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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
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
Secondary ID [1] 0 0
REMARC
Universal Trial Number (UTN)
Trial acronym
REMARC
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Placebo

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

Outcomes
Primary outcome [1] 0 0
Progression-Free-Survival (PFS)
Timepoint [1] 0 0
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.
Secondary outcome [1] 0 0
Overall survival (OS)
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Event-Free Survival (EFS)
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Response rate at the end of maintenance treatment
Timepoint [3] 0 0
24 months
Secondary outcome [4] 0 0
Percentage of patients who convert from PR (partial response) to CR (complete response)
Timepoint [4] 0 0
24 months
Secondary outcome [5] 0 0
Safety of lenalidomide in maintenance
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
PFS2
Timepoint [6] 0 0
5 years

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
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
1/04/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2019
Sample size
Target
Accrual to date
Final
650
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Flinders Medical Centre - Repatriation General Hospital - Daw Park
Recruitment hospital [4] 0 0
St Vincent's Hospital, Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Frankston Hospital Monash Medical Centre - Frankston
Recruitment hospital [6] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [7] 0 0
Canberra Hospital - Garran
Recruitment hospital [8] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [9] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [10] 0 0
Mater Misericordiae Hospital - Calvary Mater NewCastle - Hunter
Recruitment hospital [11] 0 0
St George Hospital - Kogarah
Recruitment hospital [12] 0 0
Sir Charles Gardiner Hospital - Nedlands
Recruitment hospital [13] 0 0
Gold Coast Hospital - Southport
Recruitment hospital [14] 0 0
Albury Base Hospital/Murray Valley Private Hospital - Wodonga
Recruitment hospital [15] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
3550 - Bendigo
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
5000 - Daw Park
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3199 - Frankston
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment postcode(s) [7] 0 0
2606 - Garran
Recruitment postcode(s) [8] 0 0
69126 - Heidelberg
Recruitment postcode(s) [9] 0 0
7000 - Hobart
Recruitment postcode(s) [10] 0 0
2310 - Hunter
Recruitment postcode(s) [11] 0 0
2217 - Kogarah
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
4215 - Southport
Recruitment postcode(s) [14] 0 0
3690 - Wodonga
Recruitment postcode(s) [15] 0 0
5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Feldkirch
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Leoben
Country [4] 0 0
Austria
State/province [4] 0 0
Linz
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Austria
State/province [6] 0 0
Steyr
Country [7] 0 0
Austria
State/province [7] 0 0
Vienna
Country [8] 0 0
Austria
State/province [8] 0 0
Wels
Country [9] 0 0
Belgium
State/province [9] 0 0
Antwerpen
Country [10] 0 0
Belgium
State/province [10] 0 0
Arlon
Country [11] 0 0
Belgium
State/province [11] 0 0
Bruges
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Charleroi
Country [14] 0 0
Belgium
State/province [14] 0 0
Chimay
Country [15] 0 0
Belgium
State/province [15] 0 0
Gent
Country [16] 0 0
Belgium
State/province [16] 0 0
Gosselies
Country [17] 0 0
Belgium
State/province [17] 0 0
Haine saint paul
Country [18] 0 0
Belgium
State/province [18] 0 0
HUY
Country [19] 0 0
Belgium
State/province [19] 0 0
Jette
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Belgium
State/province [20] 0 0
Kortrijk
Country [21] 0 0
Belgium
State/province [21] 0 0
Liege
Country [22] 0 0
Belgium
State/province [22] 0 0
Mons
Country [23] 0 0
Belgium
State/province [23] 0 0
Namur
Country [24] 0 0
Belgium
State/province [24] 0 0
Ottignies
Country [25] 0 0
Belgium
State/province [25] 0 0
Roeselare
Country [26] 0 0
Belgium
State/province [26] 0 0
Verviers
Country [27] 0 0
Belgium
State/province [27] 0 0
Wilrijk
Country [28] 0 0
Belgium
State/province [28] 0 0
Yvoir
Country [29] 0 0
France
State/province [29] 0 0
Annecy Cedex
Country [30] 0 0
France
State/province [30] 0 0
Antibes
Country [31] 0 0
France
State/province [31] 0 0
Arras Cedex
Country [32] 0 0
France
State/province [32] 0 0
Avignon
Country [33] 0 0
France
State/province [33] 0 0
Bayonne
Country [34] 0 0
France
State/province [34] 0 0
Blois
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France
State/province [35] 0 0
Bobigny
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France
State/province [36] 0 0
BONDY Cedex
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France
State/province [37] 0 0
Bordeaux
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France
State/province [38] 0 0
Boulogne sur Mer
Country [39] 0 0
France
State/province [39] 0 0
Bourg-en-Bresse
Country [40] 0 0
France
State/province [40] 0 0
Brive-La-Gaillarde
Country [41] 0 0
France
State/province [41] 0 0
CAEN Cedex 05
Country [42] 0 0
France
State/province [42] 0 0
Caen Cedex
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France
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Cannes
Country [44] 0 0
France
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Chalon sur Saone
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France
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Chambery
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France
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Chartres Cedex
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France
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Clamart
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France
State/province [48] 0 0
Colmar Cedex
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France
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Compiegne Cedex
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France
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Corbeil-Essonnes
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Créteil
Country [52] 0 0
France
State/province [52] 0 0
Dijon
Country [53] 0 0
France
State/province [53] 0 0
Dunkerque
Country [54] 0 0
France
State/province [54] 0 0
Evreux
Country [55] 0 0
France
State/province [55] 0 0
Frejus
Country [56] 0 0
France
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Grenoble
Country [57] 0 0
France
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Gueret
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France
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La Rochelle Cedex 01
Country [59] 0 0
France
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Le Chesnay
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France
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Le Kremlin-Bicêtre
Country [61] 0 0
France
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LE Mans
Country [62] 0 0
France
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Lens
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France
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Lille Cedex
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France
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Lille
Country [65] 0 0
France
State/province [65] 0 0
LIMOGES Cedex
Country [66] 0 0
France
State/province [66] 0 0
LYON Cedex 08
Country [67] 0 0
France
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Lyon
Country [68] 0 0
France
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Macon Cedex
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France
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Marseille Cedex
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Marseille
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Meaux
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MELUN Cedex
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Metz Cedex
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Montpellier Cedex
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Mougins
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France
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MULHOUSE Cedex
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France
State/province [77] 0 0
Neuilly sur seine
Country [78] 0 0
France
State/province [78] 0 0
Nice
Country [79] 0 0
France
State/province [79] 0 0
Paris Cedex 04
Country [80] 0 0
France
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Paris Cedex 05
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France
State/province [81] 0 0
Paris Cedex 13
Country [82] 0 0
France
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Paris
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France
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Perpignan
Country [84] 0 0
France
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Pierre Bénite Cedex
Country [85] 0 0
France
State/province [85] 0 0
Pontoise
Country [86] 0 0
France
State/province [86] 0 0
REIMS Cedex
Country [87] 0 0
France
State/province [87] 0 0
Rouen
Country [88] 0 0
France
State/province [88] 0 0
Saint Cloud Cedex
Country [89] 0 0
France
State/province [89] 0 0
St Germain en Laye
Country [90] 0 0
France
State/province [90] 0 0
Toulon
Country [91] 0 0
France
State/province [91] 0 0
Toulouse Cedex 9
Country [92] 0 0
France
State/province [92] 0 0
Troyes Cedex
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France
State/province [93] 0 0
Valence Cedex 9
Country [94] 0 0
France
State/province [94] 0 0
Valenciennes
Country [95] 0 0
France
State/province [95] 0 0
Vandœuvre-lès-Nancy
Country [96] 0 0
France
State/province [96] 0 0
VILLEJUIF Cedex
Country [97] 0 0
Israel
State/province [97] 0 0
Afula
Country [98] 0 0
Israel
State/province [98] 0 0
Ashkelon
Country [99] 0 0
Israel
State/province [99] 0 0
Beer sheva
Country [100] 0 0
Israel
State/province [100] 0 0
Haifa
Country [101] 0 0
Israel
State/province [101] 0 0
Kfar saba
Country [102] 0 0
Israel
State/province [102] 0 0
Petah Tikwah
Country [103] 0 0
Israel
State/province [103] 0 0
Rehovot
Country [104] 0 0
Poland
State/province [104] 0 0
Chorzow
Country [105] 0 0
Poland
State/province [105] 0 0
Krakow
Country [106] 0 0
Poland
State/province [106] 0 0
Lodz
Country [107] 0 0
Poland
State/province [107] 0 0
Warsaw
Country [108] 0 0
Poland
State/province [108] 0 0
Warszawa
Country [109] 0 0
Portugal
State/province [109] 0 0
Coimbra
Country [110] 0 0
Portugal
State/province [110] 0 0
Lisboa
Country [111] 0 0
Portugal
State/province [111] 0 0
Porto
Country [112] 0 0
Spain
State/province [112] 0 0
A coruna
Country [113] 0 0
Spain
State/province [113] 0 0
Alcorcon
Country [114] 0 0
Spain
State/province [114] 0 0
Barcelona
Country [115] 0 0
Spain
State/province [115] 0 0
El palmar
Country [116] 0 0
Spain
State/province [116] 0 0
Jerez de la frontera
Country [117] 0 0
Spain
State/province [117] 0 0
Leon
Country [118] 0 0
Spain
State/province [118] 0 0
Madrid
Country [119] 0 0
Spain
State/province [119] 0 0
Murcia
Country [120] 0 0
Spain
State/province [120] 0 0
Oviedo
Country [121] 0 0
Spain
State/province [121] 0 0
Salamanca
Country [122] 0 0
Spain
State/province [122] 0 0
Santander
Country [123] 0 0
Spain
State/province [123] 0 0
Tarragona
Country [124] 0 0
Spain
State/province [124] 0 0
Terrassa
Country [125] 0 0
Switzerland
State/province [125] 0 0
Lausanne

Funding & Sponsors
Primary sponsor type
Other
Name
The Lymphoma Academic Research Organisation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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