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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01122472
Registration number
NCT01122472
Ethics application status
Date submitted
8/04/2010
Date registered
13/05/2010
Titles & IDs
Public title
Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP
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Scientific title
Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line
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Secondary ID [1]
0
0
REMARC
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Universal Trial Number (UTN)
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Trial acronym
REMARC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lymphoma
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0
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Diffuse Large B-cell Lymphoma
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0
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Condition category
Condition code
Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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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
Experimental: Lenalidomide - Lenalidomide daily for 3 weeks every 4 weeks for 24 months
Placebo comparator: Placebo - Placebo daily for 3 weeks every 4 weeks for 24 months
Treatment: Drugs: Lenalidomide
Daily for 3 weeks every 4 weeks for 24 months
Treatment: Drugs: Placebo
Daily for 3 weeks every 4 weeks for 24 months
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Intervention code [1]
0
0
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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Progression-Free-Survival (PFS)
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Assessment method [1]
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PFS will be measured from the date of randomization to the date of first documented disease progression or death. Progression data will be assigned to the earliest time when any progression is observed without prior missing assessments during the study up to the end of the follow up phase.
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Timepoint [1]
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Final PFS analysis will be realized when the number of events (160) has been reached or at the latest when the last patient into the study will finish follow up. The approximate schedule will be 75 months after the first patient randomized.
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Secondary outcome [1]
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0
Overall survival (OS)
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Assessment method [1]
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From the date of randomization to the date of death from any cause Interim analysis of OS will be performed at the time of the PFS final analysis; it is projected to have 97 deaths at this time. Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization
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Timepoint [1]
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0
5 years
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Secondary outcome [2]
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Event-Free Survival (EFS)
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Assessment method [2]
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0
From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause Interim analysis of EFS will be performed at the time of the PFS final analysis. Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization
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Timepoint [2]
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5 years
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Secondary outcome [3]
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Response rate at the end of maintenance treatment
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Assessment method [3]
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0
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Timepoint [3]
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24 months
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Secondary outcome [4]
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Percentage of patients who convert from PR (partial response) to CR (complete response)
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Assessment method [4]
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0
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Timepoint [4]
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24 months
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Secondary outcome [5]
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Safety of lenalidomide in maintenance
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Assessment method [5]
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Toxicities occured during maintenance phase will be measured and reported from grade 2 for infection and neurological toxicities and from grade 3 for other toxicities according to CTCAE v3
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Timepoint [5]
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5 years
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Secondary outcome [6]
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PFS2
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Assessment method [6]
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From randomization to objective tumor progression on next-line treatment or death from any cause
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Timepoint [6]
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5 years
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Eligibility
Key inclusion criteria
Ages Eligible for Study: Between 60 and 80 years old
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
For patients registered at the time of initial diagnosis
* Patient with histologically proven CD20+ diffuse large B cel LYMPHOMA (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or CD20+ Aggressive B-cell lymphoma unclassifiable
* previous untreated with chemo- or radiotherapy
For patients registered after response evaluation to first line treatment with R-CHOP:
* Patient with histologically proven CD20+ diffuse large B cell LYMPHOMA (DLBCL) 5WHO classification 2008) including clinical subtypes (primitive mediastinal, intravascular, etc.). Patients with De Novo Transformed DLBCL from low grade lymphoma (Follicular, other..) may also be included. Patients with DLBCL associated with some small cell infiltration in bone marrow may also be included Or CD20+ B-cell lymphoma with intermediate features between DLBCL and Burkitt or with intermediate features between DLBCL and classical Hodgkin lymphoma Or CD20+ Follicular lymphoma grade 3B Or CD20+ Aggressive B-cell lymphoma unclassifiable
* Have reached a CR or PR after first line treatment with at least 6 cycles of R-CHOP 14 regimens and up to 8 cycles of R-CHOP21
* Previously untreated with Radiotherapy
For all patients:
* aged from 60 to 80 years at time of registration
* Ann Arbor stages II-IV at time of initial diagnosis
* aaIPI> 1 at time of initial diagnosis
* ECOG performance status 0-2
* Minimum life expectancy of 3 months
* Following laboratory values at screening:
* ANC= 1000.10^6/L and Platelets=60000.10^6/L
* AST<5*ULN, ALT<5*ULN, Total Bilirubin<1,5*ULN
* Creatinine clearance>30mL/min
* Women are are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and after end of study. Men agree not to father a child during participation in the trial and during the 12 months thereafter.
* Having previously signed a written informed consent form
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Minimum age
60
Years
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Maximum age
80
Years
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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
* Any other histological type of Lymphoma, Burkitt included.
* Any history of treated or non treated small B-cell lymphoma
* Central nervous system or meningeal involvement by lymphoma
* Contraindication to any drug contained in the chemotherapy regimen Myocardial infarction during last 3 months or unstable coronary disease or uncontrolled chronic symptomatic congestive heart insufficiency NYHA III-IV
* Uncontrolled hypertension
* Uncontrolled diabetes mellitus as defined by the investigator
* Active systemic infection requiring treatment
* previously known HIV positive serology
* Active hepatitis B or C
* Prior history of malignancies other than lymphoma within 3 years
* Serious medical or psychiatric illness
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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
1/04/2009
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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
1/09/2019
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Sample size
Target
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Accrual to date
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Final
650
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Bendigo Hospital - Bendigo
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Concord Repatriation General Hospital - Concord
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Flinders Medical Centre - Repatriation General Hospital - Daw Park
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St Vincent's Hospital, Melbourne - Fitzroy
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Frankston Hospital Monash Medical Centre - Frankston
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Fremantle Hospital - Fremantle
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Canberra Hospital - Garran
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Austin Hospital - Heidelberg
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Royal Hobart Hospital - Hobart
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Mater Misericordiae Hospital - Calvary Mater NewCastle - Hunter
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St George Hospital - Kogarah
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Sir Charles Gardiner Hospital - Nedlands
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Gold Coast Hospital - Southport
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Albury Base Hospital/Murray Valley Private Hospital - Wodonga
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Queen Elizabeth Hospital - Woodville
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3550 - Bendigo
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2139 - Concord
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5000 - Daw Park
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3065 - Fitzroy
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3199 - Frankston
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6160 - Fremantle
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2606 - Garran
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69126 - Heidelberg
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7000 - Hobart
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2310 - Hunter
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2217 - Kogarah
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6009 - Nedlands
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4215 - Southport
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3690 - Wodonga
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Recruitment postcode(s) [15]
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5011 - Woodville
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Recruitment outside Australia
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Austria
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Feldkirch
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Linz
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Israel
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State/province [102]
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Petah Tikwah
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Israel
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Rehovot
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Poland
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Chorzow
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Country [105]
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Poland
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Krakow
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Poland
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State/province [106]
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Lodz
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Poland
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Warsaw
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Poland
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State/province [108]
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Warszawa
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Portugal
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State/province [109]
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Coimbra
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Portugal
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State/province [110]
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Lisboa
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Portugal
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State/province [111]
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Porto
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Spain
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State/province [112]
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A coruna
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Spain
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State/province [113]
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Alcorcon
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Spain
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State/province [114]
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Barcelona
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Spain
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State/province [115]
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El palmar
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Spain
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State/province [116]
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Jerez de la frontera
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Spain
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Leon
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Oviedo
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Tarragona
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Spain
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Terrassa
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Country [125]
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Switzerland
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Lausanne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Lymphoma Academic Research Organisation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.
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Trial website
https://clinicaltrials.gov/study/NCT01122472
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Trial related presentations / publications
Cottereau AS, Meignan M, Nioche C, Capobianco N, Clerc J, Chartier L, Vercellino L, Casasnovas O, Thieblemont C, Buvat I. Risk stratification in diffuse large B-cell lymphoma using lesion dissemination and metabolic tumor burden calculated from baseline PET/CTdagger. Ann Oncol. 2021 Mar;32(3):404-411. doi: 10.1016/j.annonc.2020.11.019. Epub 2020 Dec 3. Vercellino L, Cottereau AS, Casasnovas O, Tilly H, Feugier P, Chartier L, Fruchart C, Roulin L, Oberic L, Pica GM, Ribrag V, Abraham J, Simon M, Gonzalez H, Bouabdallah R, Fitoussi O, Sebban C, Lopez-Guillermo A, Sanhes L, Morschhauser F, Trotman J, Corront B, Choufi B, Snauwaert S, Godmer P, Briere J, Salles G, Gaulard P, Meignan M, Thieblemont C. High total metabolic tumor volume at baseline predicts survival independent of response to therapy. Blood. 2020 Apr 16;135(16):1396-1405. doi: 10.1182/blood.2019003526.
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01122472