search
Back to results

GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma (GAINED)

Primary Purpose

Diffuse Large B Cell Lymphoma CD20 Positive

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GA101
Rituximab
Doxorubicin
Cyclophosphamide
Prednisone
Bleomycin
Vindesin
Vincristine
Sponsored by
The Lymphoma Academic Research Organisation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B Cell Lymphoma CD20 Positive focused on measuring DLBCL, aa-IPI > or equal to 1, Diagnosis, 18 to 60 years, Lymphoma

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification)
  • Baseline PET scan available with at least one hypermetabolic lesion
  • Aged ≥ 18 years and ≤ 60 years
  • Eligible for autologous stem cell transplant
  • Patient not previously treated
  • Age adjusted International Prognostic Index (aa-IPI) equal to 1, 2 or 3
  • Life expectancy ≥ 3 months
  • Negative HIV, HBV (anti-HBc negativity) and HCV serologies before inclusion
  • Having signed a written informed consent
  • Having ability and willingness to comply with study protocol procedures
  • Men must agree to use a barrier method of contraception during the treatment period and until 3 months after the last dose of GA101 or rituximab, or ACVBP14 or CHOP14 chemotherapy, whichever is longer
  • Women of childbearing potential must agree to use an adequate method of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception during the treatment period and until 12 months after the last dose of GA101, Rituximab, ACVBP14, or CHOP14 chemotherapy, whichever is longer

Exclusion Criteria:

  • Any other histological type of lymphoma
  • Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included
  • Central nervous system or meningeal involvement by lymphoma
  • Contra-indication to any drug contained in the chemotherapy regimens
  • Poor cardiac function (LVEF < 50%) on echocardiogram or MUGA scan
  • Poor renal function (creatinine level > 150*mol/l or clearance < 30ml/min), poor hepatic function (total bilirubin level > 30µmol/l, transaminases > 2.5 X maximum normal level) unless these abnormalities are related to the lymphoma
  • Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L, unless related to bone marrow infiltration
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma
  • Any serious active disease (according to the investigator's decision)
  • Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy
  • Pregnant or lactating women
  • Adult patient under tutelage
  • Prior history of Progressive Multifocal Leukoencephalopathy (PML)

Sites / Locations

  • ZNA Stuivenberg
  • Hôpital Saint Joseph
  • RHMS Baudour
  • AZ St Jan Brugge Oostende AV
  • Institut Jules Bordet
  • CHU Brugmann
  • Hôpital Erasme
  • Clinique universitaire Saint LUC
  • CHU de Charleroi
  • Grand Hôpital de Charleroi
  • Universitair Ziekenhuis Gent
  • Ch Jolimont
  • AZ GROENINGE - Oncology Centre - Campus Maria's Voorzienigheid
  • CHR de la Citadelle
  • CHU de Liège - Clinique Saint Joseph
  • CHU de Liège -Domaine Sart Tilman
  • CHU Ambroise Paré
  • Clinique Saint Joseph -Hôpital de Warquignies
  • Clinique Sainte Elisabeth
  • Clinique Saint Pierre
  • Heilig Hart Ziekenhuis
  • Centre Hospitalier de Wallonie Picarde - CHwapi
  • CH de la Tourelle-Peltzer
  • Université Catholique de Louvain Mont Godinne
  • CH d'Abbeville
  • CHU d'Amiens - Hôpital Sud
  • CHU d'Angers
  • CH Victor Dupouy
  • CH d'Arras
  • CH d'Avignon
  • Hôpital de Bayonne - CHU de la Côte Basque
  • CH de Beauvais
  • CHU de Besançon - Hôpital Jean Minjoz
  • CH de Blois
  • APHP - Hôpital Avicenne
  • Institut Bergonié
  • Polyclinique Bordeaux Nord Aquitaine
  • CH Dr Duchenne
  • CH Fleyriat
  • CHU de Brest - Hôpital de Morvan
  • CH Brive la Gaillarde
  • CHU de Caen
  • Centre François Baclesse
  • CH de Cannes
  • Clinique Du Parc
  • CH de Chambéry
  • CHU de Châlon sur Saône
  • APHP - Hôpital Antoine Béclère
  • Hôpital d'Instruction des Armées Percy
  • CHU d'Estaing
  • Pôle Santé Publique
  • CH de Compiègne
  • CH Sud Francilien
  • APHP - Hôpital Henri Mondor
  • CHU de Dijon
  • CH de Dunkerque
  • Institut Daniel Hollard
  • CHU de Grenoble
  • CHD Vendée
  • CH La Rochelle
  • APHP - Hôpital Bicêtre
  • CH du Mans
  • Clinique Victor Hugo
  • CH de Lens
  • CH Saint Vincent de Paul
  • CHRU Lille - Hôpital Claude Huriez
  • CHU Dupruytren - Limoges
  • CH Bretagne Sud
  • Centre Léon Bérard
  • CH Mantes La Jolie
  • Hôpital de la Conception
  • Institut Paoli Calmettes
  • CH de Meaux
  • CH Marc Jacquet
  • Hôpital Notre Dame Bon Secours
  • CHI de Meulan
  • CHU de Montpellier - Saint Eloi
  • Centre Val d'Aurélie - Paul Lamarque
  • Centre Auréen de Cancérologie
  • CH de Mulhouse - Hôpital Emile Muller
  • CHU de Nantes - Hôtel Dieu
  • Centre Catherine de Sienne
  • Centre Antoine Lacassagne
  • CHU de Nice
  • CHU de Nîmes
  • Clinique Valdegour
  • CHR d'Orléans
  • APHP - Hôpital Saint Louis
  • APHP - Hôpital Saint Antoine
  • Institut Curie
  • APHP - Hôpital de la Pitié Salpetrière
  • Hôpital Cochin
  • APHP - Hôpital Necker
  • CH Saint Jean
  • CHU de Haut Lévèque
  • Hospices Civils de Lyon - CHU Lyon Sud
  • CHU de Poitiers
  • CH René Dubos
  • CH d'Annecy
  • CHU Robert Debré
  • Institut du Cancer de Courlancy
  • CHU de Rennes
  • CH de Roubaix
  • Centre Henri Becquerel
  • Clinique Mathilde
  • CH Yves Le Foll - St Brieuc
  • Centre René Huguenin
  • CHI de Poissy St Germain
  • CHU de Saint Malo
  • CH de Saint Quentin
  • Institut de Cancérologie
  • Strasbourg Oncologie Libérale
  • CHU de Strasbourg
  • Hopital Saint Husse
  • Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
  • CHU de Tours
  • CHU de Valence
  • CH de Valenciennes
  • CHU de Brabois
  • CH Bretagne Atlantique
  • CH de Versailles
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GA101

Rituximab

Arm Description

GA101 - Chemotherapy (ACVBP or CHOP)

Rituximab - Chemotherapy (ACVBP or CHOP)

Outcomes

Primary Outcome Measures

2-year Event Free Survival
EFS is defined as PET positivity according to ΔSUVmax criteria after 2 or 4 induction cycles as defined by RAC (based on central PET review), progression or relapse according to Cheson 2007, modification of planned treatment out of progression or death of any cause.

Secondary Outcome Measures

• Overall Response rate and Best overall response after 4 cycles and end of treatment according to Cheson 2007 criteria
Response will be assessed after 4 cycles and again at the end of treatment, based on RAC assessment for PET 4 and investigator assessment for EoT PET. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 2007). Overall (CR//PR) response rates and Best Response Rate will be presented. Patient without response assessment (due to whatever reason) will be considered as non-responder.
• Overall Response Rate and Best overall response after 4 cycles and end of treatment according to Cheson 1999 criteria
Response will be assessed after 4 cycles and at the end of treatment, based on investigator assessment. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999). Overall (CR/CRu/PR) response rates and Best Overall Response Rate will be presented. Patient without response assessment (due to whatever reason) will be considered as non-responder.
• Duration of response (DoR)
Duration of response is defined as the period from the time of attainment a CR or PR to the date of progression, relapse or death from any cause. Duration or response would be assessed as survival in the whole population, in the two inductive arms (R-Chemo14 vs GA101-Chemo14) For patients achieving a response but who have not progressed or relapsed or died at the time of analysis, DOR will be censored on the date of last disease assessment
• Progression-Free Survival (PFS)
Progression-Free Survival is defined as the period from the date of randomization to the date of first documented disease progression, relapse, or death from any cause. For patients who have not progressed, relapsed, or died at the time of analysis, PFS will be censored on the date of last disease assessment. If no tumor assessments were performed after the baseline visit, PFS will be censored at the time of randomization
• Overall survival (OS)
Overall survival is defined as the period from the date of randomization to the date of death from any cause. Alive patients at the time of the analysis will be censored at their last contact date
• Blood samples and on tumor tissue biopsy
Analysis on blood samples and tumor tissue biopsy will be driven, in order to explore prognosis factors of the patients and their tumors that influence treatment response based on PET assessment and prognosis
• Focus on subpopulation
Duration of response, PFS and OS will be performed according to treatment arms (R-Chemo14 vs GA101-Chemo14) on different analysis populations. The subpopulations are based on the outcome during the induction phase and a statistical bias could be introduced as subpopulations have not been defined at baseline. Population with a Δ SUVmaxPET0-2≤66% (slow and intermediate responders), Population with a Δ SUVmaxPET0-2>66% (fast responders), Patients submitted to autologous stem cell transplant (PFS and OS only)
Number of stem cell collected after GA101 treatment
Number of stem cell collected after GA101 administration Number of required collects to achieve 3Mcells/kg.
• Early metabolic response according to PET after 2 and 4 cycles
Based on results of central PET review

Full Information

First Posted
July 4, 2012
Last Updated
March 6, 2018
Sponsor
The Lymphoma Academic Research Organisation
Collaborators
Hoffmann-La Roche
search

1. Study Identification

Unique Protocol Identification Number
NCT01659099
Brief Title
GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma
Acronym
GAINED
Official Title
Randomized Phase III Study Using a Pet-driven Strategy and Comparing GA101 OR Rituximab Associated to a Chemotherapy Delivered Every 14 Days (ACVBP or CHOP) in DLBCL CD20+ Lymphoma Untreated Patients From 18 to 60 Presenting With 1 or More Adverse Prognostic Factors of the Age-adjusted IPI
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
experimental treatment not Superior to standard - no need to continue the follow-up
Study Start Date
September 2012 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Lymphoma Academic Research Organisation
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is designed to investigate: the interest of a new monoclonal antibody (GA101)versus rituximab the interest of PET to identify early responders Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm. The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B Cell Lymphoma CD20 Positive
Keywords
DLBCL, aa-IPI > or equal to 1, Diagnosis, 18 to 60 years, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
671 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GA101
Arm Type
Experimental
Arm Description
GA101 - Chemotherapy (ACVBP or CHOP)
Arm Title
Rituximab
Arm Type
Active Comparator
Arm Description
Rituximab - Chemotherapy (ACVBP or CHOP)
Intervention Type
Drug
Intervention Name(s)
GA101
Other Intervention Name(s)
obinutuzumab, Gazivaro
Intervention Description
in GA-ACBVP or in GA-CHOP 1000 mg on D1 and D8 (D8 in cycle 1 and 2)
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera
Intervention Description
in R-ACBVP or in R-CHOP 375 mg/m² on D1
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5
Intervention Type
Drug
Intervention Name(s)
Bleomycin
Intervention Description
in ACBVP 10 mg from D1 to D5
Intervention Type
Drug
Intervention Name(s)
Vindesin
Intervention Description
in ACBVP 2 mg/m² from D1 to D5
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
in CHOP 1,4 mg/m² on D1
Primary Outcome Measure Information:
Title
2-year Event Free Survival
Description
EFS is defined as PET positivity according to ΔSUVmax criteria after 2 or 4 induction cycles as defined by RAC (based on central PET review), progression or relapse according to Cheson 2007, modification of planned treatment out of progression or death of any cause.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
• Overall Response rate and Best overall response after 4 cycles and end of treatment according to Cheson 2007 criteria
Description
Response will be assessed after 4 cycles and again at the end of treatment, based on RAC assessment for PET 4 and investigator assessment for EoT PET. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 2007). Overall (CR//PR) response rates and Best Response Rate will be presented. Patient without response assessment (due to whatever reason) will be considered as non-responder.
Time Frame
Up to 3.5years
Title
• Overall Response Rate and Best overall response after 4 cycles and end of treatment according to Cheson 1999 criteria
Description
Response will be assessed after 4 cycles and at the end of treatment, based on investigator assessment. Assessment of response will be based on the International Workshop to Standardize Response criteria for NHL Criteria for evaluation of response in Non-Hodgkin's lymphoma (Cheson, 1999). Overall (CR/CRu/PR) response rates and Best Overall Response Rate will be presented. Patient without response assessment (due to whatever reason) will be considered as non-responder.
Time Frame
Up to 3.5 years
Title
• Duration of response (DoR)
Description
Duration of response is defined as the period from the time of attainment a CR or PR to the date of progression, relapse or death from any cause. Duration or response would be assessed as survival in the whole population, in the two inductive arms (R-Chemo14 vs GA101-Chemo14) For patients achieving a response but who have not progressed or relapsed or died at the time of analysis, DOR will be censored on the date of last disease assessment
Time Frame
Up to 6.5 years
Title
• Progression-Free Survival (PFS)
Description
Progression-Free Survival is defined as the period from the date of randomization to the date of first documented disease progression, relapse, or death from any cause. For patients who have not progressed, relapsed, or died at the time of analysis, PFS will be censored on the date of last disease assessment. If no tumor assessments were performed after the baseline visit, PFS will be censored at the time of randomization
Time Frame
Up to 6.5 years
Title
• Overall survival (OS)
Description
Overall survival is defined as the period from the date of randomization to the date of death from any cause. Alive patients at the time of the analysis will be censored at their last contact date
Time Frame
Up to 6.5 years
Title
• Blood samples and on tumor tissue biopsy
Description
Analysis on blood samples and tumor tissue biopsy will be driven, in order to explore prognosis factors of the patients and their tumors that influence treatment response based on PET assessment and prognosis
Time Frame
Up to 6.5 years
Title
• Focus on subpopulation
Description
Duration of response, PFS and OS will be performed according to treatment arms (R-Chemo14 vs GA101-Chemo14) on different analysis populations. The subpopulations are based on the outcome during the induction phase and a statistical bias could be introduced as subpopulations have not been defined at baseline. Population with a Δ SUVmaxPET0-2≤66% (slow and intermediate responders), Population with a Δ SUVmaxPET0-2>66% (fast responders), Patients submitted to autologous stem cell transplant (PFS and OS only)
Time Frame
Up to 6.5 years
Title
Number of stem cell collected after GA101 treatment
Description
Number of stem cell collected after GA101 administration Number of required collects to achieve 3Mcells/kg.
Time Frame
Up to 3.5 years
Title
• Early metabolic response according to PET after 2 and 4 cycles
Description
Based on results of central PET review
Time Frame
Up to 3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification) Baseline PET scan available with at least one hypermetabolic lesion Aged ≥ 18 years and ≤ 60 years Eligible for autologous stem cell transplant Patient not previously treated Age adjusted International Prognostic Index (aa-IPI) equal to 1, 2 or 3 Life expectancy ≥ 3 months Negative HIV, HBV (anti-HBc negativity) and HCV serologies before inclusion Having signed a written informed consent Having ability and willingness to comply with study protocol procedures Men must agree to use a barrier method of contraception during the treatment period and until 3 months after the last dose of GA101 or rituximab, or ACVBP14 or CHOP14 chemotherapy, whichever is longer Women of childbearing potential must agree to use an adequate method of contraception, such as oral contraceptives, intrauterine device, or barrier method of contraception during the treatment period and until 12 months after the last dose of GA101, Rituximab, ACVBP14, or CHOP14 chemotherapy, whichever is longer Exclusion Criteria: Any other histological type of lymphoma Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included Central nervous system or meningeal involvement by lymphoma Contra-indication to any drug contained in the chemotherapy regimens Poor cardiac function (LVEF < 50%) on echocardiogram or MUGA scan Poor renal function (creatinine level > 150*mol/l or clearance < 30ml/min), poor hepatic function (total bilirubin level > 30µmol/l, transaminases > 2.5 X maximum normal level) unless these abnormalities are related to the lymphoma Poor bone marrow reserve as defined by neutrophils < 1.5 G/L or platelets < 100 G/L, unless related to bone marrow infiltration Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma Any serious active disease (according to the investigator's decision) Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy Pregnant or lactating women Adult patient under tutelage Prior history of Progressive Multifocal Leukoencephalopathy (PML)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Casasnovas, MD
Organizational Affiliation
Lymphoma Study Association
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steven Le Gouill, MD
Organizational Affiliation
Lymphoma Study Association
Official's Role
Study Chair
Facility Information:
Facility Name
ZNA Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Hôpital Saint Joseph
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
RHMS Baudour
City
Baudour
ZIP/Postal Code
7331
Country
Belgium
Facility Name
AZ St Jan Brugge Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
CHU Brugmann
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Hôpital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Clinique universitaire Saint LUC
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
CHU de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Grand Hôpital de Charleroi
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
900
Country
Belgium
Facility Name
Ch Jolimont
City
Haine Saint Paul
ZIP/Postal Code
7100
Country
Belgium
Facility Name
AZ GROENINGE - Oncology Centre - Campus Maria's Voorzienigheid
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHR de la Citadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU de Liège - Clinique Saint Joseph
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU de Liège -Domaine Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Ambroise Paré
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Clinique Saint Joseph -Hôpital de Warquignies
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
Clinique 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
Centre Hospitalier de Wallonie Picarde - CHwapi
City
Tournai
ZIP/Postal Code
7500
Country
Belgium
Facility Name
CH de la Tourelle-Peltzer
City
Verviers
ZIP/Postal Code
4800
Country
Belgium
Facility Name
Université Catholique de Louvain Mont Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
CH d'Abbeville
City
Abbeville
ZIP/Postal Code
80142
Country
France
Facility Name
CHU d'Amiens - Hôpital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
CH Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
CH d'Arras
City
Arras
ZIP/Postal Code
62022
Country
France
Facility Name
CH d'Avignon
City
Avignon
ZIP/Postal Code
84902
Country
France
Facility Name
Hôpital de Bayonne - CHU de la Côte Basque
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
CH de Beauvais
City
Beauvais
ZIP/Postal Code
60000
Country
France
Facility Name
CHU de Besançon - Hôpital Jean Minjoz
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
CH de Blois
City
Blois
ZIP/Postal Code
41016
Country
France
Facility Name
APHP - Hôpital Avicenne
City
Bobigny
ZIP/Postal Code
93000
Country
France
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Polyclinique Bordeaux Nord Aquitaine
City
Bordeaux
ZIP/Postal Code
33077
Country
France
Facility Name
CH Dr Duchenne
City
Boulogne sur Mer
ZIP/Postal Code
62321
Country
France
Facility Name
CH Fleyriat
City
Bourg en Bresse
ZIP/Postal Code
01012
Country
France
Facility Name
CHU de Brest - Hôpital de Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CH Brive la Gaillarde
City
Brive la Gaillarde
ZIP/Postal Code
19100
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Centre François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
CH de Cannes
City
Cannes
ZIP/Postal Code
06400
Country
France
Facility Name
Clinique Du Parc
City
Castelnau Le Lez
ZIP/Postal Code
34170
Country
France
Facility Name
CH de Chambéry
City
Chambéry
ZIP/Postal Code
73011
Country
France
Facility Name
CHU de Châlon sur Saône
City
Châlon sur Saône
ZIP/Postal Code
71100
Country
France
Facility Name
APHP - Hôpital Antoine Béclère
City
Clamart
ZIP/Postal Code
92140
Country
France
Facility Name
Hôpital d'Instruction des Armées Percy
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
CHU d'Estaing
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Pôle Santé Publique
City
Clermont Ferrand
ZIP/Postal Code
63050
Country
France
Facility Name
CH de Compiègne
City
Compiègne
ZIP/Postal Code
60200
Country
France
Facility Name
CH Sud Francilien
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
APHP - Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CH de Dunkerque
City
Dunkerque
ZIP/Postal Code
59385
Country
France
Facility Name
Institut Daniel Hollard
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHD Vendée
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
CH La Rochelle
City
La Rochelle
ZIP/Postal Code
17019
Country
France
Facility Name
APHP - Hôpital Bicêtre
City
Le Kremlin Bicêtre
ZIP/Postal Code
94275
Country
France
Facility Name
CH du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CH de Lens
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
CH Saint Vincent de Paul
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHRU Lille - Hôpital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU Dupruytren - Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CH Bretagne Sud
City
Lorient
ZIP/Postal Code
56100
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
CH Mantes La Jolie
City
Mantes La Jolie
ZIP/Postal Code
78201
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13009
Country
France
Facility Name
CH de Meaux
City
Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
CH Marc Jacquet
City
Melun
ZIP/Postal Code
77011
Country
France
Facility Name
Hôpital Notre Dame Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
CHI de Meulan
City
Meulan en Yvelines
ZIP/Postal Code
78250
Country
France
Facility Name
CHU de Montpellier - Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Val d'Aurélie - Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Auréen de Cancérologie
City
Mougins
ZIP/Postal Code
06250
Country
France
Facility Name
CH de Mulhouse - Hôpital Emile Muller
City
Mulhouse Cedex
ZIP/Postal Code
68070
Country
France
Facility Name
CHU de Nantes - Hôtel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Catherine de Sienne
City
Nantes
ZIP/Postal Code
44200
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice Cedex 2
ZIP/Postal Code
06189
Country
France
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CHU de Nîmes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
Clinique Valdegour
City
Nîmes
ZIP/Postal Code
30900
Country
France
Facility Name
CHR d'Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Facility Name
APHP - Hôpital Saint Louis
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
APHP - Hôpital Saint Antoine
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
APHP - Hôpital de la Pitié Salpetrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
APHP - Hôpital Necker
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
CH Saint Jean
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
CHU de Haut Lévèque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hospices Civils de Lyon - CHU Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
CH René Dubos
City
Pontoise
ZIP/Postal Code
95300
Country
France
Facility Name
CH d'Annecy
City
Pringy
ZIP/Postal Code
74370
Country
France
Facility Name
CHU Robert Debré
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
Institut du Cancer de Courlancy
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CH de Roubaix
City
Roubaix
ZIP/Postal Code
59100
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Clinique Mathilde
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
CH Yves Le Foll - St Brieuc
City
Saint Brieuc
ZIP/Postal Code
22000
Country
France
Facility Name
Centre René Huguenin
City
Saint Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
CHI de Poissy St Germain
City
Saint germain en laye
ZIP/Postal Code
78105
Country
France
Facility Name
CHU de Saint Malo
City
Saint Malo
ZIP/Postal Code
35400
Country
France
Facility Name
CH de Saint Quentin
City
Saint Quentin
ZIP/Postal Code
21000
Country
France
Facility Name
Institut de Cancérologie
City
St Priest en Jarez
ZIP/Postal Code
42270
Country
France
Facility Name
Strasbourg Oncologie Libérale
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital Saint Husse
City
Toulon
ZIP/Postal Code
83100
Country
France
Facility Name
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
CHU de Valence
City
Valence
ZIP/Postal Code
26953
Country
France
Facility Name
CH de Valenciennes
City
Valenciennes
ZIP/Postal Code
59322
Country
France
Facility Name
CHU de Brabois
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
CH Bretagne Atlantique
City
Vannes
ZIP/Postal Code
56017
Country
France
Facility Name
CH de Versailles
City
Versailles
ZIP/Postal Code
78750
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
84085
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
34572728
Citation
Jullien M, Tessoulin B, Ghesquieres H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Lamy T, Thieblemont C, Villemagne B, Gressin R, Bouabdallah K, Haioun C, Damaj G, Fornecker LM, Schiano De Colella JM, Feugier P, Hermine O, Cartron G, Bonnet C, Andre M, Bailly C, Casasnovas RO, Le Gouill S. Deep-Learning Assessed Muscular Hypodensity Independently Predicts Mortality in DLBCL Patients Younger Than 60 Years. Cancers (Basel). 2021 Sep 7;13(18):4503. doi: 10.3390/cancers13184503.
Results Reference
derived
PubMed Identifier
33211799
Citation
Le Gouill S, Ghesquieres H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Lamy T, Thieblemont C, Maisonneuve H, Gressin R, Bouhabdallah K, Haioun C, Damaj G, Fornecker L, Bouhabdallah R, Feugier P, Sibon D, Cartron G, Bonnet C, Andre M, Chartier L, Ruminy P, Kraeber-Bodere F, Bodet-Milin C, Berriolo-Riedinger A, Briere J, Jais JP, Molina TJ, Itti E, Casasnovas RO. Obinutuzumab vs rituximab for advanced DLBCL: a PET-guided and randomized phase 3 study by LYSA. Blood. 2021 Apr 29;137(17):2307-2320. doi: 10.1182/blood.2020008750.
Results Reference
derived
PubMed Identifier
33097974
Citation
Blanc-Durand P, Jegou S, Kanoun S, Berriolo-Riedinger A, Bodet-Milin C, Kraeber-Bodere F, Carlier T, Le Gouill S, Casasnovas RO, Meignan M, Itti E. Fully automatic segmentation of diffuse large B cell lymphoma lesions on 3D FDG-PET/CT for total metabolic tumour volume prediction using a convolutional neural network. Eur J Nucl Med Mol Imaging. 2021 May;48(5):1362-1370. doi: 10.1007/s00259-020-05080-7. Epub 2020 Oct 24.
Results Reference
derived

Learn more about this trial

GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

We'll reach out to this number within 24 hrs