drugset / Trial / NCT02896582
Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance
NaSingle-groupOpen-labelTreatment
Summary
This study is a multicentric, single arm phase II trial to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by Cisplatinum-Cytarabine-Dexamethasone (DHAP) followed by autologous transplantation plus obinutuzumab maintenance then Molecular Residual Disease (MRD) driven maintenance
Timeline
- Start
- 2016-11-29
- Primary completion
- 2019-03
- Completion
- 2024-12-02
Publications
- Sarkozy C, Callanan M, Thieblemont C, Oberic L, Burroni B, Bouabdallah K, Damaj G, Tessoulin B, Ribrag V, Houot R, Morschhauser F, Griolet S, Joubert C, Cacheux V, Delwail V, Safar V, Gressin R, Cheminant M, Delfau-Larue MH, Hermine O, Macintyre E, Le Gouill S. Obinutuzumab vs rituximab for transplant-eligible patients with mantle cell lymphoma. Blood. 2024 Jul 18;144(3):262-271. doi: 10.1182/blood.2024023944.
- Bodet-Milin C, Morvant C, Carlier T, Frecon G, Tournilhac O, Safar V, Kraeber-Bodere F, Le Gouill S, Macintyre E, Bailly C. Performance of baseline FDG-PET/CT radiomics for prediction of bone marrow minimal residual disease status in the LyMa-101 trial. Sci Rep. 2023 Oct 24;13(1):18177. doi: 10.1038/s41598-023-45215-y.
- Le Gouill S, Beldi-Ferchiou A, Alcantara M, Cacheux V, Safar V, Burroni B, Guidez S, Gastinne T, Canioni D, Thieblemont C, Maisonneuve H, Bodet-Milin C, Houot R, Oberic L, Bouabdallah K, Bescond C, Damaj G, Jaccard A, Daguindau N, Moreau A, Tilly H, Ribrag V, Delfau-Larue MH, Hermine O, Macintyre E. Molecular response after obinutuzumab plus high-dose cytarabine induction for transplant-eligible patients with untreated mantle cell lymphoma (LyMa-101): a phase 2 trial of the LYSA group. Lancet Haematol. 2020 Nov;7(11):e798-e807. doi: 10.1016/S2352-3026(20)30291-X. Epub 2020 Sep 21.
- Bailly C, Carlier T, Berriolo-Riedinger A, Casasnovas O, Gyan E, Meignan M, Moreau A, Burroni B, Djaileb L, Gressin R, Devillers A, Lamy T, Thieblemont C, Hermine O, Kraeber-Bodere F, Le Gouill S, Bodet-Milin C. Prognostic value of FDG-PET in patients with mantle cell lymphoma: results from the LyMa-PET Project. Haematologica. 2020 Jan;105(1):e33-e36. doi: 10.3324/haematol.2019.223016. Epub 2019 Aug 1. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | — |
| Background | Cytarabine | Small molecule | 400 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | Intravenous |
| Background | Etoposide | Small molecule | 400 mg/m2 | — |
| Background | Melphalan | Small molecule | 140 mg/m2 | — |
| Background | carmustine | Small molecule | 300 mg/m2 | — |