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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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
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)
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Kaplan-Meier Estimate of Progression Free Survival (PFS)
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)
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)
Timepoint [2] 0 0
From randomization until death due to any cause (up to approximately 86 months)
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved a Complete Response (CR)
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
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
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)
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
Percentage of Participants Who Completed the Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Questionnaire
Timepoint [7] 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 [8] 0 0
Percentage of Participants Who Completed the Euroqol 5-Dimension 3-Level (EQ-5D-3L) Health Related Quality of Life (HR-QoL) 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
Mean Change From Baseline in the FACT-Lym Physical Well-Being Subscale
Timepoint [9] 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 [10] 0 0
Mean Change From Baseline in the FACT-Lym Additional Concerns Subscale
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 Functional Well-Being Subscale
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 Trial Outcome Index (TOI)
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 Euroqol 5-Dimension 3-Level (EQ-5D-3L) Index Score
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 EQ-5D-3L Visual Analogue Scale (VAS)
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

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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/07/2022
Sample size
Target
Accrual to date
Final
570
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Local Institution - 004 - Albury
Recruitment hospital [2] 0 0
Local Institution - 008 - Clayton
Recruitment hospital [3] 0 0
Local Institution - 002 - Geelong
Recruitment hospital [4] 0 0
Local Institution - 003 - Frankston
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3199 - Frankston
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
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
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Louisiana
Country [8] 0 0
United States of America
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Maryland
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United States of America
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Minnesota
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United States of America
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North Carolina
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Pennsylvania
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Texas
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United States of America
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Utah
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United States of America
State/province [14] 0 0
Washington
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Belgium
State/province [15] 0 0
Brussels
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Belgium
State/province [16] 0 0
Liege
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Belgium
State/province [17] 0 0
Roeselare
Country [18] 0 0
Belgium
State/province [18] 0 0
Sint-Niklaas
Country [19] 0 0
Canada
State/province [19] 0 0
Alberta
Country [20] 0 0
Canada
State/province [20] 0 0
British Columbia
Country [21] 0 0
Canada
State/province [21] 0 0
New Brunswick
Country [22] 0 0
Canada
State/province [22] 0 0
Quebec
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China
State/province [23] 0 0
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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Czechia
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Praha
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France
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Bayonne
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Bordeaux
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France
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Montpellier
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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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Kfar-Saba
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Israel
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Petach Tikva
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Israel
State/province [56] 0 0
Tel-Aviv
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Zerifin
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Italy
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Umbria
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Allessandria
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Italy
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Brescia
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Italy
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Cuneo
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Italy
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Firenze
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Italy
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Genova
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Ivrea
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Meldola
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Milano
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Italy
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Napoli, Campania
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Novara
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Italy
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Padova
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Italy
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Pagani
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Pavia
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Ravenna
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Reggio Emilia
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Rimini
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Roma
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Rome
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Torino
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Tricase
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Udine
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Verona
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Vicenza
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Akita-shi
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Fukuoka
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Isehara City, Kanagawa
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Kashiwa
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Japan
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Kyoto-City
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Japan
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Minami-Ku, Fukuoka
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Japan
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Nagoya
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Japan
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Sendai-city
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Yamagata
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Korea, Republic of
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Gyeonggi-do
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Seoul
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Netherlands
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Amsterdam
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Breda
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Hoofddorp
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Leeuwarden
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s-Hertogenbosch
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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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Portugal
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Figueira da Foz
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Portugal
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Lisboa
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Portugal
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Pragal
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Puerto Rico
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San Juan
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Spain
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Barcelona
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Spain
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Caceres
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Sevilla
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Spain
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Valencia
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Switzerland
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Bellinzona
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Switzerland
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Geneva
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Switzerland
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Winterthur
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Taiwan
State/province [118] 0 0
Niao-Sung Hsiang Kaohsiung County
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Taiwan
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Taichung City
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Taiwan
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Taipei, Zhongzheng Dist.
Country [121] 0 0
Turkey
State/province [121] 0 0
Adana
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Turkey
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Ankara
Country [123] 0 0
Turkey
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Antalya
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Turkey
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Denizli
Country [125] 0 0
Turkey
State/province [125] 0 0
Edirne
Country [126] 0 0
Turkey
State/province [126] 0 0
Istanbul

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/study/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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02285062