A phase II study of rituximab plus lenalidomide for mucosa-associated lymphoid tissue lymphoma (MALT lymphoma)
Mené sur 46 patients atteints d'un lymphome avancé du tissu lymphoïde associé aux muqueuses, cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse objective, et la toxicité d'un traitement combinant rituximab et lénalidomide
The AGMT MALT-2 trial is the first phase II study exploring the efficacy and safety of R-lenalidomide in MALT lymphoma patients.With a response rate of 80% this study shows that the combination is feasible and active irrespective of inital site or prior treatment. Chemotherapy-containing regimens are effective for the treatment of advanced MALT lymphoma but due to the indolent course of this disease investigating the use of immunomodulatory, chemotherapy-free strategies appears reasonable. Based on the activity of lenalidomide (LEN) monotherapy for MALT lymphoma and promising results with LEN plus rituximab (R) in several B-cell malignancies, we have studied this combination for MALT lymphoma. In this multicenter phase II study (AGMT MALT-2), patients received R 375 mg/m2 d1 and LEN 20 mg d1-21 every four weeks. In case of complete remission after six courses, treatment was stopped, while patients with partial remission or stabilization were eligible to receive eight courses. The primary endpoint was the objective response rate and the secondary endpoint safety. A total of 46 evaluable patients were enrolled according to protocol. Out of these, 30% had gastric MALT lymphoma while the majority had extragastric primary manifestations. Eleven patients (24%) had received prior systemic treatment. The overall response rate was 80% (37/46; 95%CI 69-92%) with 54% (25/46) complete remissions and 26% (12/46) partial remissions while 17% (8/46) had stable disease as best response and one patient progressed. Treatment was equally effective for pretreated/ naïve (p=0.999) and gastric/ extragastric patients (p=0.701). The median time to best response was 3.6 months. No unexpected toxicities were observed. This is the first study on the efficacy of R-LEN in MALT lymphoma. With an overall response rate of 80% and 54% complete remissions we could improve results achieved with lenalidomide monotherapy in a prior pilot trial.%U http://www.bloodjournal.org/content/bloodjournal/early/2016/11/22/blood-2016-06-720599.full.pdf