drugset / Trial / NCT02451111

Rituximab With or Without Ibrutinib for Patients With Advanced Follicular Lymphoma

NCT02451111

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Follicular lymphomas FL has been traditionally approached either by an initial watch and wait policy in the asymptomatic patient, or with single agent treatments with the purpose of maintaining a good quality of life for a prolonged time.The combination of rituximab and ibrutinib has been tested in clinical trials and appeared to be well tolerated and active. Since ibrutinib seems to achieve better results when administered for prolonged time as shown in CLL, the investigators have chosen to compare its combination with rituximab to the prolonged rituximab-only schedule that was already shown to be very active in the SAKK 35/03 trial. The aim of the study is to investigate the efficacy, safety and tolerability of the treatment combination of Ibrutinib and Rituximab for patients with advanced follicular lymphoma in need of therapy.

Timeline

Start
2015-11-06
Primary completion
2022-12-01
Completion
2023-07-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ibrutinib Small molecule 560 mg Oral
Comparator Rituximab Monoclonal antibody 1400 mg Intravenous

Indications