | New Albany | Indiana | 47150 | United States |
| Iowa Blood and Cancer Care | Cedar Rapids | Iowa | 52401 | United States |
| Iowa Oncology Research Association | Des Moines | Iowa | 50309 | United States |
| Siouxland Hematology and Oncology Associates LLP | Sioux City | Iowa | 51101 | United States |
| Kansas City Cancer Center, LLC | Overland Park | Kansas | 66210 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| St. Agnes Hospital of Baltimore | Baltimore | Maryland | 21229 | United States |
| Holy Cross Hospital | Silver Spring | Maryland | 20910 | United States |
| Lahey Clinic Medical Center | Burlington | Massachusetts | 01805 | United States |
| Berkshie Hematology Oncology | Pittsfield | Massachusetts | 01201 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Mid Michigan Physicians | Lansing | Michigan | 48912 | United States |
| Duluth Clinic | Duluth | Minnesota | 55805 | United States |
| St. Luke's Hospital Cancer Care Center | Duluth | Minnesota | 55805 | United States |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | United States |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64111 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Hematology/Oncology Associates of Northern New Jersey, P.A. | Morristown | New Jersey | 07962 | United States |
| Hematology Oncology Associates of South Jersey | Mount Holly | New Jersey | 08060 | United States |
| St. Luke's- Roosevelt Medical Center | New York | New York | 10019 | United States |
| Cornell | New York | New York | United States |
| Raleigh Hematology Oncology Associates P.C. | Raleigh | North Carolina | 27607 | United States |
| Summa Health System | Akron | Ohio | 44304 | United States |
| Oncology Hematology Care | Cincinnati | Ohio | 45267 | United States |
| Kaiser Group Health | Portland | Oregon | 97227 | United States |
| Hematology and Oncology Associates of NEPA | Dunmore | Pennsylvania | 18512 | United States |
| UPMC Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Guthrie Clinic | Sayre | Pennsylvania | 18840 | United States |
| Berks Hematology Oncology Associates | West Reading | Pennsylvania | 19611 | United States |
| South Carolina Oncology Associates, PA | Columbia | South Carolina | 29201 | United States |
| Chattanooga Oncology and Hematology Associates, PC | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | United States |
| US Oncology- Central Drug | Fort Worth | Texas | 76177 | United States |
| US Oncology- Central Laboratory | Fort Worth | Texas | 76177 | United States |
| Oncology Consultants P.A. | Houston | Texas | 77024 | United States |
| Oncology Consultants | Houston | Texas | 77030 | United States |
| US Oncology- Central Regulatory | The Woodlands | Texas | 77380 | United States |
| Tyler Cancer Center | Tyler | Texas | 75702 | United States |
| Texoma Cancer Center | Wichita Falls | Texas | 76310 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Puget Sound Cancer Centers | Edmonds | Washington | 98026 | United States |
| Northwest Cancer Specialists PC | Vancover | Washington | 98686 | United States |
| FG001 | Vc-RCHOP | Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
| Safety Population: Received Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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|
Intent-to-treat (ITT) Population included all randomized participants who had at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | RCHOP | RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
| BG001 | Vc-RCHOP | Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Number | participants |
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| Gender | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Height | Height data is available for n=99, 99 participants, respectively. | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| Body Surface Area | Body Surface Area (m²) is calculated based on patient's height and weight, and is defined as ([Height(cm) x Weight (kg)]/3600). Body Surface Area data is available for n=99, 99 participants respectively. | Mean | Standard Deviation | m^2 |
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| 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 | Progression-Free Survival (PFS) in Patients With Non-germinal Center B-cell-like (Non-GCB) Diffuse Large B-cell Lymphoma (DLBCL) | PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. | Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype. | Posted | Median | 95% Confidence Interval | months | Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm |
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| Primary | Progression-Free Survival Rate | PFS is defined as the time in months from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause. The date of progression is the earliest date of a computed tomography/positron emission tomography (CT/PET) scan that shows evidence of PD. For a participant that has not progressed and is alive at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), PFS is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. The progression-free survival rate is defined as the Kaplan-Meier (KM) estimate of progression-free survival at 2 years. | Modified Intent-to-treat (mITT) Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype. | Posted | Number | percentage of participants | 2 Years (Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm) |
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| Secondary | Overall Survival | Overall survival is defined as the time from the date of randomization to the date of death from any cause. A participant who is alive at the end of his/her study follow-up is censored at the date of last contact. | MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype. | Posted | Median | 95% Confidence Interval | months | Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm |
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| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants with the best overall response complete response (CR) + partial response (PR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=disappearance of all evidence of disease and PR=regression of measurable disease and no new sites. | Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment] |
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| Secondary | Complete Response Rate | Complete Response Rate is defined as the percentage of participants with the best response of Complete Response (CR). Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease. | Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Cycle 2, End of Treatment (Cycle 6) [Median of 16 weeks on treatment] |
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| Secondary | Duration of Response | Duration of response is defined as the time (in months) from the date of first documentation of confirmed complete response (CR) or partial response (PR) to the date of first documentation of progressive disease (PD), relapse from CR or death related to disease. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), duration of response is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using IWG-revised response criteria for malignant lymphoma. CR=Disappearance of all evidence of disease and PR=Regression of measurable disease and no new sites and PD= any new lesion or increase by > 50% of previously involved sites from nadir. | Participants from the Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment who had a CR or PR | Posted | Median | 95% Confidence Interval | months | Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm |
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| Secondary | Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) Negative Rate | FDG-PET negative rate is defined as the percentage of participants FDG-PET negative at the given time-point. | Response-Evaluable Population included all randomized participants who had at least 1 dose of study drug, who had a central laboratory-confirmed non-GCB subtype with measurable disease at Baseline and at least 1 post-baseline response assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | End of Cycle 2 and End of Treatment (Cycle 6) [Median of 16 weeks on treatment] |
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| Secondary | Time to Progression (TTP) | TTP is defined as the time from the date of randomization to the date of first documentation of progressive disease, relapse from CR, or death related to disease under study if participant did not have any documentation of disease progression prior to death caused by lymphoma or complications thereof. For a participant who has not progressed and is not known to have died due to disease under study at the end of his/her study follow-up or at the time of start of an alternate therapy (whichever is first), TTP is censored at the last overall response assessment that is stable disease or better, and which is prior to the start of the alternate therapy, if any. Disease response was assessed using International Working Group (IWG)-revised response criteria for malignant lymphoma. PD= any new lesion or increase by > 50% of previously involved sites from nadir. | MITT Population included all randomized participants who received study drug and who had a central laboratory-confirmed Non-Germinal Center B-Cell (non-GCB) subtype. | Posted | Median | 95% Confidence Interval | months | Median Follow-up of 34.3 months for RCHOP arm and 34.4 months for Vc-RCHOP arm |
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| Secondary | Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) by Category | Percentage of participants in the following categories: • At least 1 TEAE • Drug-related, TEAEs • Grade 3 or higher TEAEs. Grade 3 are AEs of Severe Intensity • Grade 3 or higher drug-related, TEAEs • TEAEs resulting in study drug discontinuation • Serious TEAEs An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. | Safety Population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks) |
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| Secondary | Percentage of Participants With Chemistry and Hematology Laboratory Values Grade 3 or Higher | Percentage of participants who shifted from a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 0, 1, or 2 at Baseline to a Grade 3 or higher on study (worst post-baseline grade). Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe or medically significant but not immediately life-threatening, Grade 4=Life-threatening consequences and 5=Death related to AE. | Safety Population included all randomized participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | Days 1, 4 and 10 of each cycle and end of treatment visit (Median of 16 weeks on treatment) |
|
First dose of study drug through 30 days after the last dose of study drug (Up to 26 Weeks)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RCHOP | RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. | 31 | 100 | 100 | 100 | ||
| EG001 | Vc-RCHOP | Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. | 34 | 101 | 100 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.0 | Systematic Assessment | One treatment-emergent death of septic shock occurred during treatment with RCHOP and is considered related to study treatment by the investigator. |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 18.0 | Systematic Assessment | One treatment-emergent death, Cardio-respiratory arrest occurred during treatment with Vc-RCHOP considered related to study treatment by investigator (other SAEs dehydration,febrile neutropenia,intestinal obstruction,acute kidney injury and syncope). |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nuclear magnetic resonance imaging abnormal | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fluid replacement | Surgical and medical procedures | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor's confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| ID | Term |
|---|---|
| C535661 | Acromesomelic dysplasia, Maroteaux type |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| 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 |
| 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 |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
| > 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| Other |
|
| Not Reported |
|
| OG001 | Vc-RCHOP | Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
|
|
|
|
|
|
|
|
| OG001 | Vc-RCHOP | Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
|
|
|
|
| Vc-RCHOP |
Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
|
|
| OG001 | Vc-RCHOP | Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles. |
|
|
|
|