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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02285062
Registration number
NCT02285062
Ethics application status
Date submitted
4/11/2014
Date registered
6/11/2014
Date last updated
22/06/2023
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
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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
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Secondary ID [1]
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2013-004054-21
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Secondary ID [2]
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CC-5013-DLC-002
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Universal Trial Number (UTN)
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Trial acronym
ROBUST
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma, Large B-Cell, Diffuse
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Kaplan-Meier Estimate of Progression Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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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 outcome [1]
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Kaplan-Meier (K-M) Estimate of Event Free Survival (EFS)
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Assessment method [1]
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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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Timepoint [1]
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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
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Secondary outcome [2]
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K-M Estimate of Overall Survival (OS)
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Assessment method [2]
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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.
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Timepoint [2]
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From randomization until death due to any cause (up to approximately 86 months)
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Secondary outcome [3]
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Percentage of Participants Who Achieved a Complete Response (CR)
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Assessment method [3]
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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.
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Timepoint [3]
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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 outcome [4]
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Percentage of Participants Who Achieved an Objective Response
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Assessment method [4]
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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.
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Timepoint [4]
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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 outcome [5]
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K-M Estimate of Duration of Complete Response
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Assessment method [5]
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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.
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Timepoint [5]
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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 outcome [6]
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K-M Estimate of Time to Next Lymphoma Therapy (TTNLT)
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Assessment method [6]
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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.
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Timepoint [6]
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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 outcome [7]
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Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire
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Assessment method [7]
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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.
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Timepoint [7]
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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 outcome [8]
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Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) Questionnaire
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Assessment method [8]
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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'.
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Timepoint [8]
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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 outcome [9]
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Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale
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Assessment method [9]
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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.
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Timepoint [9]
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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 outcome [10]
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Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale
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Assessment method [10]
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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.
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Timepoint [10]
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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 outcome [11]
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Mean Change From Baseline in the FACT-Lym Functional Well-Being Subscale
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Assessment method [11]
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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.
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Timepoint [11]
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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 outcome [12]
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Mean Change From Baseline in the FACT-Lym Trial Outcome Index (TOI)
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Assessment method [12]
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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.
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Timepoint [12]
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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 outcome [13]
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Mean Change From Baseline in the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score
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Assessment method [13]
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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').
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Timepoint [13]
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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 outcome [14]
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Mean Change From Baseline in the EQ-5D-3L Visual Analogue Scale (VAS)
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Assessment method [14]
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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".
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Timepoint [14]
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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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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)
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Minimum age
18
Years
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/02/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/07/2022
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Sample size
Target
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Accrual to date
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Final
570
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Local Institution - 004 - Albury
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Recruitment hospital [2]
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Local Institution - 008 - Clayton
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Recruitment hospital [3]
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Local Institution - 002 - Geelong
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Recruitment hospital [4]
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Local Institution - 003 - Frankston
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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United States of America
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California
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United States of America
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Connecticut
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Florida
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Iowa
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United States of America
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Kansas
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United States of America
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Louisiana
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Maryland
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Minnesota
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North Carolina
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Pennsylvania
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Texas
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Utah
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United States of America
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Washington
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Belgium
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Brussels
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Belgium
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Liege
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Belgium
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Roeselare
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Belgium
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Sint-Niklaas
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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New Brunswick
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Canada
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Quebec
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China
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Beijing
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China
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Changchun
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China
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Chengdu
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China
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Chongqing
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China
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Fuzhou
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China
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Guangzhou, Guangdong
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China
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Hangzhou
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China
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Harbin, Heilongjiang
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China
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Nanjing, Jiangsu
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China
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Nanjing
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China
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Shanghai
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China
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Suzhu
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China
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Tianjin
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China
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Wuhan
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Olomouc
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Czechia
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Prague 10
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Praha
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France
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Bayonne
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France
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Bordeaux
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France
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France
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Paris
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France
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Pessac Cedex
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France
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Toulose
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France
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Vandoeuvre les Nancy
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Ireland
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Dublin 4
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Ireland
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Galway
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Israel
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Beer-Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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State/province [54]
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Kfar-Saba
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Country [55]
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Israel
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State/province [55]
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Petach Tikva
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Country [56]
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Israel
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Tel-Aviv
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Country [57]
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Israel
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0
Zerifin
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Country [58]
0
0
Italy
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State/province [58]
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0
Umbria
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Country [59]
0
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Italy
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State/province [59]
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Allessandria
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Country [60]
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Italy
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Brescia
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Country [61]
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Italy
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Cuneo
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Country [62]
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Italy
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Firenze
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Country [63]
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Italy
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Genova
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Country [64]
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Italy
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Ivrea
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Country [65]
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Italy
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Meldola
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Country [66]
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Italy
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Milano
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Country [67]
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Italy
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Napoli, Campania
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Italy
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Novara
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Country [69]
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Italy
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Padova
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Country [70]
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Italy
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Pagani
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Country [71]
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Italy
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Pavia
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Country [72]
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Italy
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Ravenna
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Country [73]
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Italy
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Reggio Emilia
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Italy
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Rimini
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Italy
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Roma
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Italy
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Rome
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Country [77]
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Italy
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Torino
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Country [78]
0
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Italy
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State/province [78]
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Tricase
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Country [79]
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Italy
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Udine
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Country [80]
0
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Italy
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Verona
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Country [81]
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Italy
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Vicenza
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Japan
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Tokyo
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Japan
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Akita-shi
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Japan
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Fukuoka
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Country [85]
0
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Japan
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State/province [85]
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Isehara City, Kanagawa
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Country [86]
0
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Japan
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State/province [86]
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Kashiwa
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Country [87]
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Japan
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State/province [87]
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Kyoto-City
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Country [88]
0
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Japan
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State/province [88]
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Minami-Ku, Fukuoka
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Country [89]
0
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Japan
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State/province [89]
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Nagoya
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Country [90]
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Japan
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Sendai-city
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Country [91]
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Japan
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State/province [91]
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Yamagata
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Country [92]
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Country [94]
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Country [96]
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Netherlands
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State/province [96]
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Hoofddorp
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Country [97]
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Netherlands
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State/province [97]
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Leeuwarden
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Country [98]
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Netherlands
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s-Hertogenbosch
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Netherlands
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Schiedam
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New Zealand
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Christchurch
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New Zealand
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Palmerston
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Country [102]
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Portugal
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State/province [102]
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Figueira da Foz
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Country [103]
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Portugal
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State/province [103]
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Lisboa
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Country [104]
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Portugal
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Pragal
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Country [105]
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Puerto Rico
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State/province [105]
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San Juan
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Country [106]
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Russian Federation
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Kazan
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Country [107]
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Russian Federation
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Moscow
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Country [108]
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Russian Federation
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St. Petersburg
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Country [109]
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Spain
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Barcelona
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Country [110]
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Spain
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Caceres
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Country [111]
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Spain
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Madrid
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Country [112]
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Spain
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Salamanca
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Country [113]
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Spain
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State/province [113]
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Sevilla
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Country [114]
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Spain
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State/province [114]
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Valencia
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Country [115]
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Switzerland
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State/province [115]
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Bellinzona
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Country [116]
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Switzerland
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State/province [116]
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Geneva
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Country [117]
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Switzerland
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State/province [117]
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Winterthur
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Country [118]
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Taiwan
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State/province [118]
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Niao-Sung Hsiang Kaohsiung County
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Country [119]
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Taiwan
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State/province [119]
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Taichung City
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Country [120]
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Taiwan
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Taipei, Zhongzheng Dist.
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Country [121]
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Turkey
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Adana
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Country [122]
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Turkey
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State/province [122]
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Ankara
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Country [123]
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Turkey
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Antalya
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Country [124]
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Turkey
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Denizli
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Country [125]
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Turkey
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Edirne
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Turkey
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02285062
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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.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02285062
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