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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
Date last updated
26/07/2021

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
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Austria
State/province [3] 0 0
Leoben
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Austria
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Linz
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Austria
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Salzburg
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Austria
State/province [6] 0 0
Steyr
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Austria
State/province [7] 0 0
Vienna
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Austria
State/province [8] 0 0
Wels
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Belgium
State/province [9] 0 0
Antwerpen
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Belgium
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Arlon
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Belgium
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Bruges
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Belgium
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Bruxelles
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Belgium
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Charleroi
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Belgium
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Chimay
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Belgium
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Gent
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Belgium
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Gosselies
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Belgium
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Haine saint paul
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Belgium
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HUY
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Jette
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Kortrijk
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Belgium
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Liege
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Belgium
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Mons
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Belgium
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Namur
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Belgium
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Ottignies
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Belgium
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Roeselare
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Verviers
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Belgium
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Wilrijk
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Belgium
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Yvoir
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France
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Annecy Cedex
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France
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Antibes
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France
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Arras Cedex
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Avignon
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Bayonne
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Bourg-en-Bresse
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Meaux
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Mougins
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REIMS Cedex
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Rouen
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Saint Cloud Cedex
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Toulon
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Israel
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Israel
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Israel
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Haifa
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Israel
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Kfar saba
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Israel
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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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Poland
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Krakow
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Poland
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Lodz
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Poland
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Warsaw
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Poland
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Warszawa
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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A coruna
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Spain
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Alcorcon
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Spain
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Barcelona
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Spain
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El palmar
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Jerez de la frontera
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Leon
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Madrid
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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
Country [123] 0 0
Spain
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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
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.
Trial website
https://clinicaltrials.gov/study/NCT01122472
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.
Public notes

Contacts
Principal investigator
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Address 0 0
Country 0 0
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Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01122472