Study Results
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Basic Information
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TERMINATED
PHASE3
671 participants
INTERVENTIONAL
2012-09-30
2017-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GA101
GA101 - Chemotherapy (ACVBP or CHOP)
GA101
in GA-ACBVP or in GA-CHOP 1000 mg on D1 and D8 (D8 in cycle 1 and 2)
Doxorubicin
in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1
Cyclophosphamide
in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1
Prednisone
in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5
Bleomycin
in ACBVP 10 mg from D1 to D5
Vindesin
in ACBVP 2 mg/m² from D1 to D5
Vincristine
in CHOP 1,4 mg/m² on D1
Rituximab
Rituximab - Chemotherapy (ACVBP or CHOP)
Rituximab
in R-ACBVP or in R-CHOP 375 mg/m² on D1
Doxorubicin
in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1
Cyclophosphamide
in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1
Prednisone
in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5
Bleomycin
in ACBVP 10 mg from D1 to D5
Vindesin
in ACBVP 2 mg/m² from D1 to D5
Vincristine
in CHOP 1,4 mg/m² on D1
Interventions
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GA101
in GA-ACBVP or in GA-CHOP 1000 mg on D1 and D8 (D8 in cycle 1 and 2)
Rituximab
in R-ACBVP or in R-CHOP 375 mg/m² on D1
Doxorubicin
in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1
Cyclophosphamide
in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1
Prednisone
in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5
Bleomycin
in ACBVP 10 mg from D1 to D5
Vindesin
in ACBVP 2 mg/m² from D1 to D5
Vincristine
in CHOP 1,4 mg/m² on D1
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
60 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
The Lymphoma Academic Research Organisation
OTHER
Responsible Party
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Principal Investigators
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Olivier Casasnovas, MD
Role: STUDY_CHAIR
Lymphoma Study Association
Steven Le Gouill, MD
Role: STUDY_CHAIR
Lymphoma Study Association
Locations
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ZNA Stuivenberg
Antwerp, , Belgium
Hôpital Saint Joseph
Arlon, , Belgium
RHMS Baudour
Baudour, , Belgium
AZ St Jan Brugge Oostende AV
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
CHU Brugmann
Brussels, , Belgium
Hôpital Erasme
Brussels, , Belgium
Clinique universitaire Saint LUC
Brussels, , Belgium
CHU de Charleroi
Charleroi, , Belgium
Grand Hôpital de Charleroi
Charleroi, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Ch Jolimont
Haine-Saint-Paul, , Belgium
AZ GROENINGE - Oncology Centre - Campus Maria's Voorzienigheid
Kortrijk, , Belgium
CHR de la Citadelle
Liège, , Belgium
CHU de Liège - Clinique Saint Joseph
Liège, , Belgium
CHU de Liège -Domaine Sart Tilman
Liège, , Belgium
CHU Ambroise Paré
Mons, , Belgium
Clinique Saint Joseph -Hôpital de Warquignies
Mons, , Belgium
Clinique Sainte Elisabeth
Namur, , Belgium
Clinique Saint Pierre
Ottignies, , Belgium
Heilig Hart Ziekenhuis
Roeselare, , Belgium
Centre Hospitalier de Wallonie Picarde - CHwapi
Tournai, , Belgium
CH de la Tourelle-Peltzer
Verviers, , Belgium
Université Catholique de Louvain Mont Godinne
Yvoir, , Belgium
CH d'Abbeville
Abbeville, , France
CHU d'Amiens - Hôpital Sud
Amiens, , France
CHU d'Angers
Angers, , France
CH Victor Dupouy
Argenteuil, , France
CH d'Arras
Arras, , France
CH d'Avignon
Avignon, , France
Hôpital de Bayonne - CHU de la Côte Basque
Bayonne, , France
CH de Beauvais
Beauvais, , France
CHU de Besançon - Hôpital Jean Minjoz
Besançon, , France
CH de Blois
Blois, , France
APHP - Hôpital Avicenne
Bobigny, , France
Institut Bergonié
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
CH Dr Duchenne
Boulogne-sur-Mer, , France
CH Fleyriat
Bourg-en-Bresse, , France
CHU de Brest - Hôpital de Morvan
Brest, , France
CH Brive la Gaillarde
Brive-la-Gaillarde, , France
CHU de Caen
Caen, , France
Centre François Baclesse
Caen, , France
CH de Cannes
Cannes, , France
Clinique Du Parc
Castelnau-le-Lez, , France
CH de Chambéry
Chambéry, , France
CHU de Châlon sur Saône
Châlon Sur Saône, , France
APHP - Hôpital Antoine Béclère
Clamart, , France
Hôpital d'Instruction des Armées Percy
Clamart, , France
CHU d'Estaing
Clermont-Ferrand, , France
Pôle Santé Publique
Clermont-Ferrand, , France
CH de Compiègne
Compiègne, , France
CH Sud Francilien
Corbeil-Essonnes, , France
APHP - Hôpital Henri Mondor
Créteil, , France
CHU de Dijon
Dijon, , France
CH de Dunkerque
Dunkirk, , France
Institut Daniel Hollard
Grenoble, , France
CHU de Grenoble
Grenoble, , France
CHD Vendée
La Roche-sur-Yon, , France
CH La Rochelle
La Rochelle, , France
APHP - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CH du Mans
Le Mans, , France
Clinique Victor Hugo
Le Mans, , France
CH de Lens
Lens, , France
CH Saint Vincent de Paul
Lille, , France
CHRU Lille - Hôpital Claude Huriez
Lille, , France
CHU Dupruytren - Limoges
Limoges, , France
CH Bretagne Sud
Lorient, , France
Centre Léon Bérard
Lyon, , France
CH Mantes La Jolie
Mantes-la-Jolie, , France
Hôpital de la Conception
Marseille, , France
Institut Paoli Calmettes
Marseille, , France
CH de Meaux
Meaux, , France
CH Marc Jacquet
Melun, , France
Hôpital Notre Dame Bon Secours
Metz, , France
CHI de Meulan
Meulan-en-Yvelines, , France
CHU de Montpellier - Saint Eloi
Montpellier, , France
Centre Val d'Aurélie - Paul Lamarque
Montpellier, , France
Centre Auréen de Cancérologie
Mougins, , France
CH de Mulhouse - Hôpital Emile Muller
Mulhouse, , France
CHU de Nantes - Hôtel Dieu
Nantes, , France
Centre Catherine de Sienne
Nantes, , France
Centre Antoine Lacassagne
Nice, , France
CHU de Nice
Nice, , France
CHU de Nîmes
Nîmes, , France
Clinique Valdegour
Nîmes, , France
CHR d'Orléans
Orléans, , France
Institut Curie
Paris, , France
APHP - Hôpital de la Pitié Salpetrière
Paris, , France
Hôpital Cochin
Paris, , France
APHP - Hôpital Necker
Paris, , France
APHP - Hôpital Saint Louis
Paris, , France
APHP - Hôpital Saint Antoine
Paris, , France
CH Saint Jean
Perpignan, , France
CHU de Haut Lévèque
Pessac, , France
Hospices Civils de Lyon - CHU Lyon Sud
Pierre-Bénite, , France
CHU de Poitiers
Poitiers, , France
CH René Dubos
Pontoise, , France
CH d'Annecy
Pringy, , France
CHU Robert Debré
Reims, , France
Institut du Cancer de Courlancy
Reims, , France
CHU de Rennes
Rennes, , France
CH de Roubaix
Roubaix, , France
Centre Henri Becquerel
Rouen, , France
Clinique Mathilde
Rouen, , France
CH Yves Le Foll - St Brieuc
Saint-Brieuc, , France
Centre René Huguenin
Saint-Cloud, , France
CHI de Poissy St Germain
Saint-Germain-en-Laye, , France
Institut de Cancérologie
Saint-Priest-en-Jarez, , France
CH de Saint Quentin
Saint-Quentin, , France
CHU de Saint Malo
St-Malo, , France
Strasbourg Oncologie Libérale
Strasbourg, , France
CHU de Strasbourg
Strasbourg, , France
Hopital Saint Husse
Toulon, , France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)
Toulouse, , France
CHU de Tours
Tours, , France
CHU de Valence
Valence, , France
CH de Valenciennes
Valenciennes, , France
CHU de Brabois
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique
Vannes, , France
CH de Versailles
Versailles, , France
Institut Gustave Roussy
Villejuif, , France
Countries
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References
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Camus V, Molina T, Desmots F, Blanc-Durand P, Kanoun S, Moslemi A, Ruminy P, Le Gouill S, Ghesquieres H, Oberic L, Morschhauser F, Tilly H, Ribrag V, Houot R, Thieblemont C, Maisonneuve H, Claves F, Bouabdallah K, Haioun C, Damaj GL, Fornecker LM, Noel R, Feugier P, Sibon D, Cartron G, Bonnet C, Bernard W, Kraeber-Bodere F, Bodet-Milin C, Jais JP, Briere J, Rossi C, Elsensohn MH, Chartier L, Itti E, Jardin F, Fest T. Interim PET after 4 cycles predicts outcome in histomolecularly confirmed primary mediastinal B-cell lymphoma. Blood Adv. 2025 May 13;9(9):2232-2246. doi: 10.1182/bloodadvances.2024015577.
Itti E, Blanc-Durand P, Berriolo-Riedinger A, Kanoun S, Kraeber-Bodere F, Meignan M, Gat E, Gouill SL, Casasnovas RO, Bodet-Milin C. Validation of the DeltaSUVmax for Interim PET Interpretation in Diffuse Large B-Cell Lymphoma on the Basis of the GAINED Clinical Trial. J Nucl Med. 2023 Nov;64(11):1706-1711. doi: 10.2967/jnumed.123.265871. Epub 2023 Sep 21.
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.
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.
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.
Other Identifiers
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GAINED
Identifier Type: -
Identifier Source: org_study_id
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