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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-004054-21 | EudraCT Number |
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To evaluate the efficacy and safety of lenalidomide, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R2-CHOP) chemotherapy versus placebo, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (placebo-R-CHOP) chemotherapy in patients who have previously untreated ABC type DLBCL.
This research study is for patients with newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL) of the activated B-cell (ABC) type who have not yet been treated. DLBCL is a cancer of a type of blood cell called B-lymphocytes. B lymphocytes are part of the body's immune system. There are different types of DLBCL. About a third of newly diagnosed DLBCL cancers are the ABC type. It has been observed that treatment does not work as well for patients with the ABC type compared to patients with other DLBCL types who receive standard treatment. However, at this time both ABC type and other DLBCL type patients receive the same standard treatments.
Patients with DLBCL who are otherwise healthy are usually treated first with the chemotherapy drug combination called R-CHOP. The drugs in this combination are "R" for rituximab, "C" for cyclophosphamide, "H" for doxorubicin which has a chemical name of hydroxydaunomycin, "O" for vincristine which has a trade name of oncovin, and "P" for prednisone. Depending on the local practice where you are treated, R-CHOP may be given for 6 or 8 cycles. A cycle could lasts for 14 or 21 days. The R-CHOP drug combination is approved for the treatment of DLBCL of all types, including ABC type. R-CHOP is standard care.
This study will test the standard R-CHOP21 against R-CHOP21 plus lenalidomide. The purpose is to see whether adding lenalidomide works better and is as safe as R-CHOP by itself. This study is only for patients with ABC type DLBCL who have not yet been treated. Lenalidomide is not approved for use in DLBCL. Its use in this disease is experimental. In this study, the experimental treatment is lenalidomide + R-CHOP21 x 6.
This study will use a gene expression profile (GEP) test to see if a patient has the ABC type. The results of this GEP test affect whether you may be treated on this study. Because the performance of this test has not been proven, it is for investigational use only, and is still under development. This means the GEP test is an experimental test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R2-CHOP | Experimental | Lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) |
|
| R-CHOP | Active Comparator | Placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier Estimate of Progression Free Survival (PFS) | Progression free survival was defined as the time (months) from the date of randomization to the date of disease progression or death (any cause), whichever occurred earlier and was assessed by the Independent Response Adjudication Committee (IRAC). Relapse from complete response (CR) was considered as disease progression throughout the study. Disease progression was determined based on the Revised Response Criteria for Malignant Lymphoma. The PFS analysis was based on the censoring rules using the Food and Drug Administration (FDA) Guidance. Participants who did not experience disease progression and who did not die before the clinical data cutoff date were censored at the date of last adequate response assessment. | From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) | EFS was defined as the time (months) from randomization until occurrence of one of the following events, whichever occurred first: • Disease progression • Initiation of subsequent systemic anti-lymphoma therapy • Death due to any cause The assessment of EFS was conducted by the IRAC using the International Working Group (IWG) criteria for NHL. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as an EFS event (initiation of subsequent systemic anti-lymphoma therapy) if the decision to treat and the location to be treated was determined prior to randomization. Participants who did not experience any of the events defined in the categories above before the clinical data cutoff date were censored at date last known alive. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 177 | Fayetteville | Arkansas | 72703 | United States | ||
| Local Institution - 136 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27089170 | Background | Nowakowski GS, Chiappella A, Witzig TE, Spina M, Gascoyne RD, Zhang L, Flament J, Repici J, Vitolo U. ROBUST: Lenalidomide-R-CHOP versus placebo-R-CHOP in previously untreated ABC-type diffuse large B-cell lymphoma. Future Oncol. 2016 Jul;12(13):1553-63. doi: 10.2217/fon-2016-0130. Epub 2016 Apr 18. | |
| 39563886 | Derived |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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Intent to Treat (ITT) population - all randomized participants. Safety population - all participants that received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide Plus R-CHOP (R2-CHOP) | Participants received lenalidomide 15 mg capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 cycles. Treatment continued until completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, whichever occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Pre-Treatment Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2019 | Feb 18, 2020 |
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| Rituximab | Drug |
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| Cyclophosphamide | Drug |
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| Doxorubicin | Drug |
|
| prednisone | Drug |
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| vincristine | Drug |
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| From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months |
| K-M Estimate of Overall Survival (OS) | Overall survival was assessed by the Independent Response Adjudication Committee (IRAC) and defined as time from randomization until death due to any cause. Participants who withdrew consent were censored at the time of withdrawal. Participants who were still alive before the clinical data cutoff date and participants who were lost to follow-up were censored at date last known alive. | From randomization until death due to any cause (up to approximately 86 months) |
| Percentage of Participants Who Achieved a Complete Response (CR) | The percentage of participants who achieved a CR after initiation of the study treatment and prior to initiation of subsequent systemic antilymphoma therapy as assessed by the IRAC. A CR = complete metabolic response; target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow per International Working Group (IWG) 2014 for Non-Hodgkin's Lymphoma (NHL). Participants who did not have any adequate response assessments during this period were not considered as responders. | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months |
| Percentage of Participants Who Achieved an Objective Response | An objective response = percentage of participants who achieved a complete response or partial response after initiation of the treatment and prior to initiation of subsequent systemic anti-lymphoma therapy. A CR = complete metabolic response; Target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter; no new lesions. Participants who did not have any adequate response assessments during this period were not considered as responders. | From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm |
| K-M Estimate of Duration of Complete Response | Duration of complete response was calculated for complete responders only and was defined as the time from documented initial complete response prior to initiation of subsequent systemic antilymphoma therapy until documented disease progression or death, whichever occurred earlier. Participants who had not progressed or died at the time of the analysis were censored at the date of last response assessment demonstrating no disease progression. Participants who changed treatment without evidence of disease progression were censored at the last assessment showing no progression prior to treatment change. | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months. |
| K-M Estimate of Time to Next Lymphoma Therapy (TTNLT) | Time to next lymphoma therapy was defined as the time from randomization to the time of treatment change for the next lymphoma treatment. Participants without treatment change were censored at date last known alive. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as treatment change for the next lymphoma therapy if the decision to treat and the location to be treated were determined prior to randomization. | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months |
| Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire | The completion rate for FACT-Lym assessments was judged by looking at the number of completed FACT-Lym assessments at each time point. The FACT-Lym was considered completed if at least 1 calculable score was present. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The FACT-Lym is a health related quality of life (HRQoL) questionnaire targeted to the management of chronic illness, predominantly within oncology and is considered an extension of the FACT-General questionnaire. | Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
| Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire | The completion rate for EQ-5D assessments was judged by looking at the number of completed assessments at each time point. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to "no problems", "some problems" and "extreme problems". The instrument is scored using the United Kingdom (UK) index ranges from -0.594 - 1, where 0 equates to death and 1 equates to full health -0.594 is considered 'worse than death'. | Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
| Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The physical well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL. | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
| Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms such as pain, itching, night sweats,trouble sleeping, fatigue and trouble concentrating and concerns regarding lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The Additional Concerns subscale ranges from 0 to 60, where higher scores reflect better HRQoL. | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
| Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The functional well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL. | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
| Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI) | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The FACT-Lym TOI is calculated by summing the Physical Well-being, Functional Well-being and Additional Concerns scores and has a range of 0 to 116. Higher scores reflect better HRQoL or fewer symptoms. | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
| Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score | The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to "no problems", "some problems" and "extreme problems". The instrument is scored as a single summary index using one of the available EQ-5D-3L value sets; in this study the UK scoring weights 9 were used. The UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health (-0.594 is considered 'worse than death'). | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
| Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS) | The EQ-5D-3L questionnaire includes a visual analogue scale which records the respondent's self-rated health on a vertical, 0-100 scale where 100 = "Best imaginable health state" and 0 = "Worst imaginable health state". Higher scores again indicate better HRQoL and positive change scores indicate that post screening values were higher than those observed at screening. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to "no problems", "some problems" and "extreme problems". | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
| Orange |
| California |
| 92868 |
| United States |
| Local Institution - 127 | Sacramento | California | 95817 | United States |
| Local Institution - 169 | New Haven | Connecticut | 06510 | United States |
| Local Institution - 128 | Hollywood | Florida | 33021 | United States |
| McFarland Clinic | Ames | Iowa | 50010-3014 | United States |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | 51101-1733 | United States |
| Local Institution - 143 | Fairway | Kansas | 66205 | United States |
| Local Institution - 158 | Shreveport | Louisiana | 71103 | United States |
| Center For Cancer And Blood Disorders | Bethesda | Maryland | 20817 | United States |
| Local Institution - 101 | Minneapolis | Minnesota | 55416 | United States |
| Local Institution - 138 | Minneapolis | Minnesota | 55455 | United States |
| Local Institution - 112 | Rochester | Minnesota | 55905 | United States |
| Local Institution - 103 | Durham | North Carolina | 27710 | United States |
| Local Institution - 161 | Philadelphia | Pennsylvania | 19111 | United States |
| Local Institution - 951 | Dallas | Texas | 75235 | United States |
| Local Institution - 151 | Dallas | Texas | 75390-9068 | United States |
| Local Institution - 146 | Salt Lake City | Utah | 84106 | United States |
| Local Institution - 905 | Edmonds | Washington | 98026 | United States |
| Local Institution - 903 | Issaquah | Washington | 98029 | United States |
| Local Institution - 162 | Seattle | Washington | 98104 | United States |
| Local Institution - 904 | Seattle | Washington | 98107 | United States |
| Local Institution - 004 | Albury | New South Wales | 2640 | Australia |
| Local Institution - 008 | Clayton | Victoria | 3168 | Australia |
| Local Institution - 002 | Geelong | Victoria | 3220 | Australia |
| Local Institution - 003 | Frankston | 3199 | Australia |
| Local Institution - 301 | Brussels | 1200 | Belgium |
| Local Institution - 307 | Liège | 4000 | Belgium |
| Local Institution - 305 | Roeselare | 8800 | Belgium |
| Local Institution - 303 | Sint-Niklaas | 9100 | Belgium |
| Local Institution - 368 | Calgary | Alberta | T2N 4N2 | Canada |
| Local Institution - 373 | Surrey | British Columbia | V3T 0H1 | Canada |
| Local Institution - 366 | Saint John | New Brunswick | E2L 3L6 | Canada |
| Local Institution - 362 | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Local Institution - 365 | Montreal | Quebec | H1T 2M4 | Canada |
| Local Institution - 209 | Beijing | 100044 | China |
| Local Institution - 206 | Beijing | 100142 | China |
| Local Institution - 215 | Beijing | 100191 | China |
| Local Institution - 200 | Beijing | 100730 | China |
| Local Institution - 211 | Changchun | 130021 | China |
| Local Institution - 210 | Chengdu | 610041 | China |
| Local Institution - 213 | Chongqing | 400037 | China |
| Local Institution - 202 | Fuzhou | 350001 | China |
| Local Institution - 217 | Guangzhou, Guangdong | 510080 | China |
| Local Institution - 204 | Hangzhou | 310003 | China |
| Local Institution - 207 | Harbin, Heilongjiang | 150081 | China |
| Local Institution - 212 | Nanjing | 210029 | China |
| Local Institution - 205 | Nanjing, Jiangsu | 210009 | China |
| Local Institution - 214 | Shanghai | 200032 | China |
| Local Institution - 219 | Suzhu | 215006 | China |
| Local Institution - 221 | Tianjin | 300060 | China |
| Local Institution - 203 | Wuhan | 430030 | China |
| Local Institution - 376 | Brno | 625 00 | Czechia |
| Local Institution - 377 | Hradec Králové | 500 05 | Czechia |
| Local Institution - 379 | Olomouc | 775 20 | Czechia |
| Local Institution - 380 | Prague | 100 34 | Czechia |
| Local Institution - 378 | Prague | 128 08 | Czechia |
| Local Institution - 576 | Bayonne | 64109 | France |
| Local Institution - 585 | Bordeaux | 33076 | France |
| Local Institution - 583 | Montpellier | 34295 | France |
| Local Institution - 582 | Paris | 75010 | France |
| Local Institution - 588 | Pessac | 33604 | France |
| Local Institution - 587 | Toulose | 31059 | France |
| Local Institution - 581 | Vandœuvre-lès-Nancy | 54511 | France |
| Local Institution - 893 | Dublin | 4 | Ireland |
| Local Institution - 894 | Galway | ST46QG | Ireland |
| Local Institution - 273 | Beersheba | 84101 | Israel |
| Local Institution - 274 | Haifa | 31096 | Israel |
| Local Institution - 272 | Jerusalem | 91120 | Israel |
| Local Institution - 275 | Kfar Saba | 44281 | Israel |
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| Local Institution - 278 | Tel Aviv | 64239 | Israel |
| Local Institution - 270 | Ẕerifin | 70300 | Israel |
| Local Institution - 690 | Terni | Umbria | 05100 | Italy |
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| Local Institution - 666 | Milan | 20132 | Italy |
| Local Institution - 653 | Milan | 20133 | Italy |
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| Local Institution - 668 | Reggio Emilia | 42100 | Italy |
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| Local Institution - 689 | Roma | 00128 | Italy |
| Local Institution - 694 | Roma | 00161 | Italy |
| Local Institution - 673 | Roma | 00189 | Italy |
| Local Institution - 656 | Rome | 00152 | Italy |
| Local Institution - 671 | Torino | 01012 | Italy |
| Local Institution - 662 | Torino | 10126 | Italy |
| Local Institution - 681 | Tricase | 73039 | Italy |
| Local Institution - 692 | Udine | 33100 | Italy |
| Local Institution - 682 | Verona | 37134 | Italy |
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| Local Institution - 508 | Chuo-ku | Tokyo | 104-0045 | Japan |
| Local Institution - 509 | Koto-ku | Tokyo | 1358550 | Japan |
| Local Institution - 502 | Minato-ku | Tokyo | 105-8470 | Japan |
| Local Institution - 513 | Akita | 010-8543 | Japan |
| Local Institution - 511 | Fukuoka | 812-8582 | Japan |
| Local Institution - 505 | Isehara City, Kanagawa | 259-1193 | Japan |
| Local Institution - 501 | Kashiwa | 277-8577 | Japan |
| Local Institution - 510 | Kyoto | 602-8566 | Japan |
| Local Institution - 506 | Minami-Ku, Fukuoka | 811-1347 | Japan |
| Local Institution - 507 | Nagoya | 464-8681 | Japan |
| Local Institution - 515 | Sendai | 983-8520 | Japan |
| Local Institution - 504 | Yamagata | 990-9585 | Japan |
| Local Institution - 353 | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Local Institution - 358 | Amsterdam | 1081 HV | Netherlands |
| Local Institution - 359 | Breda | 4818 CK | Netherlands |
| Local Institution - 357 | Hoofddorp | 2135 | Netherlands |
| Local Institution - 354 | Leeuwarden | 8934 AD | Netherlands |
| Local Institution - 350 | Schiedam | 3118 JH | Netherlands |
| Local Institution - 240 | Christchurch | 8011 | New Zealand |
| Local Institution - 243 | Palmerston | 4414 | New Zealand |
| Local Institution - 730 | Figueira da Foz Municipality | 3094-001 | Portugal |
| Local Institution - 732 | Lisbon | 1099-023 | Portugal |
| Local Institution - 729 | Lisbon | 1400-038 | Portugal |
| Local Institution - 727 | Pragal | 2801-951 | Portugal |
| Local Institution - 115 | San Juan | 00918 | Puerto Rico |
| Local Institution - 050 | Kazan' | 420029 | Russia |
| Local Institution - 052 | Moscow | 115478 | Russia |
| Local Institution - 051 | Saint Petersburg | 197758 | Russia |
| Local Institution - 830 | Gyeonggi-do | 410-769 | South Korea |
| Local Institution - 826 | Seoul | 06591 | South Korea |
| Local Institution - 829 | Seoul | 135-710 | South Korea |
| Local Institution - 828 | Seoul | 138-736 | South Korea |
| Local Institution - 776 | Barcelona | 08025 | Spain |
| Local Institution - 780 | Barcelona | 08916 | Spain |
| Local Institution - 796 | Cáceres | 10003 | Spain |
| Local Institution - 783 | Madrid | 28007 | Spain |
| Local Institution - 785 | Madrid | 28034 | Spain |
| Local Institution - 787 | Madrid | 28040 | Spain |
| Local Institution - 788 | Madrid | 28050 | Spain |
| Local Institution - 797 | Salamanca | 37007 | Spain |
| Local Institution - 790 | Seville | 41013 | Spain |
| Local Institution - 800 | Seville | 41014 | Spain |
| Local Institution - 793 | Valencia | 46010 | Spain |
| Local Institution - 802 | Valencia | 46026 | Spain |
| Local Institution - 323 | Bellinzona | 6500 | Switzerland |
| Local Institution - 320 | Geneva | 1211 | Switzerland |
| Local Institution - 321 | Winterthur | 8400 | Switzerland |
| Local Institution - 253 | Niao-Sung Hsiang Kaohsiung County | 83301 | Taiwan |
| Local Institution - 255 | Taichung | 40447 | Taiwan |
| Local Institution - 252 | Taipei, Zhongzheng Dist. | 10002 | Taiwan |
| Local Institution - 429 | Adana | 01330 | Turkey (Türkiye) |
| Local Institution - 431 | Ankara | 06590 | Turkey (Türkiye) |
| Local Institution - 430 | Antalya | 07058 | Turkey (Türkiye) |
| Local Institution - 435 | Denizli | 20070 | Turkey (Türkiye) |
| Local Institution - 428 | Edirne | 22030 | Turkey (Türkiye) |
| Local Institution - 432 | Istanbul | 34093 | Turkey (Türkiye) |
| Alfaifi A, Bahashwan S, Alsaadi M, Ageel AH, Ahmed HH, Fatima K, Malhan H, Qadri I, Almehdar H. Advancements in B-Cell Non-Hodgkin's Lymphoma: From Signaling Pathways to Targeted Therapies. Adv Hematol. 2024 Nov 12;2024:5948170. doi: 10.1155/2024/5948170. eCollection 2024. |
| 33621109 | Derived | Nowakowski GS, Chiappella A, Gascoyne RD, Scott DW, Zhang Q, Jurczak W, Ozcan M, Hong X, Zhu J, Jin J, Belada D, Bergua JM, Piazza F, Mocikova H, Molinari AL, Yoon DH, Cavallo F, Tani M, Yamamoto K, Izutsu K, Kato K, Czuczman M, Hersey S, Kilcoyne A, Russo J, Hudak K, Zhang J, Wade S, Witzig TE, Vitolo U. ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2021 Apr 20;39(12):1317-1328. doi: 10.1200/JCO.20.01366. Epub 2021 Feb 23. |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls | View source |
| FG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
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| COMPLETED | Completed = Received StudyTreatment |
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| NOT COMPLETED |
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| Treatment Period |
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The Intent-to-treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not.
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| ID | Title | Description |
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| BG000 | Lenalidomide Plus R-CHOP (R2-CHOP) | Participants received lenalidomide 15 mg capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 cycles. Treatment continued until completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, whichever occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
| BG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
| BG002 | Total | Total of all reporting groups |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Body Surface Area (BSA) | Body surface area is the calculated surface of a human body. BSA is often considered a more accurate measure of metabolic mass than body weight, since it's less affected by irregular amounts of fat tissue. | Mean | Standard Deviation | m^2 |
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| Eastern Cooperative Oncology Group (ECOG) Performance Status | The ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions; 1 = Restricted activity but ambulatory, able to carry out work of a light nature; 2 = Ambulatory and capable of all self-care but unable to carry out work activities; 3 = Limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled, no self-care, confined to bed or chair; 5 = Dead | Count of Participants | Participants |
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| Creatinine Clearance | Creatinine is a waste product from the normal breakdown of muscle tissue. As creatinine is produced, it's filtered through the kidneys and excreted in urine. Doctors measure the blood creatinine level as a test of kidney function. | One creatinine clearance value is missing. | Mean | Standard Deviation | mL/min |
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| International Prognostic Index (IPI) Score | The IPI score is a clinical tool developed to aid in predicting the prognosis of patients with aggressive non-Hodgkin's lymphoma, including DLBCL. One point is assigned for each of the following risk factors: Age greater than 60 years, Stage III or IV disease, elevated serum lactate dehydrogenase (LDH), ECOG performance status of 2, 3, or 4, more than 1 extranodal site. The sum of the points allotted correlates with the following risk groups: Low risk (0-1 points) Low-intermediate risk (2 points) High-intermediate risk (3 points) High risk (4-5 points) | Count of Participants | Participants |
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| Presence of Bulky Disease | Count of Participants | Participants |
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| Disease Stage of Diffuse Large B-Cell Lymphoma at Diagnosis | The criteria for clinical stage (Ann Arbor staging) are as below: I: involvement of a single nodal region. II: involvement of 2 or more lymph node regions on the same side of the diaphragm. III: involvement of lymph node regions on both sides of the diaphragm. IV: disseminated involvement of 1 or more extra-lymphatic sites with or without associated lymph node involvement. | Count of Participants | Participants |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Kaplan-Meier Estimate of Progression Free Survival (PFS) | Progression free survival was defined as the time (months) from the date of randomization to the date of disease progression or death (any cause), whichever occurred earlier and was assessed by the Independent Response Adjudication Committee (IRAC). Relapse from complete response (CR) was considered as disease progression throughout the study. Disease progression was determined based on the Revised Response Criteria for Malignant Lymphoma. The PFS analysis was based on the censoring rules using the Food and Drug Administration (FDA) Guidance. Participants who did not experience disease progression and who did not die before the clinical data cutoff date were censored at the date of last adequate response assessment. | The Intent-to-treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Posted | Median | 95% Confidence Interval | months | From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months |
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| Secondary | Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS) | EFS was defined as the time (months) from randomization until occurrence of one of the following events, whichever occurred first: • Disease progression • Initiation of subsequent systemic anti-lymphoma therapy • Death due to any cause The assessment of EFS was conducted by the IRAC using the International Working Group (IWG) criteria for NHL. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as an EFS event (initiation of subsequent systemic anti-lymphoma therapy) if the decision to treat and the location to be treated was determined prior to randomization. Participants who did not experience any of the events defined in the categories above before the clinical data cutoff date were censored at date last known alive. | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Posted | Median | 95% Confidence Interval | Months | From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months |
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| Secondary | K-M Estimate of Overall Survival (OS) | Overall survival was assessed by the Independent Response Adjudication Committee (IRAC) and defined as time from randomization until death due to any cause. Participants who withdrew consent were censored at the time of withdrawal. Participants who were still alive before the clinical data cutoff date and participants who were lost to follow-up were censored at date last known alive. | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Posted | Median | 95% Confidence Interval | Months | From randomization until death due to any cause (up to approximately 86 months) |
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| Secondary | Percentage of Participants Who Achieved a Complete Response (CR) | The percentage of participants who achieved a CR after initiation of the study treatment and prior to initiation of subsequent systemic antilymphoma therapy as assessed by the IRAC. A CR = complete metabolic response; target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow per International Working Group (IWG) 2014 for Non-Hodgkin's Lymphoma (NHL). Participants who did not have any adequate response assessments during this period were not considered as responders. | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a CR. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months |
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| Secondary | Percentage of Participants Who Achieved an Objective Response | An objective response = percentage of participants who achieved a complete response or partial response after initiation of the treatment and prior to initiation of subsequent systemic anti-lymphoma therapy. A CR = complete metabolic response; Target nodes/nodal masses regressed on computed tomography to (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy. Regressed to normal size by imaging, and absence of nodules related to lymphoma. If bone marrow was involved prior to therapy, no evidence of fluorodeoxyglucose avid disease in marrow. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in other nodes, liver, or spleen. Splenic nodules regressed by ≥ 50% in their SPD or for single nodules, in the greatest transverse diameter; no new lesions. Participants who did not have any adequate response assessments during this period were not considered as responders. | The Intent-to-treat population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a PR or better. | Posted | Number | 95% Confidence Interval | Percentage of Participants | From randomization date up to the data cut off date of 15 March 2019; median total treatment duration was 18.10 weeks for both treatment arms; range = 1.6 to 29.0 weeks for R2-CHOP arm and 0.3 to 22.9 weeks for placebo-R-CHOP arm |
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| Secondary | K-M Estimate of Duration of Complete Response | Duration of complete response was calculated for complete responders only and was defined as the time from documented initial complete response prior to initiation of subsequent systemic antilymphoma therapy until documented disease progression or death, whichever occurred earlier. Participants who had not progressed or died at the time of the analysis were censored at the date of last response assessment demonstrating no disease progression. Participants who changed treatment without evidence of disease progression were censored at the last assessment showing no progression prior to treatment change. | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. Participants who had a response. | Posted | Median | 95% Confidence Interval | Months | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months. |
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| Secondary | K-M Estimate of Time to Next Lymphoma Therapy (TTNLT) | Time to next lymphoma therapy was defined as the time from randomization to the time of treatment change for the next lymphoma treatment. Participants without treatment change were censored at date last known alive. Pre-specified optional therapies such as the extra 2 doses of single agent rituximab after Cycle 6 or consolidation radiotherapy did not count as treatment change for the next lymphoma therapy if the decision to treat and the location to be treated were determined prior to randomization. | The Intent-to-treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Posted | Median | 95% Confidence Interval | Months | From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months |
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| Secondary | Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire | The completion rate for FACT-Lym assessments was judged by looking at the number of completed FACT-Lym assessments at each time point. The FACT-Lym was considered completed if at least 1 calculable score was present. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The FACT-Lym is a health related quality of life (HRQoL) questionnaire targeted to the management of chronic illness, predominantly within oncology and is considered an extension of the FACT-General questionnaire. | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Posted | Number | Percentage of Participants | Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
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| Secondary | Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire | The completion rate for EQ-5D assessments was judged by looking at the number of completed assessments at each time point. Completion rates were calculated as the number and percentage of participants out of the total number of patients in the ITT population and summarized by visit/cycle and treatment group. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to "no problems", "some problems" and "extreme problems". The instrument is scored using the United Kingdom (UK) index ranges from -0.594 - 1, where 0 equates to death and 1 equates to full health -0.594 is considered 'worse than death'. | The ITT population was defined as all participants who were randomized into the trial, regardless of whether they received study treatment or not. | Posted | Number | Percentage of Participants | Screening, Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
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| Secondary | Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The physical well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL. | The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit). | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
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| Secondary | Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms such as pain, itching, night sweats,trouble sleeping, fatigue and trouble concentrating and concerns regarding lumps and swelling, fevers, infections, weight, appetite, emotional stability and treatment. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The Additional Concerns subscale ranges from 0 to 60, where higher scores reflect better HRQoL. | The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit). | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
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| Secondary | Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The functional well-being subscale ranges from 0 to 28, where higher scores reflect better HRQoL. | The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit). | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
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| Secondary | Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI) | The FACT-Lym questionnaire is a validated instrument for assessing the impact of lymphoma on HRQL and contains 42 questions covering HRQL and common lymphoma symptoms and treatment side-effects. It begins with the Functional Assessment of Cancer Therapy - General (FACT-G), which contains 27 questions covering four core subscales: Physical Wellbeing (7 items), Social/Family Wellbeing (7), Emotional Wellbeing (6), and Functional Wellbeing (7). The FACT-Lym also includes an Additional Concerns subscale (15 questions) used to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). The FACT-Lym TOI is calculated by summing the Physical Well-being, Functional Well-being and Additional Concerns scores and has a range of 0 to 116. Higher scores reflect better HRQoL or fewer symptoms. | The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable FACT-Lym score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit). | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
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| Secondary | Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score | The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to "no problems", "some problems" and "extreme problems". The instrument is scored as a single summary index using one of the available EQ-5D-3L value sets; in this study the UK scoring weights 9 were used. The UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health (-0.594 is considered 'worse than death'). | The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable EQ-5D score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit). | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
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| Secondary | Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS) | The EQ-5D-3L questionnaire includes a visual analogue scale which records the respondent's self-rated health on a vertical, 0-100 scale where 100 = "Best imaginable health state" and 0 = "Worst imaginable health state". Higher scores again indicate better HRQoL and positive change scores indicate that post screening values were higher than those observed at screening. The EQ-5D-3L is a generic, self-reported preference-based measure of health across five dimensions: mobility, self-care, pain, usual activities, and anxiety/depression. Each dimension has three levels of 'severity' corresponding to "no problems", "some problems" and "extreme problems". | The HRQoL evaluable population was defined as all participants in the ITT population who had: at least one baseline and the corresponding post-baseline calculable EQ-5D score assessment; where post-baseline is any subsequent time excluding unscheduled visits (i.e. at Midcycle, C6D1, EOT or a follow-up visit). | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Midcycle = after Cycle 3 but before Cycle 4, Cycle 6 Day 1 (C6D1), End of Treatment (C6,D21), and Follow-Up Period up to Week 34 |
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Participants were assessed for All-Cause Mortality from the date of their randomization until study completion (assessed up to approximately 86 months). SAEs and Other AEs were monitored from the participant's first dose of study treatment up to 28 days after their last dose of LEN/PBO or any component of R-CHOP including the optional 2 additional doses of rituximab; measured up to approximately 33 weeks.
The number at Risk for All-Cause Mortality represents all Randomized Participants (ITT Population).
Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication (Safety Population).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Lenalidomide Plus R-CHOP (R2-CHOP) | Participants received lenalidomide 15 mg capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 cycles. Treatment continued until completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, whichever occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. | 85 | 285 | 104 | 283 | 272 | 283 |
| EG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. | 88 | 285 | 88 | 284 | 270 | 284 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Cytopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Splenic necrosis | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | 23.0 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | 23.0 | Systematic Assessment |
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| Arrhythmia supraventricular | Cardiac disorders | 23.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | 23.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | 23.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | 23.0 | Systematic Assessment |
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| Cardiac disorder | Cardiac disorders | 23.0 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | 23.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | 23.0 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | 23.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | 23.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Diverticular perforation | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Enterocutaneous fistula | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Gastric haemorrhage | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Gastroduodenal haemorrhage | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Neutropenic colitis | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | 23.0 | Systematic Assessment |
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| Asthenia | General disorders | 23.0 | Systematic Assessment |
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| Death | General disorders | 23.0 | Systematic Assessment |
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| Extravasation | General disorders | 23.0 | Systematic Assessment |
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| Face oedema | General disorders | 23.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | 23.0 | Systematic Assessment |
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| Hypothermia | General disorders | 23.0 | Systematic Assessment |
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| Malaise | General disorders | 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.0 | Systematic Assessment |
| |
| Sudden cardiac death | General disorders | 23.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | 23.0 | Systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | 23.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | 23.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | 23.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | 23.0 | Systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | 23.0 | Systematic Assessment |
| |
| Contrast media allergy | Immune system disorders | 23.0 | Systematic Assessment |
| |
| Abdominal infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Cytomegalovirus infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Groin abscess | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Lower respiratory tract infection bacterial | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Varicella | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Craniofacial fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Procedural nausea | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Procedural vomiting | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.0 | Systematic Assessment |
| |
| Central nervous system lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.0 | Systematic Assessment |
| |
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.0 | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.0 | Systematic Assessment |
| |
| Malignant melanoma in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.0 | Systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 23.0 | Systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Dysarthria | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Guillain-Barre syndrome | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Vocal cord paralysis | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | 23.0 | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | 23.0 | Systematic Assessment |
| |
| Tic | Psychiatric disorders | 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | 23.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Drug eruption | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | 23.0 | Systematic Assessment |
| |
| Thrombophlebitis superficial | Vascular disorders | 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | 23.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | 23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | 23.0 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | 23.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2019 | Feb 18, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| C535900 | Limb-girdle muscular dystrophy, type 2C |
| 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 |
|---|---|
| D000077269 | Lenalidomide |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| 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 |
| 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 |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
|
Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
|
|
| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
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| OG001 | Placebo Plus R-CHOP | Participants received identically matching placebo capsules on days 1 to 14 of each 21 day treatment cycle followed by R-CHOP: rituximab 375 mg/m^2 by intravenous (IV) administration on Day 1, doxorubicin 50 mg/m^2 IV on Day 1, vincristine 1.4 mg/m^2 IV on Day 1 (maximum dose of 2.0 mg total), cyclophosphamide 750 mg/m^2 IV on Day 1 and oral or IV prednisone/prednisolone 100 mg on Day 1 to Day 5 of each 21 day treatment cycle for 6 to 8 cycles. Treatment continued until 6-8 cycles were completed, unless unacceptable toxicity, treatment change, disease progression, or withdrawal of consent, occurred first. An additional two doses (1 dose per 21-day cycle) of single agent rituximab after the 6 cycles of treatment were completed if considered standard of care per local practice. |
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