GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

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.

Timeline

Start

2012-09

Primary completion

2016-08

Completion

2017-12-31

Publications

• 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.

Drugs

Indications