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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02285062




Registration number
NCT02285062
Ethics application status
Date submitted
4/11/2014
Date registered
6/11/2014
Date last updated
31/03/2020

Titles & IDs
Public title
Efficacy and Safety Study of Lenalidomide Plus R-CHOP Chemotherapy Versus Placebo Plus R-CHOP Chemotherapy in Untreated ABC Type Diffuse Large B-cell Lymphoma
Scientific title
Phase 3 Randomized, Double-Blind, Placebo Controlled, Multicenter Study to Compare the Efficacy and Safety of Lenalidomide (CC-5013) Plus R-CHOP Chemotherapy (R2-CHOP) Versus Placebo Plus R-CHOP Chemotherapy in Subjects With Previously Untreated Activated B-cell Type Diffuse Large B-cell Lymphoma
Secondary ID [1] 0 0
2013-004054-21
Secondary ID [2] 0 0
CC-5013-DLC-002
Universal Trial Number (UTN)
Trial acronym
ROBUST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Large B-Cell, Diffuse 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lenalidomide
Treatment: Drugs - Placebo
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - prednisone
Treatment: Drugs - vincristine

Experimental: R2-CHOP - Lenalidomide plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)

Active Comparator: R-CHOP - Placebo plus R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)


Treatment: Drugs: lenalidomide


Treatment: Drugs: Placebo


Treatment: Drugs: Rituximab


Treatment: Drugs: Cyclophosphamide


Treatment: Drugs: Doxorubicin


Treatment: Drugs: prednisone


Treatment: Drugs: vincristine


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
From the date of randomization up to the data cut off date of 15 March 2019; median follow-up of 24.5 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
Secondary outcome [2] 0 0
K-M Estimate of Overall Survival (OS) - Overall survival was assessed by the IRAC and defined as time from randomization until death of 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.
Timepoint [2] 0 0
From the date of randomization up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months.
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
From randomization date up to the data cut off date of 15 March 2019; median follow-up was 24.5 months
Secondary outcome [7] 0 0
Number of Participants With a Treatment Emergent Adverse Event (TEAE) - A TEAE was defined as an AE that begins or worsens in intensity or frequency on or after the first dose of study drug through 28 days after last dose of study drug.
A serious adverse event (SAE) is any:
Death;
Life-threatening event;
Any inpatient hospitalization or prolongation of existing hospitalization;
Persistent or significant disability or incapacity;
Congenital anomaly or birth defect;
Any other important medical event The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide a sufficient explanation for the event. The severity of an AE was evaluated by the investigator according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) (Version 4.0) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death
Timepoint [7] 0 0
From the first dose of study treatment up to 28 days after the last dose of LEN/placebo or any component of R-CHOP including the optional 2 additional doses of rituximab if administered; up to 15 March 2019; maximum treatment duration = 29 months
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
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'.
Timepoint [9] 0 0
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
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
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.
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
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.
Timepoint [13] 0 0
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
Secondary outcome [14] 0 0
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').
Timepoint [14] 0 0
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
Secondary outcome [15] 0 0
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".
Timepoint [15] 0 0
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

Eligibility
Key inclusion criteria
1. Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type

2. Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma

3. Measurable Diffuse Large B-Cell Lymphoma disease by Computed Tomography (CT) /
Magnetic Resonance Imagining (MRI) scans

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

5. Age 18 - 80 years; age > 80 allowed at investigator discretion if performance status =
1; and each organ system score = 2 using cumulative illness rating scale (CIRS)
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma

2. History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient
has been disease free for 5 years or more

3. Known seropositive for, or history of, active Human Immunodeficiency Virus (HIV)
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV)

4. Contraindication to any drug in the chemotherapy regimen, and specifically: LVEF (Left
Ventricular Ejection Fraction) < 45% or peripheral neuropathy grade 2

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Albury Wodonga Regional Cancer Centre - Albury
Recruitment hospital [2] 0 0
Shoalhaven Cancer Care Centre - Nowra
Recruitment hospital [3] 0 0
Bendigo Hosp - Bendigo
Recruitment hospital [4] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [5] 0 0
Geelong Hospital - Geelong
Recruitment hospital [6] 0 0
St Vincents Hospital Melbourne - Fitzroy
Recruitment hospital [7] 0 0
Frankston Hospital - Frankston
Recruitment hospital [8] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
Wellington Hospital - Wellington
Recruitment hospital [11] 0 0
Westmead Hospital - Westmead
Recruitment hospital [12] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2541 - Nowra
Recruitment postcode(s) [3] 0 0
3550 - Bendigo
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment postcode(s) [8] 0 0
3084 - Heidelberg
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
6021 - Wellington
Recruitment postcode(s) [11] 0 0
NSW 2145 - Westmead
Recruitment postcode(s) [12] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Belgium
State/province [24] 0 0
Brussels
Country [25] 0 0
Belgium
State/province [25] 0 0
Liege
Country [26] 0 0
Belgium
State/province [26] 0 0
Roeselare
Country [27] 0 0
Belgium
State/province [27] 0 0
Sint-Niklaas
Country [28] 0 0
Belgium
State/province [28] 0 0
West-Vlaanderen
Country [29] 0 0
Belgium
State/province [29] 0 0
Wilrijk
Country [30] 0 0
Belgium
State/province [30] 0 0
Yvoir
Country [31] 0 0
Canada
State/province [31] 0 0
Alberta
Country [32] 0 0
Canada
State/province [32] 0 0
British Columbia
Country [33] 0 0
Canada
State/province [33] 0 0
New Brunswick
Country [34] 0 0
Canada
State/province [34] 0 0
Ontario
Country [35] 0 0
Canada
State/province [35] 0 0
Quebec
Country [36] 0 0
Canada
State/province [36] 0 0
Saskatchewan
Country [37] 0 0
China
State/province [37] 0 0
Beijing, PR
Country [38] 0 0
China
State/province [38] 0 0
Beijing
Country [39] 0 0
China
State/province [39] 0 0
Changchun
Country [40] 0 0
China
State/province [40] 0 0
Chengdu
Country [41] 0 0
China
State/province [41] 0 0
Chongqing
Country [42] 0 0
China
State/province [42] 0 0
Fuzhou
Country [43] 0 0
China
State/province [43] 0 0
Guangzhou, Guangdong
Country [44] 0 0
China
State/province [44] 0 0
Guangzhou
Country [45] 0 0
China
State/province [45] 0 0
Hangzhou
Country [46] 0 0
China
State/province [46] 0 0
Harbin, Heilongjiang
Country [47] 0 0
China
State/province [47] 0 0
Nanjing, Jiangsu
Country [48] 0 0
China
State/province [48] 0 0
Nanjing
Country [49] 0 0
China
State/province [49] 0 0
Shanghai
Country [50] 0 0
China
State/province [50] 0 0
Suzhu
Country [51] 0 0
China
State/province [51] 0 0
Tianjin
Country [52] 0 0
China
State/province [52] 0 0
Wuhan
Country [53] 0 0
Czechia
State/province [53] 0 0
Brno
Country [54] 0 0
Czechia
State/province [54] 0 0
Hradec Kralove
Country [55] 0 0
Czechia
State/province [55] 0 0
Olomouc
Country [56] 0 0
Czechia
State/province [56] 0 0
Prague 10
Country [57] 0 0
Czechia
State/province [57] 0 0
Praha
Country [58] 0 0
France
State/province [58] 0 0
Bayonne
Country [59] 0 0
France
State/province [59] 0 0
Bordeaux
Country [60] 0 0
France
State/province [60] 0 0
Brest Cedex
Country [61] 0 0
France
State/province [61] 0 0
Creteil
Country [62] 0 0
France
State/province [62] 0 0
La Roche -Sur-Yon - Cedex 9
Country [63] 0 0
France
State/province [63] 0 0
Montepellier Cedex 5
Country [64] 0 0
France
State/province [64] 0 0
Nantes
Country [65] 0 0
France
State/province [65] 0 0
Paris Cedex 15
Country [66] 0 0
France
State/province [66] 0 0
Paris
Country [67] 0 0
France
State/province [67] 0 0
Pessac Cedex
Country [68] 0 0
France
State/province [68] 0 0
Pringy
Country [69] 0 0
France
State/province [69] 0 0
Rennes
Country [70] 0 0
France
State/province [70] 0 0
ST-Brieuc cedex 1
Country [71] 0 0
France
State/province [71] 0 0
Toulose
Country [72] 0 0
France
State/province [72] 0 0
Vandoeuvre les Nancy
Country [73] 0 0
France
State/province [73] 0 0
Villejuif CEDEX
Country [74] 0 0
Ireland
State/province [74] 0 0
Cork
Country [75] 0 0
Ireland
State/province [75] 0 0
Dublin 4
Country [76] 0 0
Ireland
State/province [76] 0 0
Dublin 8
Country [77] 0 0
Ireland
State/province [77] 0 0
Dublin
Country [78] 0 0
Ireland
State/province [78] 0 0
Galway
Country [79] 0 0
Israel
State/province [79] 0 0
Beer-Sheva
Country [80] 0 0
Israel
State/province [80] 0 0
Haifa
Country [81] 0 0
Israel
State/province [81] 0 0
Jerusalem
Country [82] 0 0
Israel
State/province [82] 0 0
Kfar-Saba
Country [83] 0 0
Israel
State/province [83] 0 0
Petach Tikva
Country [84] 0 0
Israel
State/province [84] 0 0
Ramat Gan
Country [85] 0 0
Israel
State/province [85] 0 0
Tel Aviv
Country [86] 0 0
Israel
State/province [86] 0 0
Tel-Aviv
Country [87] 0 0
Israel
State/province [87] 0 0
Zerifin
Country [88] 0 0
Italy
State/province [88] 0 0
Allessandria
Country [89] 0 0
Italy
State/province [89] 0 0
Ancona
Country [90] 0 0
Italy
State/province [90] 0 0
Aviano
Country [91] 0 0
Italy
State/province [91] 0 0
Bari
Country [92] 0 0
Italy
State/province [92] 0 0
Bologna
Country [93] 0 0
Italy
State/province [93] 0 0
Brescia
Country [94] 0 0
Italy
State/province [94] 0 0
Catania
Country [95] 0 0
Italy
State/province [95] 0 0
Cuneo
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Italy
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Italy
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Italy
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Italy
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Kayseri

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02285062
Trial related presentations / publications
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.
Public notes

Contacts
Principal investigator
Name 0 0
Stacey Kalambakas, M.D
Address 0 0
Celgene Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications