search
Back to results

Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP (REMARC)

Primary Purpose

Lymphoma, Diffuse Large B-cell Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Lenalidomide
Placebo
Sponsored by
The Lymphoma Academic Research Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring lenalidomide (Revlimid), diffuse large B-cell lymphoma, phase III study, after R-CHOP, Maintenance treatment, Maintenance

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Ages Eligible for Study: Between 60 and 80 years old

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Inclusion Criteria:

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

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

Sites / Locations

  • Bendigo Hospital
  • Concord Repatriation General Hospital
  • Flinders Medical Centre - Repatriation General Hospital
  • St Vincent's Hospital, Melbourne
  • Frankston Hospital Monash Medical Centre
  • Fremantle Hospital
  • Canberra Hospital
  • Austin Hospital
  • Royal Hobart Hospital
  • Mater Misericordiae Hospital - Calvary Mater NewCastle
  • St George Hospital
  • Sir Charles Gardiner Hospital
  • Gold Coast Hospital
  • Albury Base Hospital/Murray Valley Private Hospital
  • Queen Elizabeth Hospital
  • LKH Feldkirch
  • Medizinische Universität Innsbruck für Innere Medizin
  • LKH Leoben-Eisenerz Department für Hämato-Onkologie
  • Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner
  • Krankenhaus der Elisabethinen Linz GmbH
  • AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un
  • Universitätklinik der PMU Salzburg - Für Innere Medizin III
  • Landeskrankenhaus Steyr - Innere Medizin II
  • Uniersitätsklinik f. Innere Medizin I
  • Klinikum Wels-Grieskirchen GmbH
  • ZNA Middelheim
  • ZNA Stuivenberg
  • Hopital Saint Joseph
  • A.Z. Sint Jan AV
  • CHU Brugmann
  • Institut Jules BORDET
  • Universite Catholique de Louvain Saint Luc
  • CH Notre Dame
  • CHU Charleroi-Vesale
  • Centre de Sante des Fagnes
  • Universitair Ziekenhuis Gent
  • Clinique Notre Dame de Grace
  • Hopital Jolimont
  • CH Hutois
  • AZ VUB
  • AZ Groeninge - Campus Maria s Voorzienigheid
  • CHR de la Citadelle
  • CHU de Liege
  • CHU Ambroise Pare
  • Clinique Saint Joseph
  • Hopital Sainte Elisabeth
  • Clinique Saint Pierre
  • Heilig Hart Ziekenhuis
  • CH de la Tourelle-Peltzer
  • A.Z. Sint-Augustinus
  • Universite Catholique de Louvain Mont Godinne
  • CHR de la Région d'Annecy
  • CH Antibes-Juan les Pins
  • CH d'Arras
  • Hopital Henri DUFFAUT
  • Hopital de BAYONNE
  • CHG Mail Pierre Charlot
  • Hôpital d'Avicenne
  • Hopital Jean VERDIER
  • Polyclinique Bordeaux Nord Aquitaine
  • Hopital DUCHENNE
  • CH de Bourg-en-Bresse
  • Centre Hospitalier de Brive
  • Centre François Baclesse
  • CHU Clémenceau- Côte de Nacre
  • CH de Cannes
  • Hôpital de Châlon
  • Centre Hospitalier
  • CH Chartres
  • Hopital Antoine Béclère
  • Hôpital des instructions des Armées PERCY
  • Hopital Louis Pasteur
  • CH de Compiègne
  • Hopital Sud Francilien
  • CH Henri Mondor
  • CHU le Bocage
  • CH de Dunkerque
  • CHI Evreux
  • CHI Fréjus Saint Raphaêl
  • Institut Daniel Hollard
  • Centre Hospitalier de Guéret
  • CHG La Rochelle
  • Hopital André Mignot
  • Hopital Bicêtre
  • Clinique Victor Hugo - Centre Jean Bernard
  • CHU de Lens
  • CHRU de Lille
  • Hôpital Saint Vincent de Paul
  • Hopital DUPUYTREN
  • Centre Léon Bérard
  • Clinique de la Sauvegarde
  • CH les CHANAUX
  • Institut Paoli Calmettes
  • Hopital Nord
  • CHG Meaux
  • CH Marc JACQUET
  • Hopital Notre Dame de Bon Secours
  • CRLC Val d'Aurelle
  • Centre Azuréen de Cancérologie
  • Hopital Emile Muller- CHU Mulhouse
  • Hôpital Américain de Paris
  • Centre Antoine Lacassagne
  • CHU de Nice
  • Hôtel Dieu
  • Institut Curie
  • Hopital de la Pitié Salpetrière
  • Hopital Saint Antoine
  • Hopital St-Louis
  • Hopital NECKER
  • CH de Perpignan
  • Centre Hospitalier Lyon Sud
  • CH René DUBOS
  • Hopital Robert DEBRE
  • Centre Henri BECQUEREL
  • Clinique Mathilde
  • Centre René Huguenin
  • CHG Saint Germain
  • CHI Toulon La Seyne-sur-mer
  • CHU Purpan Pav. Dieulafoy
  • Hopital de Troyes
  • CH Valence
  • CH de Valenciennes
  • CHU Nancy Brabois
  • Institut Gustave ROUSSY
  • Haemek Medical Center
  • Barzilai Medical Center
  • Soroka
  • Bnai-Zion medical center
  • Meir Medical Center
  • Rabin Medical Center - Beilinson Hospital
  • Kaplan Medical Center
  • SPZOZ Zespol Szpitali Miejskich w Chorzowie
  • Klinika Hematologii Collegium Medicum UJ
  • Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny
  • Medical University of Warsaw
  • Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii
  • Hospitais da Universidade de Coimbra
  • Instituto Português de Oncologia de Lisboa de Francisco Gentil
  • Hospital de Santa Maria
  • IPO - Francisco Gentil - Porto
  • Complejo Hospitalario Universitario de A Coruna
  • Hospital Universitario Fundacion Alcorcon
  • Hospital Clinic Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hopital Universitario Virgen de la Arrixaca
  • Hopital de Jerez (S.A.S)
  • Hospital de Leon
  • Hospital 12 de Octubre
  • Hospital Général Universitario Gregorio Maranon
  • Hospital Universitario - La Paz
  • Hospital Morales Meseguer
  • Hospital Central Asturias
  • Hospital Clinico Salamanca
  • Universitario Marques de Valdecilla
  • Hospital Joan XXIII
  • Hospital Mutua de Terrassa
  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lenalidomide

Placebo

Arm Description

Lenalidomide daily for 3 weeks every 4 weeks for 24 months

Placebo daily for 3 weeks every 4 weeks for 24 months

Outcomes

Primary Outcome Measures

Progression-Free-Survival (PFS)
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.

Secondary Outcome Measures

Overall survival (OS)
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
Event-Free Survival (EFS)
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
Response rate at the end of maintenance treatment
Percentage of patients who convert from PR (partial response) to CR (complete response)
Safety of lenalidomide in maintenance
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
PFS2
From randomization to objective tumor progression on next-line treatment or death from any cause

Full Information

First Posted
April 8, 2010
Last Updated
July 23, 2021
Sponsor
The Lymphoma Academic Research Organisation
search

1. Study Identification

Unique Protocol Identification Number
NCT01122472
Brief Title
Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP
Acronym
REMARC
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Lymphoma Academic Research Organisation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients should have received at least 6 and up to 8 cycles of the R-CHOP 14 or R-CHOP 21 regimen or 6 R-CHOP-14 or -21 completed by 2 Rituximab alone in accordance to local preferences. Patients can be registered to participate in the study at two time points: At time of initial diagnosis and study enrolment (signature of informed consent) before the first cycle of treatment with R-CHOP. At randomization (signature of informed consent) after treatment in first line with R-CHOP and have reached at least PR or CR. Evaluation of the response to R-CHOP must be in accordance with Revised Response Criteria for Malignant Lymphoma(2007). Stratification: Before randomization, the patients will be stratified according to the country and the response to R-CHOP (PR vs CR). Randomization: Patients in CR/PR after R-CHOP will be randomized to maintenance therapy with lenalidomide or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Diffuse Large B-cell Lymphoma
Keywords
lenalidomide (Revlimid), diffuse large B-cell lymphoma, phase III study, after R-CHOP, Maintenance treatment, Maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lenalidomide
Arm Type
Experimental
Arm Description
Lenalidomide daily for 3 weeks every 4 weeks for 24 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily for 3 weeks every 4 weeks for 24 months
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
Daily for 3 weeks every 4 weeks for 24 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Daily for 3 weeks every 4 weeks for 24 months
Primary Outcome Measure Information:
Title
Progression-Free-Survival (PFS)
Description
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.
Time Frame
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 Measure Information:
Title
Overall survival (OS)
Description
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
Time Frame
5 years
Title
Event-Free Survival (EFS)
Description
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
Time Frame
5 years
Title
Response rate at the end of maintenance treatment
Time Frame
24 months
Title
Percentage of patients who convert from PR (partial response) to CR (complete response)
Time Frame
24 months
Title
Safety of lenalidomide in maintenance
Description
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
Time Frame
5 years
Title
PFS2
Description
From randomization to objective tumor progression on next-line treatment or death from any cause
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Ages Eligible for Study: Between 60 and 80 years old Genders Eligible for Study: Both Accepts Healthy Volunteers: No Inclusion Criteria: 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 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
Facility Information:
Facility Name
Bendigo Hospital
City
Bendigo
ZIP/Postal Code
3550
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
ZIP/Postal Code
2139
Country
Australia
Facility Name
Flinders Medical Centre - Repatriation General Hospital
City
Daw Park
ZIP/Postal Code
5000
Country
Australia
Facility Name
St Vincent's Hospital, Melbourne
City
Fitzroy
ZIP/Postal Code
3065
Country
Australia
Facility Name
Frankston Hospital Monash Medical Centre
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Facility Name
Fremantle Hospital
City
Fremantle
ZIP/Postal Code
6160
Country
Australia
Facility Name
Canberra Hospital
City
Garran
ZIP/Postal Code
2606
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
ZIP/Postal Code
69126
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Facility Name
Mater Misericordiae Hospital - Calvary Mater NewCastle
City
Hunter
ZIP/Postal Code
2310
Country
Australia
Facility Name
St George Hospital
City
Kogarah
ZIP/Postal Code
2217
Country
Australia
Facility Name
Sir Charles Gardiner Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Facility Name
Gold Coast Hospital
City
Southport
ZIP/Postal Code
4215
Country
Australia
Facility Name
Albury Base Hospital/Murray Valley Private Hospital
City
Wodonga
ZIP/Postal Code
3690
Country
Australia
Facility Name
Queen Elizabeth Hospital
City
Woodville
ZIP/Postal Code
5011
Country
Australia
Facility Name
LKH Feldkirch
City
Feldkirch
ZIP/Postal Code
6807
Country
Austria
Facility Name
Medizinische Universität Innsbruck für Innere Medizin
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
LKH Leoben-Eisenerz Department für Hämato-Onkologie
City
Leoben
ZIP/Postal Code
8700
Country
Austria
Facility Name
Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Krankenhaus der Elisabethinen Linz GmbH
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Universitätklinik der PMU Salzburg - Für Innere Medizin III
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Landeskrankenhaus Steyr - Innere Medizin II
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Uniersitätsklinik f. Innere Medizin I
City
Vienna
ZIP/Postal Code
A-1090 VIE
Country
Austria
Facility Name
Klinikum Wels-Grieskirchen GmbH
City
Wels
ZIP/Postal Code
4600
Country
Austria
Facility Name
ZNA Middelheim
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Hopital Saint Joseph
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
A.Z. Sint Jan AV
City
Bruges
ZIP/Postal Code
8000
Country
Belgium
Facility Name
CHU Brugmann
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Institut Jules BORDET
City
Bruxelles
Country
Belgium
Facility Name
Universite Catholique de Louvain Saint Luc
City
Bruxelles
Country
Belgium
Facility Name
CH Notre Dame
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
CHU Charleroi-Vesale
City
Charleroi
ZIP/Postal Code
B-6000
Country
Belgium
Facility Name
Centre de Sante des Fagnes
City
Chimay
ZIP/Postal Code
6460
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Clinique Notre Dame de Grace
City
Gosselies
ZIP/Postal Code
6041
Country
Belgium
Facility Name
Hopital Jolimont
City
Haine saint paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CH Hutois
City
HUY
ZIP/Postal Code
4500
Country
Belgium
Facility Name
AZ VUB
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
AZ Groeninge - Campus Maria s Voorzienigheid
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU de Liege
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Ambroise Pare
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Clinique Saint Joseph
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Hopital Sainte Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Clinique Saint Pierre
City
Ottignies
ZIP/Postal Code
1340
Country
Belgium
Facility Name
Heilig Hart Ziekenhuis
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
CH de la Tourelle-Peltzer
City
Verviers
ZIP/Postal Code
4800
Country
Belgium
Facility Name
A.Z. Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Universite Catholique de Louvain Mont Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
CHR de la Région d'Annecy
City
Annecy Cedex
ZIP/Postal Code
74011
Country
France
Facility Name
CH Antibes-Juan les Pins
City
Antibes
ZIP/Postal Code
06606
Country
France
Facility Name
CH d'Arras
City
Arras Cedex
ZIP/Postal Code
62022
Country
France
Facility Name
Hopital Henri DUFFAUT
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Hopital de BAYONNE
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
CHG Mail Pierre Charlot
City
Blois
ZIP/Postal Code
41016
Country
France
Facility Name
Hôpital d'Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Hopital Jean VERDIER
City
BONDY Cedex
ZIP/Postal Code
93143
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33300
Country
France
Facility Name
Hopital DUCHENNE
City
Boulogne sur Mer
ZIP/Postal Code
62200
Country
France
Facility Name
CH de Bourg-en-Bresse
City
Bourg-en-Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
Centre Hospitalier de Brive
City
Brive-La-Gaillarde
ZIP/Postal Code
19100
Country
France
Facility Name
Centre François Baclesse
City
CAEN Cedex 05
ZIP/Postal Code
14026
Country
France
Facility Name
CHU Clémenceau- Côte de Nacre
City
Caen Cedex
ZIP/Postal Code
14033
Country
France
Facility Name
CH de Cannes
City
Cannes
ZIP/Postal Code
06400
Country
France
Facility Name
Hôpital de Châlon
City
Chalon sur Saone
ZIP/Postal Code
711100
Country
France
Facility Name
Centre Hospitalier
City
Chambery
ZIP/Postal Code
73011
Country
France
Facility Name
CH Chartres
City
Chartres Cedex
ZIP/Postal Code
28018 BP407
Country
France
Facility Name
Hopital Antoine Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital des instructions des Armées PERCY
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hopital Louis Pasteur
City
Colmar Cedex
ZIP/Postal Code
68024
Country
France
Facility Name
CH de Compiègne
City
Compiegne Cedex
ZIP/Postal Code
60321
Country
France
Facility Name
Hopital Sud Francilien
City
Corbeil-Essonnes
ZIP/Postal Code
91108
Country
France
Facility Name
CH Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU le Bocage
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
CH de Dunkerque
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
CHI Evreux
City
Evreux
ZIP/Postal Code
27000
Country
France
Facility Name
CHI Fréjus Saint Raphaêl
City
Frejus
ZIP/Postal Code
83608
Country
France
Facility Name
Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
38028
Country
France
Facility Name
Centre Hospitalier de Guéret
City
Gueret
ZIP/Postal Code
23000
Country
France
Facility Name
CHG La Rochelle
City
La Rochelle Cedex 01
ZIP/Postal Code
17019
Country
France
Facility Name
Hopital André Mignot
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Hopital Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
LE Mans
ZIP/Postal Code
72015
Country
France
Facility Name
CHU de Lens
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CHRU de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Hôpital Saint Vincent de Paul
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Hopital DUPUYTREN
City
LIMOGES Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Centre Léon Bérard
City
LYON Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Clinique de la Sauvegarde
City
Lyon
ZIP/Postal Code
69337
Country
France
Facility Name
CH les CHANAUX
City
Macon Cedex
ZIP/Postal Code
71018
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille Cedex
ZIP/Postal Code
13273
Country
France
Facility Name
Hopital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
CHG Meaux
City
Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
CH Marc JACQUET
City
MELUN Cedex
ZIP/Postal Code
77011
Country
France
Facility Name
Hopital Notre Dame de Bon Secours
City
Metz Cedex
ZIP/Postal Code
57038
Country
France
Facility Name
CRLC Val d'Aurelle
City
Montpellier Cedex
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Azuréen de Cancérologie
City
Mougins
ZIP/Postal Code
062250
Country
France
Facility Name
Hopital Emile Muller- CHU Mulhouse
City
MULHOUSE Cedex
ZIP/Postal Code
68070
Country
France
Facility Name
Hôpital Américain de Paris
City
Neuilly sur seine
ZIP/Postal Code
92202
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hôtel Dieu
City
Paris Cedex 04
ZIP/Postal Code
75181
Country
France
Facility Name
Institut Curie
City
Paris Cedex 05
ZIP/Postal Code
75248
Country
France
Facility Name
Hopital de la Pitié Salpetrière
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Hopital St-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital NECKER
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
CH de Perpignan
City
Perpignan
ZIP/Postal Code
66046
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite Cedex
ZIP/Postal Code
64495
Country
France
Facility Name
CH René DUBOS
City
Pontoise
ZIP/Postal Code
95303
Country
France
Facility Name
Hopital Robert DEBRE
City
REIMS Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Henri BECQUEREL
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Clinique Mathilde
City
Rouen
ZIP/Postal Code
76175
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud Cedex
ZIP/Postal Code
92211
Country
France
Facility Name
CHG Saint Germain
City
St Germain en Laye
ZIP/Postal Code
78105
Country
France
Facility Name
CHI Toulon La Seyne-sur-mer
City
Toulon
ZIP/Postal Code
83056
Country
France
Facility Name
CHU Purpan Pav. Dieulafoy
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Hopital de Troyes
City
Troyes Cedex
ZIP/Postal Code
10000
Country
France
Facility Name
CH Valence
City
Valence Cedex 9
ZIP/Postal Code
26953
Country
France
Facility Name
CH de Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
CHU Nancy Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave ROUSSY
City
VILLEJUIF Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Haemek Medical Center
City
Afula
ZIP/Postal Code
18101
Country
Israel
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Facility Name
Soroka
City
Beer sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Bnai-Zion medical center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Meir Medical Center
City
Kfar saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center - Beilinson Hospital
City
Petah Tikwah
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
SPZOZ Zespol Szpitali Miejskich w Chorzowie
City
Chorzow
ZIP/Postal Code
41500
Country
Poland
Facility Name
Klinika Hematologii Collegium Medicum UJ
City
Krakow
ZIP/Postal Code
31501
Country
Poland
Facility Name
Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny
City
Lodz
ZIP/Postal Code
93509
Country
Poland
Facility Name
Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02776
Country
Poland
Facility Name
Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii
City
Warszawa
ZIP/Postal Code
02781
Country
Poland
Facility Name
Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000 - 075
Country
Portugal
Facility Name
Instituto Português de Oncologia de Lisboa de Francisco Gentil
City
Lisboa
ZIP/Postal Code
1099 - 023
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
ZIP/Postal Code
1649 - 035
Country
Portugal
Facility Name
IPO - Francisco Gentil - Porto
City
Porto
ZIP/Postal Code
4200
Country
Portugal
Facility Name
Complejo Hospitalario Universitario de A Coruna
City
A coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcon
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hopital Universitario Virgen de la Arrixaca
City
El palmar
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hopital de Jerez (S.A.S)
City
Jerez de la frontera
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital de Leon
City
Leon
ZIP/Postal Code
24080
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28003
Country
Spain
Facility Name
Hospital Général Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario - La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Morales Meseguer
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Central Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Clinico Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Universitario Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Joan XXIII
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Hospital Mutua de Terrassa
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33278600
Citation
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.
Results Reference
derived
PubMed Identifier
31978225
Citation
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.
Results Reference
derived
Links:
URL
http://www.lysa-lymphoma.org/
Description
Related Info

Learn more about this trial

Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP

We'll reach out to this number within 24 hrs