Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma

Summary

Single arm phase II study of Chlorambucil in combination with subcutaneous Rituximab followed by maintenance therapy with subcutaneous Rituximab in patients with histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site, either de novo, or relapsed following local therapy (including surgery, radiotherapy and antibiotics for H. pylori-positive gastric lymphoma).

Timeline

Start

2013-12

Primary completion

2016-03

Completion

2028-09

Outcome

Missed primary endpoint

paper The trial showed that SC rituximab did not improve the CR rate at the conclusion of the induction phase, which was the main endpoint. PMID 38385243 ↗

Publications

• Stathis A, Pirosa MC, Orsucci L, Feugier P, Tani M, Ghesquieres H, Musuraca G, Rossi FG, Merli F, Guieze R, Gyan E, Gini G, Marino D, Gressin R, Morschhauser F, Cavallo F, Palombi F, Conconi A, Tessoulin B, Tilly H, Zanni M, Cabras MG, Capochiani E, Califano C, Celli M, Pulsoni A, Angrilli F, Occhini U, Casasnovas RO, Cartron G, Devizzi L, Haioun C, Liberati AM, Houot R, Merli M, Pietrantuono G, Re F, Spina M, Landi F, Cavalli F, Bertoni F, Rossi D, Ielmini N, Borgo E, Luminari S, Zucca E, Thieblemont C. IELSG38: phase II trial of front-line chlorambucil plus subcutaneous rituximab induction and maintenance in mucosa-associated lymphoid tissue lymphoma. Haematologica. 2024 Aug 1;109(8):2564-2573. doi: 10.3324/haematol.2023.283918.

Drugs

Indications