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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionLymphoma
Diffuse Large B-cell Lymphoma
InterventionDrug: Lenalidomide
Drug: Placebo
PhasePhase 3
SponsorThe Lymphoma Academic Research Organisation
Responsible PartyThe Lymphoma Academic Research Organisation
ClinicalTrials.gov IdentifierNCT01122472
First ReceivedApril 8, 2010
Last UpdatedJanuary 23, 2013
Last verifiedJanuary 2013

Tracking Information[ + expand ][ + ]

First Received DateApril 8, 2010
Last Updated DateJanuary 23, 2013
Start DateApril 2009
Estimated Primary Completion DateAugust 2017
Current Primary Outcome MeasuresProgression-Free-Survival (PFS) [Time Frame: Final PFS analysis will be realized when the number of events (282) 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.] [Designated as safety issue: No]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.
Current Secondary Outcome Measures
  • Overall survival (OS) [Time Frame: Approximate schedule to reach 278 deaths will be 78 months after the first patient has been randomized.] [Designated as safety issue: No]OS will be set when 278 deaths have been observed or at least when the number of events for PFS (282) has been reached or at the latest when the last patient into the study will finish follow up. OS is from the date of randomization to the date of death from any cause
  • Event-Free Survival (EFS) [Time Frame: Approximate schedule will be 78 months after the first patient has been randomized.] [Designated as safety issue: No]EFS is from the date of randomization to the date of first documented disease progression or initiation of new anti-lymphoma therapy or death from any cause.
  • Response rate at the end of maintenance treatment [Time Frame: From randomization to the end of the 24 months maintenance] [Designated as safety issue: No]
  • Percentage of patients who convert from PR (partial response) to CR (complete response) [Time Frame: From randomization to the end of maintenance treatment. Average of 74 months] [Designated as safety issue: No]
  • Safety of lenalidomide in maintenance [Time Frame: From randomization of the first patient to 3 years after the randomization of the last patient] [Designated as safety issue: Yes]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

Descriptive Information[ + expand ][ + ]

Brief TitleStudy of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP
Official TitleDouble Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line
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.
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition
  • Lymphoma
  • Diffuse Large B-cell Lymphoma
InterventionDrug: Lenalidomide
Daily for 3 weeks every 4 weeks for 24 months
Other Names:
RevlimidDrug: Placebo
Daily for 3 weeks every 4 weeks for 24 months
Study Arm (s)
  • 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

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment621
Estimated Completion DateAugust 2017
Estimated Primary Completion DateAugust 2017
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
GenderBoth
Ages60 Years
Accepts Healthy VolunteersNo
ContactsContact: Bertrand COIFFIER, Prof
33 4 78 86 43 01
bertrand.coiffier@chu-lyon.fr
Location CountriesAustralia, Austria, Belgium, France, Israel, Poland, Portugal, Spain, Switzerland

Administrative Information[ + expand ][ + ]

NCT Number NCT01122472
Other Study ID NumbersREMARC
Has Data Monitoring CommitteeNo
Information Provided ByThe Lymphoma Academic Research Organisation
Study SponsorThe Lymphoma Academic Research Organisation
CollaboratorsNot Provided
Investigators Principal Investigator: Bertrand COIFFIER, Prof Lymphoma Study Association
Verification DateJanuary 2013

Locations[ + expand ][ + ]

Flinders Medical Centre - Repatriation General Hospital
Adelaïde south australia, Australia, 5000
Contact: David ROSS, Dr | David.Ross@health.sa.gov.au
Principal Investigator: David ROSS, Dr
Not yet recruiting
Bendigo Hospital
Bendigo, Australia, 3550
Contact: Robert BLUM, Dr | 0061354548815 | Robert.Blum@bendigohealth.org.au
Principal Investigator: Robert BLUM, Dr
Not yet recruiting
Concord Repatriation General Hospital
Concord - nsw, Australia, 2139
Contact: Judith TROTMAN, Dr | 0061297675757 | judith.trotman@sswahs.nsw.gov.au
Principal Investigator: Judith TROTMAN, Dr
Recruiting
St Vincent's Hospital, Melbourne
Fitzroy, Australia, 3065
Contact: Constantine TAM, Dr | 0061392884051 | constantine.tam@svhm.org.au
Principal Investigator: Constantine TAM, Dr
Not yet recruiting
Frankston Hospital Monash Medical Centre
Frankston, Australia, 3199
Contact: John CATALANO, Dr | 0061397848283 | john.catalano@med.monash.edu.au
Principal Investigator: John CATALANO, Dr
Recruiting
Fremantle Hospital
Fremantle - WA, Australia, 6160
Contact: Michael LEAHY, Dr | 0061894312886 | michael.leahy@health.wa.gov.au
Principal Investigator: Michael LEAHY, Dr
Not yet recruiting
Austin Hospital
Heidelberg, Australia, 69126
Contact: Geoff CHONG, Dr
Principal Investigator: Geoff CHONG, Dr
Not yet recruiting
Royal Hobart Hospital
Hobart, Australia, 7000
Contact: Roger KIMBER, Dr | 0061362228308 | roger.kimber@dhhs.tas.gov.au
Principal Investigator: Roger KIMBER, Dr
Not yet recruiting
Mater Misericordiae Hospital - Calvary Mater NewCastle
Hunter, Australia, 2310
Contact: Sandra DEVERIDGE, Dr
Principal Investigator: Sandra DEVERIDGE, Dr
Not yet recruiting
St George Hospital
Kogarah, Australia, 2217
Contact: Sundra RAMANATHAN, Dr | 0061293503141 | mh@harv.net.au
Principal Investigator: Sundra RAMANATHAN, Dr
Recruiting
Sir Charles Gardiner Hospital
Nedlands - WA, Australia, 6009
Contact: David J.L. JOSKE, Dr | 0061893467600 | david.joske@health.wa.gov.au
Principal Investigator: David J.L. JOSKE, Dr
Not yet recruiting
Gold Coast Hospital
Southport, Australia, 4215
Contact: Tara SESHADRI, Dr | Tara_Seshadri@health.gld.gov.au
Principal Investigator: Tara SESHADRI, Dr
Not yet recruiting
Canberra Hospital
Woden - ACT, Australia, 2606
Contact: James D'ROZARIO, Dr | 0061262442830
Principal Investigator: James D'ROZARIO, Dr
Not yet recruiting
Albury Base Hospital/Murray Valley Private Hospital
Wodonga, Australia, 3690
Contact: Christopher STEER, Dr | 0061260553200
Principal Investigator: Christopher STEER, Dr
Not yet recruiting
Queen Elizabeth Hospital
Woodville -sa, Australia, 5011
Contact: Uwe HAHN, Dr | 0061882226934 | uwe.hahn@imvs.sa.gov.au
Principal Investigator: Uwe HAHN, Dr
Not yet recruiting
LKH Feldkirch
Feldkirch, Austria, 6807
Contact: Alois LANG, Dr | 004355223032300 | alois.lang@lkhf.at
Principal Investigator: Alois FRIDRIK, Dr
Not yet recruiting
Medizinische Universität Innsbruck für Innere Medizin
Innsbruck, Austria, 6020
Contact: Wolfgang WILLENBACHER, Dr | 004351250482057 | wolfgang.willenbacher@uki.at
Principal Investigator: Wolfgang WILLENBACHER, Dr
Not yet recruiting
LKH Leoben-Eisenerz Department für Hämato-Onkologie
Leoben, Austria, 8700
Contact: Felix KEIL, Pr | 004338424012821 | felix.keil@lkh-leoben.at
Principal Investigator: Felix KEIL, Pr
Not yet recruiting
Krankenhaus Barmherzigen Schwestern Linz - Abteilung für Inner
Linz, Austria, 4010
Contact: Andreas PETZER, Pr | 004373276777345 | andreas.petzer@bhs.at
Principal Investigator: Andreas PETZER, Pr
Not yet recruiting
AKh Linz - Innere Medizin 3 - Zentrum für Hämatologie un
Linz, Austria, 4021
Contact: Michael FRIDRIK, Dr | 004373278061610 | michael.fridrik@akh.linz.at
Principal Investigator: Michael FRIDRIK, Dr
Not yet recruiting
Krankenhaus der Elisabethinen Linz GmbH
Linz, Austria, 4010
Contact: Michael GIRSCHIKOFSKY, Dr | michael.girschikofsky@elisabethinen.or.at
Principal Investigator: Michael GIRSCHIKOFSKY, Dr
Recruiting
Universitätklinik der PMU Salzburg - Für Innere Medizin III
Salzburg, Austria, 5020
Contact: Richard GREIL, Pr | 004366244822847 | r.greil@salk.at
Principal Investigator: Richard GREIL, Pr
Recruiting
Landeskrankenhaus Steyr - Innere Medizin II
Steyr, Austria, 4400
Contact: Johannes ANDEL, Dr | johannes.andel@gespag.at
Principal Investigator: Johannes ANDEL, Dr
Not yet recruiting
Uniersitätsklinik f. Innere Medizin I
Vienna, Austria, A-1090 VIE
Contact: Ulrich JAGER, Dr | 00043144409 | ulrich.jaeger@meduniwien.ac.at
Principal Investigator: Ulrich JAGER, Dr
Not yet recruiting
Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Contact: Josef THALER, Dr | 0043724241593450 | josef.thaler@klinikum-wels.at
Principal Investigator: Josef THALER, Dr
Not yet recruiting
ZNA Middelheim
Antwerpen, Belgium, 2020
Contact: Hadewijch DE SAMBLANX, Pharm. | 003232804030 | De.Samblanx.H@telenet.be
Principal Investigator: Hadewijch DE SAMBLANX, Pharm.
Not yet recruiting
ZNA Stuivenberg
Antwerpen, Belgium, 2060
Contact: Pierre ZACHEE, Dr | 003232177655 | pierre.zachee@zna.be
Principal Investigator: Pierre ZACHEE, Dr
Recruiting
Hopital Saint Joseph
Arlon, Belgium, 6700
Contact: Pascal PIERRE, Dr | 003263231383 | ppierre@clinsudlux.be
Principal Investigator: Pascal PIERRE, Dr
Recruiting
A.Z. Sint Jan AV
Bruges, Belgium, 8000
Contact: Achiel VAN HOOF, Dr | 003250452627 | achiel.vanhoof@azbrugge.be
Principal Investigator: Achiel VAN HOOF, Dr
Recruiting
CHU Brugmann
Bruxelles, Belgium, 1020
Contact: Andre EFIRA, Dr | 003224772111 | andre.efira@chu-brugmann.be
Principal Investigator: Andre EFIRA, Dr
Not yet recruiting
Universite Catholique de Louvain Saint Luc
Bruxelles, Belgium
Contact: Eric VAN DEN NESTE, Dr | 003227641800 | vandenneste@uclouvain.be
Principal Investigator: Eric VAN DER NESTE, Dr
Recruiting
Institut Jules BORDET
Bruxelles, Belgium
Contact: Dominique BRON, Dr | 003225413212 | dominique.bron@bordet.be
Principal Investigator: Dominique BRON, Dr
Not yet recruiting
CH Notre Dame
Charleroi, Belgium, 6000
Contact: Marc ANDRE, Dr | 003271281666 | andre@onco.ucl.ac.be
Principal Investigator: Marc ANDRE, Dr
Recruiting
CHU Charleroi-Vesale
Charleroi, Belgium, B-6000
Contact: Agnes TRIFFET, Dr | 003271921100
Principal Investigator: Agnes TRIFFET, Dr
Not yet recruiting
Centre de Sante des Fagnes
Chimay, Belgium, 6460
Contact: Oussama HAMDAN, Dr | 003260218811 | dr.o.hamdan@csf.be
Principal Investigator: Oussama HAMDAN, Dr
Recruiting
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Contact: Fritz OFFNER, Dr | 003292402138 | fritz.offner@ugent.be
Principal Investigator: Fritz OFFNER, Dr
Recruiting
Clinique Notre Dame de Grace
Gosselies, Belgium, 6041
Contact: Marie MAEREVOET, Dr | 003271379562 | marie.maerevoet@yahoo.fr
Principal Investigator: Marie MAEREVOET, Dr
Recruiting
Hopital Jolimont
Haine saint paul, Belgium, 7100
Contact: Nicole STRAETMANS, Dr | 003264233989 | nicole.straetmans@entitejolimontoise.be
Principal Investigator: Nicole STRAETMANS, Dr
Recruiting
CH Hutois
HUY, Belgium, 4500
Contact: Caroline JACQUY, Dr | 0032 85 27 21 11 | caroline.jacquy@chh.be
Principal Investigator: Caroline JACQUY, Dr
Not yet recruiting
AZ VUB
Jette, Belgium, 1090
Contact: Fabienne TRULLEMANS, Dr | 003224776211 | Fabienne.Trullemans@uzbrussel.be
Principal Investigator: Fabienne TRULLEMANS, Dr
Not yet recruiting
AZ Groeninge - Campus Maria s Voorzienigheid
Kortrijk, Belgium, 8500
Contact: Koenraad VAN EYGEN, Dr | 003256234507 | koen.vaneygen@azgroeninge.be
Principal Investigator: Koenraad VAN EYGEN, Dr
Recruiting
CHR de la Citadelle
Liege, Belgium, 4000
Contact: Steven VAN STEENWEGHEN, Dr | 003243668256 | steven.vansteenweghen@chrcitadelle.be
Principal Investigator: Steven VAN STEENWEGHEN, Dr
Not yet recruiting
CHU de Liege
Liege, Belgium, 4000
Contact: Christophe BONNET, Dr | 003243667111 | cbonnet@ulg.ac.be
Principal Investigator: Christophe BONNET, Dr
Recruiting
CHU Ambroise Pare
Mons, Belgium, 7000
Contact: Valérie ROBIN, Dr | 003265393744 | valrie.robin@hap.be
Principal Investigator: Valerie ROBIN, Dr
Recruiting
Clinique Saint Joseph
Mons, Belgium, 7000
Contact: Dominique BOULET, Dr | 003265359170 | dominique.boulet@chr-afic.be
Principal Investigator: Dominique BOULET, Dr
Not yet recruiting
Hopital Sainte Elisabeth
Namur, Belgium, 5000
Contact: Valerie MATHIEUX, Dr | 003281720547 | vmathieux@ohr.be
Principal Investigator: Valerie MATHIEUX, Dr
Not yet recruiting
Clinique Saint Pierre
Ottignies, Belgium, 1340
Contact: Thierry CONNEROTTE, Dr | 003210437241 | thierry.connerotte@uclouvain.be
Principal Investigator: Thierry CONNEROTTE, Dr
Not yet recruiting
Heilig Hart Ziekenhuis
Roeselare, Belgium, 8800
Contact: DEMUYNCK Hilde, Dr | 003251237251 | HDemuynck@hhr.be
Principal Investigator: Hilde DEMUYNCK, Dr
Not yet recruiting
CH de la Tourelle-Peltzer
Verviers, Belgium, 4800
Contact: Gaetan VANSTRAELEN, Dr | 003287212171 | gaetan.vanstraelen@chplt.be
Principal Investigator: Gaetan VANSTRAELEN, Dr
Not yet recruiting
A.Z. Sint-Augustinus
Wilrijk, Belgium, 2610
Contact: Jan LEMMENS, Dr | 003234433737 | jan.lemmens@gza.be
Principal Investigator: Jan LEMMENS, Dr
Recruiting
Universite Catholique de Louvain Mont Godinne
Yvoir, Belgium, 5530
Contact: Andre BOSLY, Dr | 003281423840 | andre.bosly@uclouvain.be
Principal Investigator: Andre BOSLY, Dr
Recruiting
CHR de la Région d'Annecy
Annecy Cedex, France, 74011
Contact: Bernadette CORRONT, Dr | 0450636608 | bcorront@ch-annecy.fr
Principal Investigator: Bernadette CORRONT, Dr
Recruiting
CH Antibes-Juan les Pins
Antibes, France, 06606
Active, not recruiting
CH d'Arras
Arras Cedex, France, 62022
Contact: Pauline LIONNE HUYGHE, Dr | 0321211390 | Pauline.LIONNE-HUYGHE@ch-arras.fr
Principal Investigator: Pauline LIONNE HUYGHE, Dr
Recruiting
Hopital Henri DUFFAUT
Avignon, France, 84902
Contact: Hacène ZERAZHI, Dr | 0432753251 | hzerazhi@ch-avignon.fr
Principal Investigator: Hacène ZERAZHI, Dr
Recruiting
Hopital de BAYONNE
Bayonne, France, 64100
Contact: Frederic BAUDUER, Dr | 0559443841 | fbauduer001@ch-cotebasque.fr
Principal Investigator: Frederic BAUDUER, Dr
Recruiting
CHG Mail Pierre Charlot
Blois, France, 41016
Contact: Abderrazak EL YAMANI, Pr | 0254556504 | elyamaa@ch-blois.fr
Principal Investigator: Abderrazak EL YAMANI, Dr
Recruiting
Hôpital d'Avicenne
Bobigny, France, 93009
Contact: Sophie CEREJA, Dr | 0148957071 | sophie.cereja@avc.aphp.fr
Principal Investigator: Sophie CEREJA, Dr
Recruiting
Hopital Jean VERDIER
BONDY Cedex, France, 93143
Contact: Olivier FAIN, Dr | 0148026380 | olivier.fain@jvr.ap-hop-paris.fr
Principal Investigator: Olivier FAIN, Dr
Not yet recruiting
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Contact: Olivier FITOUSSI, Dr | 0556437354 | o.fitoussi@bordeauxnord.com
Principal Investigator: Olivier FITOUSSI, Dr
Recruiting
Hopital DUCHENNE
Boulogne sur Mer, France, 62200
Contact: Bachra CHOUFI, Dr | 0321993732 | b.choufi@ch-boulogne.fr
Principal Investigator: Bachra CHOUFI, Dr
Recruiting
CH de Bourg-en-Bresse
Bourg-en-Bresse, France, 01012
Contact: Hubert ORFEUVRE, Dr | 0474454648 | horfeuvre@ch-bourg01.fr
Principal Investigator: Hubert ORFEUVRE, Dr
Recruiting
Centre Hospitalier de Brive
Brive-La-Gaillarde, France, 19100
Active, not recruiting
CHU Clémenceau- Côte de Nacre
Caen Cedex, France, 14033
Contact: Margaret MACRO, Dr | 0231272633 | macro-m@chu-caen.fr
Principal Investigator: Margaret MACRO, Dr
Recruiting
Centre François Baclesse
CAEN Cedex 05, France, 14026
Contact: Christophe FRUCHART, Dr | 0231455029 | c.fruchart@baclesse.fr
Principal Investigator: Christophe FRUCHART, Dr
Recruiting
CH de Cannes
Cannes, France, 06400
Active, not recruiting
Hôpital de Châlon
Chalon sur Saone, France, 711100
Contact: Bruno SALLES, Dr | 0385446698 | bruno.salles@ch-chalon71.fr
Principal Investigator: Bruno SALLES, Dr
Not yet recruiting
Centre Hospitalier
Chambery, France, 73011
Active, not recruiting
CH Chartres
Chartres Cedex, France, 28018 BP407
Contact: Lina ALJASSEM, Dr | 0237303077 | aljassem@ch-chartres.fr
Principal Investigator: Lina AL JASSEM, Dr
Recruiting
Hôpital des instructions des Armées PERCY
Clamart, France, 92140
Contact: Bertrand SOULEAU, Dr | 0141466306 | bertrand.souleau@wanadoo.fr
Principal Investigator: Bertrand SOULEAU, Dr
Not yet recruiting
Hopital Antoine Béclère
Clamart, France, 92140
Active, not recruiting
Hopital Louis Pasteur
Colmar Cedex, France, 68024
Contact: Bruno AUDHUY, Dr | 0389124104 | bruno.audhuy@ch-colmar.rss.fr
Principal Investigator: Bruno AUDHUY, Dr
Recruiting
CH de Compiègne
Compiegne Cedex, France, 60321
Contact: Philippe NACCACHE, Dr | 0344236347 | p.naccache002@ch-compiegne.rss.fr
Principal Investigator: Philippe NACCACHE, Dr
Not yet recruiting
Hopital Sud Francilien
Corbeil-Essonnes, France, 91108
Active, not recruiting
CH Henri Mondor
Créteil, France, 94010
Contact: Corinne HAIOUN, Pr | 0149812051 | corinne.haioun@hmn.aphp.fr
Principal Investigator: Corinne HAIOUN, Pr
Recruiting
CHU le Bocage
Dijon, France, 21034
Contact: Olivier CASASNOVAS, Dr | 02 80 29 50 47 | olivier.casasnovas@chu-dijon.fr
Principal Investigator: Olivier CASASNOVAS, Dr
Recruiting
CH de Dunkerque
Dunkerque, France, 59385
Contact: Jean Michel PIGNON | 0328285633 | Jean-Michel.Pignon@ch-dunkerque.fr
Principal Investigator: Jean-Michel PIGNON, Dr
Recruiting
CHI Evreux
Evreux, France, 27000
Terminated
CHI Fréjus Saint Raphaêl
Frejus, France, 83608
Active, not recruiting
Institut Daniel Hollard
Grenoble, France, 38028
Contact: Cécile LEYRONNAS, Dr | 0476335506 | c.leyronnas@institut-prive-cancerologie.fr
Principal Investigator: Cécile LEYRONNAS, Dr
Not yet recruiting
Centre Hospitalier de Guéret
Gueret, France, 23000
Contact: Dominique DEVESA, Dr | 0555517156
Principal Investigator: Dominique DEVESA, Dr
Recruiting
Hopital Bicêtre
Kremlin Bicêtre Cedex, France, 94275
Contact: Olivier LAMBOTTE, Dr | 0145213594 | "olivier.lambotte@bct.ap-hop-paris.fr
Principal Investigator: Olivier LAMBOTTE, Dr
Recruiting
CHG La Rochelle
La Rochelle Cedex 01, France, 17019
Contact: Emmanuel FLECK, Dr | 0546455301 | emmanuel.fleck@ch-larochelle.fr
Sub-Investigator: Emmanuel FLECK, Dr
Not yet recruiting
Hopital André Mignot
Le Chesnay, France, 78150
Contact: Hassan FARHAT, Dr | 0139638006 | hfarhat@ch-versailles.fr
Principal Investigator: Hassan FARHAT, Dr
Recruiting
Clinique Victor Hugo - Centre Jean Bernard
LE Mans, France, 72015
Contact: Philippe SOLAL CELIGNY, Dr | 0243479493 | p.solal-celigny@centre-jean-bernard.org
Principal Investigator: Philippe SOLAL-CELIGNY, Dr
Recruiting
CHU de Lens
Lens, France, 62307
Contact: Pierre MOREL, Dr | 0321691234 | pimorel@nordnet.fr
Principal Investigator: Pierre MOREL, Dr
Not yet recruiting
Hôpital Saint Vincent de Paul
Lille, France, 59020
Contact: Christian ROSE, Pr | 03 20 87 45 32 | rose.christian@ghicl.net
Principal Investigator: Christian ROSE, Pr
Not yet recruiting
CHRU de Lille
Lille Cedex, France, 59037
Contact: Franck MORSCHHAUSER, Dr | 0320445713 | f-morschhauser@chru-lille.fr
Principal Investigator: Franck MORSCHHAUSER, Dr
Recruiting
Hopital DUPUYTREN
LIMOGES Cedex, France, 87042
Contact: Dominique BORDESSOULE, Pr | 0555056642 | bordessoule.URCH@chu-limoges.fr
Principal Investigator: Dominique BORDESSOULE, Pr
Recruiting
Clinique de la Sauvegarde
Lyon, France, 69337
Contact: Isabelle MOULLET, Dr | 0437491820 | ardisson.moullet.secretariat@wanadoo.fr
Principal Investigator: Isabelle MOULLET, Dr
Recruiting
Centre Léon Bérard
LYON Cedex 08, France, 69373
Contact: Hervé GHESQUIERES, Dr | 0478782757 | GHESQUIE@lyon.fnclcc.fr
Principal Investigator: Hervé GUESQUIERES, Dr
Recruiting
CH les CHANAUX
Macon Cedex, France, 71018
Contact: Amine BELHABRI, Dr | 0385275333 | ambelhabri@ch-macon.fr
Principal Investigator: Amine BELHRABI, Dr
Recruiting
Hopital Nord
Marseille, France, 13915
Contact: Gerard SABAHOUN, Pr | 0491968802 | gsebahoun@mail.ap-hm.fr
Principal Investigator: Gérard SEBAHOUN, Dr
Not yet recruiting
Institut Paoli Calmettes
Marseille Cedex, France, 13273
Contact: Reda BOUABDALLAH, Dr | 0491223868 | bouabdallahr@marseille.fnclcc.fr
Principal Investigator: Reda BOUABDALLAH, Dr
Recruiting
CHG Meaux
Meaux, France, 77100
Active, not recruiting
CH Marc JACQUET
MELUN Cedex, France, 77011
Contact: Claire KULEKCI, Dr | 0164716442 | claire.kulekci@ch-melun.fr
Principal Investigator: Claire KULEKCI, Dr
Not yet recruiting
Hopital Notre Dame de Bon Secours
Metz Cedex, France, 57038
Contact: Bernard CHRISTIAN, Dr | 0387553304 | b.christian@chr-metz-thionville.fr
Principal Investigator: Bernard CHRISTIAN, Dr
Recruiting
Clinique du Pont de Chaume
Montauban, France, 82000
Contact: Etienne SUC, Dr | 0561579035 | esucsjl@club-internet.fr
Principal Investigator: Etienne SUC, Dr
Not yet recruiting
CRLC Val d'Aurelle
Montpellier Cedex, France, 34298
Contact: Michel FABBRO, Dr | 04676130422582 | mfabbro@valdorel.fnclcc.fr
Principal Investigator: Michel FABBRO, Dr
Recruiting
Centre Azuréen de Cancérologie
Mougins, France, 062250
Contact: Hervé NAMAN, Dr | 0492923737 | herve.naman@wanadoo.fr
Principal Investigator: Hervé NAMAN, Dt
Recruiting
Hopital Emile Muller- CHU Mulhouse
MULHOUSE Cedex, France, 68070
Contact: Jean-Claude EISENMANN, Dr | 0389647755 | eisenmannj@ch-mulhouse.fr
Principal Investigator: Jean-Claude EISENMANN, Dr
Recruiting
Hôpital Américain de Paris
Neuilly sur seine, France, 92202
Contact: Patrice CARDE, Dr | 0146412682 | p.carde@i-o-h.org
Principal Investigator: Patrice CEREJA, Dr
Recruiting
Centre Antoine Lacassagne
Nice, France, 06189
Contact: Antoine THYSS, Pr | 0492031613 | antoine.thyss@cal.nice.fnclcc.fr
Principal Investigator: Antoine THYSS, Pr
Recruiting
CHU de Nice
Nice, France, 06202
Active, not recruiting
Hopital NECKER
Paris, France, 75743
Contact: Richard DELARUE, Dr | 0144495296 | richard.delarue@nck.ap-hop-paris.fr
Principal Investigator: Richard DELARUE, Dr
Recruiting
Hopital Saint Antoine
Paris, France, 75012
Active, not recruiting
Hopital St-Louis
Paris, France, 75475
Contact: Catherine THIEBLEMONT, Dr | 0142499236 | catherine.thieblemont@sls.ap-hop-paris.fr
Principal Investigator: Catherine THIEBLEMONT, Dr
Recruiting
Hôtel Dieu
Paris Cedex 04, France, 75181
Active, not recruiting
Institut Curie
Paris Cedex 05, France, 75248
Contact: Didier DECAUDIN, Dr | 0144324690 | didier.decaudin@curie.net
Principal Investigator: Didier DECAUDIN, Dr
Not yet recruiting
Hopital de la Pitié Salpetrière
Paris Cedex 13, France, 75651
Contact: Jean GABARRE, Dr | 0142162791 | jean.gabarre@psl.aphp.fr
Principal Investigator: Jean GABARRE, Dr
Recruiting
CH de Perpignan
Perpignan, France, 66046
Contact: Laurence SAHNES, Dr | 0468616448 | laurence.sanhes@ch-perpignan.fr
Principal Investigator: Laurence SANHES, Dr
Recruiting
Centre Hospitalier Lyon Sud
Pierre Bénite Cedex, France, 64495
Contact: Bertrand COIFFIER, Pr | 0478864301 | bertrand.coiffier@chu-lyon.fr
Principal Investigator: Bertrand COIFFIER, Pr
Recruiting
CH René DUBOS
Pontoise, France, 95303
Contact: Hugo GONZALEZ, Dr | 0130754928 | hugo.gonzalez@ch-pontoise.fr
Principal Investigator: Hugo GONZALEZ, Dr
Recruiting
Hopital Robert DEBRE
REIMS Cedex, France, 51092
Contact: Alain DELMER, Dr | 0326783644 | adelmer@chu-reims.fr
Principal Investigator: Alain DELMER, Dr
Recruiting
Centre Henri BECQUEREL
Rouen, France, 76038
Contact: Hervé TILLY, Pr | 0232082223 | htilly@rouen.fnclcc.fr
Principal Investigator: Hervé TILLY, Pr
Recruiting
Clinique Mathilde
Rouen, France, 76175
Contact: Nicolas ALBIN, Dr | 0232811089 | n.albin@wanadoo.fr
Principal Investigator: Nicolas ALBIN, Dr
Recruiting
Centre René Huguenin
Saint Cloud Cedex, France, 92211
Contact: Carole SOUSSAIN, Dr | 0147111536 | soussain@crh1.org
Principal Investigator: Carole SOUSSAIN, Dr
Recruiting
CHG Saint Germain
St Germain en Laye, France, 78105
Terminated
CHI Toulon La Seyne-sur-mer
Toulon, France, 83056
Contact: Claudine SOHN, Dr | 0494230443 | claudine.sohn@ch-toulon.fr
Principal Investigator: Claudine SOHN, Dr
Recruiting
CHU Purpan Pav. Dieulafoy
Toulouse Cedex 9, France, 31059
Terminated
Hopital de Troyes
Troyes Cedex, France, 10000
Contact: Nadia ALI-AMMAR, Dr | 0325494721 | nadia.ali-amar@ch-troyes.fr
Principal Investigator: Nadia ALI AMMAR, Dr
Recruiting
CH Valence
Valence Cedex 9, France, 26953
Contact: Bruno ANGLARET, Dr | 0475757569 | bruno.anglaret@ch-valence.fr
Principal Investigator: Bruno ANGLARET, Dr
Recruiting
CH de Valenciennes
Valenciennes, France, 59322
Contact: Marc SIMON, Dr | 0327143607 | simon-m@ch-valenciennes.fr
Principal Investigator: Marc SIMON, Dr
Recruiting
CHU Nancy Brabois
Vandoeuvre, France, 54511
Contact: Serge BOLOGNA, Dr | 0383153282 | s.bologna@chu-nancy.fr
Principal Investigator: Serge BOLOGNA, Dr
Recruiting
Institut Gustave ROUSSY
VILLEJUIF Cedex, France, 94805
Contact: Christophe FERME, Dr | 01421142114238 | christophe.ferme@igr.fr
Principal Investigator: Christophe FERME, Dr
Recruiting
Haemek Medical Center
Afula, Israel, 18101
Contact: Michael BENET, Dr | 04-6495437 | benet_m@clalit.org.il
Principal Investigator: Michael BENET, Dr
Not yet recruiting
Barzilai Medical Center
Ashkelon, Israel, 78278
Contact: Gil LUGASSY, Pr | 08-6745795 | brzgil@barzi.health.gov.il
Principal Investigator: Gil LUGASSY, Pr
Not yet recruiting
Soroka
Beer sheva, Israel, 84101
Contact: Itai LEVI, Dr | 08-6403779 | etail@clalit.org.il
Principal Investigator: Itai LEVI, Dr
Not yet recruiting
Bnai-Zion medical center
Haifa, Israel, 31048
Contact: Dina ATTIAS, Dr | 04-8359407 | a.attias@b-zion.org.il
Principal Investigator: Dina ATTIAS, Dr
Not yet recruiting
Meir Medical Center
Kfar saba, Israel, 44281
Contact: Maya BERLA, Dr | 09-7472786 | Maya.Berla@clalit.org.il
Principal Investigator: Maya BERLA, Dr
Not yet recruiting
Rabin Medical Center - Beilinson Hospital
Petah Tikwah, Israel, 49100
Contact: Amos COHEN, Pr | 972-523683547 | amosC@clalit.org.il
Principal Investigator: Amos COHEN, Pr
Not yet recruiting
Kaplan Medical Center
Rehovot, Israel, 76100
Contact: Lev SHVIDEL, Dr | 08-9441383 | LeSh@clalit.org.il
Principal Investigator: Lev SHVIDEL, Dr
Not yet recruiting
SPZOZ Zespol Szpitali Miejskich w Chorzowie
Chorzow, Poland, 41500
Contact: Sebastian GROSICKI, Dr | 0048600388282 | sgrosicki@wp.pl
Principal Investigator: Sebastian GROSICKI, Dr
Not yet recruiting
Klinika Hematologii Collegium Medicum UJ
Krakow, Poland, 31501
Contact: Aleksander SKOTNICKI, Pr | alekskot@cm-uj.krakow.pl
Principal Investigator: Aleksander SKOTNICKI, Pr
Not yet recruiting
Oddzial Chorob Rozrostowych Regionalny Osrodek Onkologiczny
Lodz, Poland, 93509
Contact: Ewa KALINKA-WARZOCHA, Dr | 0048426895471 | ewa_kalinka@op.pl
Principal Investigator: Ewa KALINKA-WARZOCHA, Dr
Not yet recruiting
Medical University of Warsaw
Warsaw, Poland, 02776
Contact: Krzysztof WARZOCHA, Pr | 0048223496176 | warzocha@ihit.waw.pl
Principal Investigator: Krzysztof WARZOCHA, Pr
Not yet recruiting
Klinika Nowotworow Ukladu Chlonnego- Centrum Onkologii
Warszawa, Poland, 02781
Contact: Jan WALEWSKI, Pr | 0048225462223 | walewski@coi.waw.pl
Principal Investigator: Jan WALEWSKI, Pr
Not yet recruiting
Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000 - 075
Contact: Catarina GERALDES, Dr | 00351938406984 | catarinageraldes08@gmail.com
Principal Investigator: Catarina GERALDES, Dr
Not yet recruiting
Instituto Português de Oncologia de Lisboa de Francisco Gentil
Lisboa, Portugal, 1099 - 023
Contact: Maria GOMES DA SILVA, Pr | 00351217229867 | mgsilva@ipolisboa.min-saude.pt
Principal Investigator: Maria GOMES DA SILVA, Pr
Recruiting
Hospital de Santa Maria
Lisboa, Portugal, 1649 - 035
Contact: Joao RAPOSO, Dr | jraposo@netcabo.pt
Principal Investigator: Joao RAPOSO, Dr
Not yet recruiting
IPO - Francisco Gentil - Porto
Porto, Portugal, 4200
Contact: Mario MARIZ, Dr | 00351961760872 | jmmariz@yahoo.com
Principal Investigator: Mario MARIZ, Dr
Not yet recruiting
Complejo Hospitalario Universitario de A Coruna
A coruna, Spain, 15006
Contact: Juan Pio TORRES CARRETE, Dr | 0034981178055 | j.p.torres@canalejo.org
Principal Investigator: Juan Pio TORRES CARRETE, Dr
Not yet recruiting
Hospital Universitario Fundacion Alcorcon
Alcorcon, Spain, 28922
Contact: Lucia VILLALON, Dr | 0034916219896 | lvillalon@fhalcorcon.es
Principal Investigator: Lucia VILLALON, Dr
Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Contact: Javier BRIONES, Dr | 0034935565649 | jbriones@hsp.santpau.es
Principal Investigator: Javier BRIONES, Dr
Recruiting
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Contact: Armando LOPEZ GUILLERMO, Dr | 0034932275575 | alopezg@clinic.ub.es
Principal Investigator: Armando LOPEZ GUILLERMO, Dr
Recruiting
Hopital Universitario Virgen de la Arrixaca
El palmar, Spain, 30120
Contact: José Maria MORALEDA JIMENEZ, Dr | 0034968369532 | jmoraled@um.es
Principal Investigator: José Maria MORALEDA JIMENEZ, Dr
Recruiting
Hopital de Jerez (S.A.S)
Jerez de la frontera, Spain, 11407
Contact: Maria José RAMIREZ SANCHEZ, Dr | 0034956032055 | mariajoserasa@yahoo.es
Principal Investigator: Maria José RAMIREZ SANCHEZ, Dr
Not yet recruiting
Hospital de Leon
Leon, Spain, 24080
Contact: Silvia FERNANDEZ FERRERO, Dr | 0034987222312 | silviafe@yahoo.com
Principal Investigator: Silvia FERNANDEZ FERRERO, Dr
Not yet recruiting
Hospital Général Universitario Gregorio Maranon
Madrid, Spain, 28007
Contact: Jorge GAYOSO CRUZ, Dr | 0034915868394 | jgayoso.hgugm@salud.madrid.org
Principal Investigator: Jorge GAYOSO GARCIA, Dr
Not yet recruiting
Hospital 12 de Octubre
Madrid, Spain, 28003
Contact: Carlos GRANDE GARCIA, Dr | 0034913908570 | cgrande.hdoc@salud.madrid.org
Principal Investigator: Carlos GRANDE GARCIA, Dr
Recruiting
Hospital Universitario - La Paz
Madrid, Spain, 28046
Contact: Miguel CANALES ALBENDEA, Dr | 0034917277116 | mcanales.hulp@salud.madrid.org
Principal Investigator: Miguel CANALES ALBENDEA, Dr
Recruiting
Hospital Morales Meseguer
Murcia, Spain, 30008
Contact: Elena PEREZ CEBALLO, Dr | 0034968360969 | elena.perez@carm.es
Principal Investigator: Elena PEREZ CEBALLO, Dr
Not yet recruiting
Hospital Central Asturias
Oviedo, Spain, 33006
Contact: Concepcion NICOLAS GARCIA, Dr | 00034985108000 | conchanicolas61@gmail.com
Principal Investigator: Concepcion NICOLAS GARCIA, Dr
Recruiting
Hospital Clinico Salamanca
Salamanca, Spain, 37007
Contact: Dolores CABALLERO-BARRIGON, Dr | 0034923291316 | cabarri@usal.es
Principal Investigator: Dolores CABALLERO-BARRIGON, Dr
Recruiting
Universitario Marques de Valdecilla
Santander, Spain, 39008
Contact: Eulogio CONDE GARCIA, Dr | +34 942 203 450 | hemcge@humv.es
Principal Investigator: Eulogio CONDE GARCIA, Dr
Not yet recruiting
Hospital Joan XXIII
Tarragona, Spain, 43007
Contact: Lourdes ESCODA, Dr | 0034977295880 | lescoda.hj23.ics@gencat.cat
Principal Investigator: Lourdes ESCODA, Dr
Recruiting
Hospital Mutua de Terrassa
Terrassa, Spain, 08221
Contact: Anna MUNTANYOLA, Dr | amuntanola@mutuaterrassa.es
Principal Investigator: Anna MUNTANYOLA, Dr
Not yet recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Contact: Nicolas KETTERER, Dr | 0041233140166 | nicolas.ketterer@chuv.hospvd.ch
Principal Investigator: Nicolas KETTERER, Dr
Recruiting